Trial Outcomes & Findings for Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma (NCT NCT03484702)
NCT ID: NCT03484702
Last Updated: 2024-12-27
Results Overview
Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: No * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: No * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: No * Organ enlargement: Spleen length decreased \> 50% * New lesions: No
COMPLETED
PHASE2
113 participants
From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
2024-12-27
Participant Flow
During the pretreatment period participants underwent leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants entered the treatment period and received lymphodepleting chemotherapy followed by infusion of JCAR017. Cohort 6 was planned but subsequently removed from the study. No participants were enrolled into Cohort 6.
Participant milestones
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Pre-Treatment Period - Leukapheresis
STARTED
|
45
|
32
|
14
|
4
|
7
|
11
|
|
Pre-Treatment Period - Leukapheresis
COMPLETED
|
43
|
27
|
12
|
1
|
5
|
10
|
|
Pre-Treatment Period - Leukapheresis
NOT COMPLETED
|
2
|
5
|
2
|
3
|
2
|
1
|
|
Treatment Period
STARTED
|
43
|
27
|
12
|
1
|
5
|
10
|
|
Treatment Period
JCAR017 Treated Set
|
36
|
27
|
10
|
1
|
5
|
9
|
|
Treatment Period
COMPLETED
|
39
|
24
|
12
|
1
|
5
|
9
|
|
Treatment Period
NOT COMPLETED
|
4
|
3
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Treatment Period
Death
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Participant Withdrew from Study
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=45 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=32 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=14 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=4 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=7 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=11 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.2 Years
STANDARD_DEVIATION 10.60 • n=5 Participants
|
73.3 Years
STANDARD_DEVIATION 5.50 • n=7 Participants
|
57.6 Years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 21.11 • n=4 Participants
|
57.0 Years
STANDARD_DEVIATION 5.74 • n=21 Participants
|
58.1 Years
STANDARD_DEVIATION 12.47 • n=8 Participants
|
63.3 Years
STANDARD_DEVIATION 11.56 • n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
71 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
79 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
71 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1,2, and 3 only.
Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: No * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: No * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: No * Organ enlargement: Spleen length decreased \> 50% * New lesions: No
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=36 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=27 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3
|
61.1 Percent of Participants
Interval 43.5 to 76.9
|
63.0 Percent of Participants
Interval 42.4 to 80.6
|
70.0 Percent of Participants
Interval 34.8 to 93.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 4 only.
Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: None/normal * Organ enlargement: Spleen length decreased \> 50% * New lesions: No
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) Per Investigator in Cohort 4
|
100 Percent of Participants
Interval 100.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 5 only.
Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR). Complete response (CR): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative Partial response (PR): * Brain imaging: 50% decrease in enhancing tumor, no contrast enhancement. * Corticosteroid dose: Irrelevant * Eye examination: Minor RPE abnormality, decrease in vitreous cells or retinal infiltrate. * Cerebrospinal fluid cytology: Negative, persistent or suspicious
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) Per Investigator in Cohort 5
|
80.0 Percent of Participants
Interval 28.4 to 99.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From leukapheresis to end of study (up to approximately 63 months)Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events in Cohort 7
AEs occurring between Day 31 and Day 90
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events in Cohort 7
AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events in Cohort 7
AEs occurring between LDC and JCAR017 infusion
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events in Cohort 7
AEs occurring between JCAR017 infusion and Day 30
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events in Cohort 7
AEs occurring between Day 91 and end of study
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From leukapheresis to end of study (up to approximately 63 months)Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only
A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohort 7
SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohort 7
SAEs occurring between LDC and JCAR017 infusion
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohort 7
SAEs occurring between JCAR017 infusion and Day 30
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohort 7
SAEs occurring between Day 31 and Day 90
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohort 7
SAEs occurring between Day 91 and end of study
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Baseline and Day 29 after JCAR017 infusionPopulation: All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohort 7 only
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7
Leukocytes (10^9/L) - Day 29
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7
Neutrophils, Segmented (10^9/L) - Day 29
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7
Platelets (10^9/L) - Day 29
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7
Activated Partial Thromboplastin Time (sec) - Day 29
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7
Prothrombin Intl. Normalized Ratio - Day 29
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Baseline and Day 29 after JCAR017 infusionPopulation: All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohort 7 only
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
Albumin (g/L) - Day 29
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
Phosphate (mmol/L) - Day 29
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
Alkaline Phosphatase (U/L) - Day 29
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
Alanine Aminotransferase (U/L) - Day 29
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
Aspartate Aminotransferase (U/L) - Day 29
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
Bilirubin (umol/L) - Day 29
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
Creatinine (umol/L) - Day 29
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
Triglycerides (mmol/L) - Day 29
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
Urate (umol/L) - Day 29
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From leukapheresis to end of study (up to approximately 63 months)Population: All participants in the JCAR017 treated set. Prespecified to be reported for Cohorts 1, 2, 3, 4, and 5 only
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=36 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=27 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5
AEs occurring between Day 31 and Day 90
|
25 Participants
|
10 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5
AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
|
5 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5
AEs occurring between LDC and JCAR017 infusion
|
29 Participants
|
23 Participants
|
8 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5
AEs occurring between JCAR017 infusion and Day 30
|
36 Participants
|
26 Participants
|
10 Participants
|
1 Participants
|
5 Participants
|
—
|
|
Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5
AEs occurring between Day 91 and end of study
|
10 Participants
|
9 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From leukapheresis to end of study (up to approximately 63 months)Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only
A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=36 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=27 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5
SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5
SAEs occurring between LDC and JCAR017 infusion
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5
SAEs occurring between JCAR017 infusion and Day 30
|
16 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5
SAEs occurring between Day 31 and Day 90
|
7 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5
SAEs occurring between Day 91 and end of study
|
5 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At Baseline and Day 29 after JCAR017 infusionPopulation: All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=33 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=21 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5
Leukocytes (10^9/L) - Day 29
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5
Neutrophils, Segmented (10^9/L) - Day 29
|
11 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5
Platelets (10^9/L) - Day 29
|
13 Participants
|
8 Participants
|
9 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5
Activated Partial Thromboplastin Time (sec) - Day 29
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5
Prothrombin Intl. Normalized Ratio - Day 29
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At Baseline and Day 29 after JCAR017 infusionPopulation: All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only.
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=35 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=24 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=4 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
Albumin (g/L) - Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
Phosphate (mmol/L) - Day 29
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
Alkaline Phosphatase (U/L) - Day 29
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
Alanine Aminotransferase (U/L) - Day 29
|
10 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
Aspartate Aminotransferase (U/L) - Day 29
|
6 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
Bilirubin (umol/L) - Day 29
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
Creatinine (umol/L) - Day 29
|
23 Participants
|
20 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
Triglycerides (mmol/L) - Day 29
|
10 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
Urate (umol/L) - Day 29
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only.
ORR by Independent Review Committee. ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: None/normal * Organ enlargement: Spleen length decreased \> 50% * New lesions: No
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in Cohort 7
|
88.9 Percent of Participants
Interval 51.8 to 99.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)Population: All participants in the JCAR017 treated set.
Complete response rate is defined as percentage of participants achieving a best overall response of complete response. Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Complete response (CR) (Cohort 5): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu) (Cohort 5): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=36 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=27 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Complete Response Rate (CRR)
|
33.3 Percent of Participants
Interval 18.6 to 51.0
|
48.1 Percent of Participants
Interval 28.7 to 68.1
|
50.0 Percent of Participants
Interval 18.7 to 81.3
|
0 Percent of Participants
Interval 0.0 to 0.0
|
0 Percent of Participants
Interval 0.0 to 0.0
|
88.9 Percent of Participants
Interval 51.8 to 99.7
|
SECONDARY outcome
Timeframe: From JCAR017 infusion to death due to any reason, progressive disease, or starting a new anticancer therapy (up to approximately 63 months).Population: All participants in the JCAR017 treated set.
Event-free survival is from JCAR017 infusion to death from any cause, progressive disease, or starting a new anticancer therapy. If a participant did not have an EFS event prior to data cutoff, EFS was censored at last disease assessment. Progressive disease (PD): * Target nodes/nodal masses: PPD progression. * Extranodal lesion: LDi \> 1.5 cm and increase by ≥ 50% from PPD nadir. * Splenomegaly: \> 50% of prior increase from baseline or by at least 2 cm from baseline. * Nonmeasured lesions: New or clear progression. * New lesions: Regrowth of previously resolved lesions. * Bone marrow: New or recurrent Progressive Disease (Cohort 5): * Brain imaging: \> 25% increase in enhancing lesion from baseline or best response. * Eye Exam: Increased vitreous cell counts or progressive retinal or optic nerve infiltration. * New lesion or site of disease
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=36 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=27 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Event Free Survival (EFS)
|
2.99 Months
Interval 2.6 to 5.22
|
3.12 Months
Interval 1.97 to 7.36
|
6.33 Months
Interval 0.56 to
Insufficient number of events to calculate upper limit of the CI using the K-M method.
|
23.95 Months
Interval 23.95 to 23.95
|
14.23 Months
Interval 0.76 to 24.02
|
NA Months
Interval 5.65 to
Insufficient number of events to calculate median and upper limit of the CI using the K-M method.
|
SECONDARY outcome
Timeframe: From JCAR017 infusion to progressive disease or death due to any reason, whichever occurred first (up to approximately 63 months)Population: All participants in the JCAR017 treated set.
Progression-free survival is defined as the interval from the date of JCAR017 infusion to progressive disease or death due to any cause, whichever occurred first. Per European Medicines Agency (EMA) criteria, participants who did not experience progressive disease and who did not die before the data cutoff date were censored at the time of the last visit with adequate response assessment when the participants were known not to have progressed. Estimated using Kaplan-Meier product-limit estimates.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=36 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=27 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria
|
2.99 Months
Interval 2.76 to 5.22
|
3.12 Months
Interval 1.97 to 7.36
|
6.33 Months
Interval 0.56 to
Insufficient number of events to calculate upper limit of the CI using the K-M method.
|
14.23 Months
Interval 0.76 to 24.02
|
23.95 Months
Interval 23.95 to 23.95
|
NA Months
Interval 5.65 to
Insufficient number of events to calculate median and upper limit of the CI using the K-M method.
|
SECONDARY outcome
Timeframe: From the date of JCAR017 infusion to the date of death due to any reason (up to approximately 63 months).Population: All participants in the JCAR017 treated set.
Overall survival is defined as the interval from the date of JCAR017 infusion to the date of death due to any reason. Data from surviving participants was censored at the last time that the participant was known to be alive. Estimated using Kaplan-Meier product-limit estimates.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=36 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=27 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
15.84 Months
Interval 5.82 to 23.95
|
16.82 Months
Interval 4.27 to
Insufficient number of events to calculate upper limit of the CI using the K-M method.
|
14.72 Months
Interval 1.71 to
Insufficient number of events to calculate upper limit of the CI using the K-M method.
|
31.74 Months
Interval 31.74 to 31.74
|
14.23 Months
Interval 4.3 to
Insufficient number of events to calculate upper limit of the CI using the K-M method.
|
NA Months
Interval 11.6 to
Insufficient number of events to calculate median and upper limit of the CI using the K-M method.
|
SECONDARY outcome
Timeframe: From JCAR017 infusion until disease progression, death due to any reason, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)Population: All participants in the JCAR017 treated set who achieved a best overall response of complete response (and/ or CRu in cohort 5) or partial response/ remission.
DOR is from first response (complete response (CR), CR unconfirmed (CRu) or partial response (PR)) to progression (PD) or death. Those without PD or death were censored at the last assessment. CR via PET-CT: Lymph/extralymph: Score 1/2/3a w/w-out resid mass, no new lesions, No FDG-avid disease in bone marrow (BM) CR via CT scan: Lymph/extralymph: Target/nodal ≤ 1.5 cm, no new lesions, normal BM CR Cohort 5: No contrast enhance, no corticosteroid, normal eye exam, neg CSF cytology CRu Cohort 5: No contrast enhance, min abnorm, normal eye exam, neg CSF cytology PR via PET-CT: Lymph/extralymph: Score 4/5b, red uptake, no new lesions, resid uptake incr, reduced in BM PR via CT scan: Lymph/extralymph: 50% decr in sum of diam ≤ 6 target/extranodal, no new/nonmeasured lesions, Organ enlarge: Spleen decr \> 50% PR Cohort 5: 50% decr in enhancing tumor, no contrast enhance, Eye exam: Minor abnorm, decr in vitreous cells/retinal infiltrate, negative, persist or suspic CSF cytology.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=24 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=20 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=7 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=4 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=8 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
3.83 Months
Interval 2.07 to 17.05
|
3.91 Months
Interval 1.87 to
Insufficient number of events to calculate upper limit of the CI using the K-M method.
|
9.07 Months
Interval 2.04 to
Insufficient number of events to calculate upper limit of the CI using the K-M method.
|
17.97 Months
Interval 17.97 to 17.97
|
17.63 Months
Interval 2.46 to 23.1
|
NA Months
Interval 2.69 to
Insufficient number of events to calculate median and upper limit of the CI using the K-M method.
|
SECONDARY outcome
Timeframe: At baseline and up until 24 months post JCAR017 infusionPopulation: All participants in the JCAR017 treated set with baseline and on-study PK measurements.
Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug. Quantitative polymerase chain reaction (qPCR) was used to determine Cmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=34 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=22 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of JCAR017 by qPCR
|
23132.1 Copies/ug
Geometric Coefficient of Variation 434.6
|
21960.0 Copies/ug
Geometric Coefficient of Variation 278.1
|
17337.8 Copies/ug
Geometric Coefficient of Variation 894.4
|
51121.0 Copies/ug
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate Geometric Coefficient of Variation.
|
7661.6 Copies/ug
Geometric Coefficient of Variation 1730.0
|
32027.1 Copies/ug
Geometric Coefficient of Variation 101.4
|
SECONDARY outcome
Timeframe: At baseline and up until 24 months post JCAR017 infusionPopulation: All participants in the JCAR017 treated set with baseline and on-study PK measurements.
Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration. Quantitative polymerase chain reaction (qPCR) was used to determine Tmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=34 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=22 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Time to Peak Concentration (Tmax) of JCAR017 by qPCR
|
11.6 Days
Interval 3.0 to 28.0
|
9.0 Days
Interval 7.0 to 14.0
|
84.1 Days
Interval 7.0 to 733.0
|
10.0 Days
Interval 10.0 to 10.0
|
9.0 Days
Interval 7.0 to 14.0
|
12.2 Days
Interval 10.0 to 21.0
|
SECONDARY outcome
Timeframe: At baseline and up until 24 months post JCAR017 infusionPopulation: All participants in the JCAR017 treated set with baseline and on-study PK measurements.
Area Under the Curve (AUC) represents the total exposure of participants to study drug. Quantitative polymerase chain reaction (qPCR) was used to determine AUC by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=34 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=22 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR
|
185586.667 Days*copies/ug
Geometric Coefficient of Variation 325.6
|
157499.362 Days*copies/ug
Geometric Coefficient of Variation 211.9
|
134819.085 Days*copies/ug
Geometric Coefficient of Variation 1268.9
|
286119.439 Days*copies/ug
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate Geometric Coefficient of Variation.
|
64945.715 Days*copies/ug
Geometric Coefficient of Variation 1345.7
|
199731.737 Days*copies/ug
Geometric Coefficient of Variation 136.8
|
SECONDARY outcome
Timeframe: At Day 29 and Months 2, 3, 6, 9, 12, 18, and 24 post JCAR017 infusion.Population: All participants in the JCAR017 treated set with baseline and on-study JCAR017 transgene results.
Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD) of 5 copies per reaction. Data obtained after the start of a new anti-cancer therapy were excluded. qPCR = Quantitative polymerase chain reaction.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=34 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=21 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Day 29
|
88.2 Percent of Participants
|
95.2 Percent of Participants
|
100.0 Percent of Participants
|
100.0 Percent of Participants
|
80.0 Percent of Participants
|
100.0 Percent of Participants
|
|
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Month 2
|
70.0 Percent of Participants
|
66.7 Percent of Participants
|
100.0 Percent of Participants
|
100.0 Percent of Participants
|
100.0 Percent of Participants
|
62.5 Percent of Participants
|
|
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Month 3
|
61.5 Percent of Participants
|
50.0 Percent of Participants
|
100.0 Percent of Participants
|
100.0 Percent of Participants
|
100.0 Percent of Participants
|
37.5 Percent of Participants
|
|
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Month 6
|
33.3 Percent of Participants
|
45.5 Percent of Participants
|
71.4 Percent of Participants
|
0.0 Percent of Participants
|
100.0 Percent of Participants
|
16.7 Percent of Participants
|
|
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Month 9
|
41.7 Percent of Participants
|
40.0 Percent of Participants
|
60.0 Percent of Participants
|
0.0 Percent of Participants
|
100.0 Percent of Participants
|
25.0 Percent of Participants
|
|
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Month 12
|
40.0 Percent of Participants
|
57.1 Percent of Participants
|
100.0 Percent of Participants
|
0.0 Percent of Participants
|
66.7 Percent of Participants
|
0.0 Percent of Participants
|
|
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Month 18
|
25.0 Percent of Participants
|
57.1 Percent of Participants
|
75.0 Percent of Participants
|
0.0 Percent of Participants
|
100.0 Percent of Participants
|
20.0 Percent of Participants
|
|
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Month 24
|
28.6 Percent of Participants
|
50.0 Percent of Participants
|
100.0 Percent of Participants
|
0.0 Percent of Participants
|
100.0 Percent of Participants
|
20.0 Percent of Participants
|
SECONDARY outcome
Timeframe: At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.Population: All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.
The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, nausea/vomiting, pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The questionnaire is scored on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The raw score is the average of the items contributing to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales higher scores indicate better QoL. For symptom scales and single items lower scores indicate fewer symptoms, i.e. better QoL. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. Only global health, fatigue, physical and cognitive functioning subscales were assessed.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=34 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=23 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Global Health Status: Change from baseline Day 1
|
-4.41 Scores on a Scale
Standard Deviation 17.070
|
-5.07 Scores on a Scale
Standard Deviation 17.898
|
-6.67 Scores on a Scale
Standard Deviation 10.244
|
-8.33 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
8.33 Scores on a Scale
Standard Deviation 25.685
|
-7.41 Scores on a Scale
Standard Deviation 12.108
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Global Health Status: Change from baseline Day 29
|
-1.26 Scores on a Scale
Standard Deviation 14.301
|
0.00 Scores on a Scale
Standard Deviation 18.002
|
-4.17 Scores on a Scale
Standard Deviation 17.236
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
16.67 Scores on a Scale
Standard Deviation 11.785
|
-1.85 Scores on a Scale
Standard Deviation 14.299
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Global Health Status: Change from baseline Day 60
|
5.00 Scores on a Scale
Standard Deviation 14.778
|
7.84 Scores on a Scale
Standard Deviation 17.547
|
4.17 Scores on a Scale
Standard Deviation 16.457
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
13.89 Scores on a Scale
Standard Deviation 26.788
|
9.26 Scores on a Scale
Standard Deviation 8.784
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Global Health Status: Change from baseline Day 90
|
2.47 Scores on a Scale
Standard Deviation 14.766
|
1.28 Scores on a Scale
Standard Deviation 22.527
|
-5.95 Scores on a Scale
Standard Deviation 17.817
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
22.22 Scores on a Scale
Standard Deviation 41.107
|
4.63 Scores on a Scale
Standard Deviation 8.448
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Global Health Status: Change from baseline Day 180
|
6.94 Scores on a Scale
Standard Deviation 13.685
|
1.04 Scores on a Scale
Standard Deviation 23.332
|
-13.10 Scores on a Scale
Standard Deviation 35.635
|
-16.67 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
25.00 Scores on a Scale
Standard Deviation 22.048
|
2.78 Scores on a Scale
Standard Deviation 8.607
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Global Health Status: Change from baseline Day 270
|
6.25 Scores on a Scale
Standard Deviation 20.140
|
9.72 Scores on a Scale
Standard Deviation 9.742
|
-3.33 Scores on a Scale
Standard Deviation 26.745
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
25.00 Scores on a Scale
Standard Deviation 22.048
|
3.33 Scores on a Scale
Standard Deviation 9.501
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Global Health Status: Change from baseline Day 365
|
-6.67 Scores on a Scale
Standard Deviation 20.337
|
3.57 Scores on a Scale
Standard Deviation 11.664
|
-12.50 Scores on a Scale
Standard Deviation 25.909
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
30.56 Scores on a Scale
Standard Deviation 26.788
|
3.33 Scores on a Scale
Standard Deviation 7.454
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Global Health Status: Change from baseline Day 545
|
-6.48 Scores on a Scale
Standard Deviation 18.530
|
3.57 Scores on a Scale
Standard Deviation 26.726
|
-5.56 Scores on a Scale
Standard Deviation 24.056
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
0.00 Scores on a Scale
Standard Deviation 47.140
|
1.67 Scores on a Scale
Standard Deviation 9.129
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Global Health Status: Change from baseline Day 730
|
-11.11 Scores on a Scale
Standard Deviation 12.975
|
-4.17 Scores on a Scale
Standard Deviation 12.638
|
-6.25 Scores on a Scale
Standard Deviation 7.979
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
20.83 Scores on a Scale
Standard Deviation 29.463
|
-2.08 Scores on a Scale
Standard Deviation 21.916
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Physical Functioning: Change from baseline Day 1
|
-3.33 Scores on a Scale
Standard Deviation 20.970
|
-6.09 Scores on a Scale
Standard Deviation 21.074
|
-3.33 Scores on a Scale
Standard Deviation 11.440
|
-6.67 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-2.67 Scores on a Scale
Standard Deviation 19.777
|
-3.70 Scores on a Scale
Standard Deviation 14.948
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Physical Functioning: Change from baseline Day 29
|
-2.63 Scores on a Scale
Standard Deviation 18.555
|
-4.21 Scores on a Scale
Standard Deviation 10.706
|
-10.00 Scores on a Scale
Standard Deviation 14.824
|
6.67 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-8.33 Scores on a Scale
Standard Deviation 16.667
|
-8.15 Scores on a Scale
Standard Deviation 18.493
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Physical Functioning: Change from baseline Day 60
|
3.11 Scores on a Scale
Standard Deviation 15.135
|
-0.39 Scores on a Scale
Standard Deviation 21.275
|
-4.44 Scores on a Scale
Standard Deviation 15.587
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-2.22 Scores on a Scale
Standard Deviation 10.184
|
-2.96 Scores on a Scale
Standard Deviation 10.062
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Physical Functioning: Change from baseline Day 90
|
3.46 Scores on a Scale
Standard Deviation 16.781
|
3.59 Scores on a Scale
Standard Deviation 12.054
|
-5.71 Scores on a Scale
Standard Deviation 11.174
|
6.67 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
11.11 Scores on a Scale
Standard Deviation 23.413
|
-0.74 Scores on a Scale
Standard Deviation 18.692
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Physical Functioning: Change from baseline Day 180
|
7.78 Scores on a Scale
Standard Deviation 12.975
|
-8.33 Scores on a Scale
Standard Deviation 31.219
|
-5.71 Scores on a Scale
Standard Deviation 19.024
|
-6.67 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
15.56 Scores on a Scale
Standard Deviation 27.756
|
-2.22 Scores on a Scale
Standard Deviation 24.825
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Physical Functioning: Change from baseline Day 270
|
3.33 Scores on a Scale
Standard Deviation 10.050
|
1.11 Scores on a Scale
Standard Deviation 19.052
|
-2.67 Scores on a Scale
Standard Deviation 22.410
|
6.67 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
24.44 Scores on a Scale
Standard Deviation 27.756
|
-6.67 Scores on a Scale
Standard Deviation 31.972
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Physical Functioning: Change from baseline Day 365
|
0.67 Scores on a Scale
Standard Deviation 16.163
|
0.95 Scores on a Scale
Standard Deviation 16.069
|
-16.67 Scores on a Scale
Standard Deviation 20.000
|
6.67 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
22.22 Scores on a Scale
Standard Deviation 26.943
|
5.33 Scores on a Scale
Standard Deviation 11.926
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Cognitive Functioning: Change from baseline Day 90
|
0.00 Scores on a Scale
Standard Deviation 13.074
|
-1.28 Scores on a Scale
Standard Deviation 12.659
|
4.76 Scores on a Scale
Standard Deviation 20.893
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
11.11 Scores on a Scale
Standard Deviation 19.245
|
0.00 Scores on a Scale
Standard Deviation 8.333
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Physical Functioning: Change from baseline Day 545
|
-3.70 Scores on a Scale
Standard Deviation 26.690
|
-1.90 Scores on a Scale
Standard Deviation 19.135
|
-13.33 Scores on a Scale
Standard Deviation 23.094
|
6.67 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
13.33 Scores on a Scale
Standard Deviation 47.140
|
9.33 Scores on a Scale
Standard Deviation 11.155
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Physical Functioning: Change from baseline Day 730
|
1.11 Scores on a Scale
Standard Deviation 15.785
|
-8.89 Scores on a Scale
Standard Deviation 28.493
|
-3.33 Scores on a Scale
Standard Deviation 8.607
|
6.67 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
3.33 Scores on a Scale
Standard Deviation 42.426
|
-3.33 Scores on a Scale
Standard Deviation 11.547
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Cognitive Functioning: Change from baseline Day 1
|
-3.43 Scores on a Scale
Standard Deviation 17.301
|
-3.62 Scores on a Scale
Standard Deviation 17.376
|
-1.67 Scores on a Scale
Standard Deviation 9.461
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-3.33 Scores on a Scale
Standard Deviation 13.944
|
-1.85 Scores on a Scale
Standard Deviation 10.015
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Cognitive Functioning: Change from baseline Day 29
|
-2.53 Scores on a Scale
Standard Deviation 16.203
|
3.51 Scores on a Scale
Standard Deviation 14.250
|
3.33 Scores on a Scale
Standard Deviation 13.147
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
8.33 Scores on a Scale
Standard Deviation 21.517
|
-7.41 Scores on a Scale
Standard Deviation 12.108
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Cognitive Functioning: Change from baseline Day 60
|
2.78 Scores on a Scale
Standard Deviation 12.444
|
0.98 Scores on a Scale
Standard Deviation 10.978
|
0.00 Scores on a Scale
Standard Deviation 27.889
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
33.33 Scores on a Scale
Standard Deviation 44.096
|
-1.85 Scores on a Scale
Standard Deviation 13.029
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Cognitive Functioning: Change from baseline Day 180
|
-2.78 Scores on a Scale
Standard Deviation 15.624
|
-2.08 Scores on a Scale
Standard Deviation 5.893
|
11.90 Scores on a Scale
Standard Deviation 20.893
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
16.67 Scores on a Scale
Standard Deviation 28.868
|
-5.56 Scores on a Scale
Standard Deviation 8.607
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Cognitive Functioning: Change from baseline Day 270
|
0.00 Scores on a Scale
Standard Deviation 22.473
|
0.00 Scores on a Scale
Standard Deviation 0.000
|
3.33 Scores on a Scale
Standard Deviation 13.944
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
33.33 Scores on a Scale
Standard Deviation 44.096
|
3.33 Scores on a Scale
Standard Deviation 7.454
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Cognitive Functioning: Change from baseline Day 365
|
-11.67 Scores on a Scale
Standard Deviation 22.292
|
0.00 Scores on a Scale
Standard Deviation 0.000
|
-4.17 Scores on a Scale
Standard Deviation 8.333
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
22.22 Scores on a Scale
Standard Deviation 38.490
|
6.67 Scores on a Scale
Standard Deviation 9.129
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Cognitive Functioning: Change from baseline Day 545
|
-7.41 Scores on a Scale
Standard Deviation 18.840
|
2.38 Scores on a Scale
Standard Deviation 11.501
|
-5.56 Scores on a Scale
Standard Deviation 19.245
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-41.67 Scores on a Scale
Standard Deviation 82.496
|
3.33 Scores on a Scale
Standard Deviation 7.454
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Cognitive Functioning: Change from baseline Day 730
|
-1.39 Scores on a Scale
Standard Deviation 18.060
|
-5.56 Scores on a Scale
Standard Deviation 8.607
|
-4.17 Scores on a Scale
Standard Deviation 15.957
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-16.67 Scores on a Scale
Standard Deviation 23.570
|
-4.17 Scores on a Scale
Standard Deviation 8.333
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Fatigue: Change from baseline Day 1
|
1.63 Scores on a Scale
Standard Deviation 26.959
|
1.45 Scores on a Scale
Standard Deviation 16.173
|
3.33 Scores on a Scale
Standard Deviation 20.320
|
0.00 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-20.00 Scores on a Scale
Standard Deviation 30.832
|
1.23 Scores on a Scale
Standard Deviation 18.794
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Fatigue: Change from baseline Day 29
|
3.03 Scores on a Scale
Standard Deviation 24.418
|
2.34 Scores on a Scale
Standard Deviation 12.046
|
5.56 Scores on a Scale
Standard Deviation 17.568
|
-11.11 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-13.89 Scores on a Scale
Standard Deviation 27.778
|
6.17 Scores on a Scale
Standard Deviation 14.815
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Fatigue: Change from baseline Day 60
|
-9.63 Scores on a Scale
Standard Deviation 18.623
|
-1.31 Scores on a Scale
Standard Deviation 20.743
|
3.70 Scores on a Scale
Standard Deviation 31.946
|
11.11 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-14.81 Scores on a Scale
Standard Deviation 35.717
|
0.00 Scores on a Scale
Standard Deviation 17.568
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Fatigue: Change from baseline Day 90
|
-4.53 Scores on a Scale
Standard Deviation 19.795
|
-4.27 Scores on a Scale
Standard Deviation 17.881
|
4.76 Scores on a Scale
Standard Deviation 35.635
|
-11.11 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-37.04 Scores on a Scale
Standard Deviation 12.830
|
-3.70 Scores on a Scale
Standard Deviation 22.906
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Fatigue: Change from baseline Day 180
|
-8.33 Scores on a Scale
Standard Deviation 21.254
|
2.78 Scores on a Scale
Standard Deviation 34.503
|
-4.76 Scores on a Scale
Standard Deviation 38.946
|
22.22 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-37.04 Scores on a Scale
Standard Deviation 23.130
|
0.00 Scores on a Scale
Standard Deviation 33.702
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Fatigue: Change from baseline Day 270
|
-9.26 Scores on a Scale
Standard Deviation 15.594
|
0.00 Scores on a Scale
Standard Deviation 22.222
|
-6.67 Scores on a Scale
Standard Deviation 14.907
|
-11.11 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-29.63 Scores on a Scale
Standard Deviation 42.066
|
-2.22 Scores on a Scale
Standard Deviation 34.605
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Fatigue: Change from baseline Day 365
|
-3.33 Scores on a Scale
Standard Deviation 14.861
|
-4.76 Scores on a Scale
Standard Deviation 20.141
|
13.89 Scores on a Scale
Standard Deviation 33.179
|
-11.11 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-44.44 Scores on a Scale
Standard Deviation 22.222
|
-13.33 Scores on a Scale
Standard Deviation 14.487
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Fatigue: Change from baseline Day 545
|
4.94 Scores on a Scale
Standard Deviation 25.526
|
-1.59 Scores on a Scale
Standard Deviation 19.698
|
-3.70 Scores on a Scale
Standard Deviation 27.962
|
-11.11 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-5.56 Scores on a Scale
Standard Deviation 23.570
|
-11.11 Scores on a Scale
Standard Deviation 15.713
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
Fatigue: Change from baseline Day 730
|
0.93 Scores on a Scale
Standard Deviation 22.947
|
3.70 Scores on a Scale
Standard Deviation 9.072
|
5.56 Scores on a Scale
Standard Deviation 14.344
|
-11.11 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-16.67 Scores on a Scale
Standard Deviation 7.857
|
-8.33 Scores on a Scale
Standard Deviation 16.667
|
SECONDARY outcome
Timeframe: At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.Population: All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.
The Functional Assessment of Cancer Treatment-Lymphoma "Additional concerns" subscale (FACT-LymS) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale was administered in this study. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. Lower scores indicate better health outcomes. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion.
Outcome measures
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=33 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=23 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=10 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=1 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=5 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=9 Participants
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
Change from baseline Day 1
|
0.7 Scores on a Scale
Standard Deviation 8.17
|
0.1 Scores on a Scale
Standard Deviation 7.05
|
1.9 Scores on a Scale
Standard Deviation 5.92
|
1.0 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-4.0 Scores on a Scale
Standard Deviation 6.52
|
-1.2 Scores on a Scale
Standard Deviation 11.08
|
|
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
Change from baseline Day 29
|
-1.7 Scores on a Scale
Standard Deviation 7.14
|
-2.7 Scores on a Scale
Standard Deviation 4.56
|
1.3 Scores on a Scale
Standard Deviation 7.24
|
-4.0 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-6.5 Scores on a Scale
Standard Deviation 8.10
|
1.0 Scores on a Scale
Standard Deviation 9.08
|
|
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
Change from baseline Day 60
|
-2.8 Scores on a Scale
Standard Deviation 5.42
|
-2.0 Scores on a Scale
Standard Deviation 4.20
|
-3.3 Scores on a Scale
Standard Deviation 9.99
|
-4.0 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-4.7 Scores on a Scale
Standard Deviation 8.33
|
-0.4 Scores on a Scale
Standard Deviation 9.95
|
|
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
Change from baseline Day 90
|
-0.4 Scores on a Scale
Standard Deviation 5.42
|
-2.8 Scores on a Scale
Standard Deviation 3.83
|
0.6 Scores on a Scale
Standard Deviation 9.25
|
-5.0 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-6.7 Scores on a Scale
Standard Deviation 8.50
|
-1.7 Scores on a Scale
Standard Deviation 8.67
|
|
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
Change from baseline Day 180
|
0.6 Scores on a Scale
Standard Deviation 5.14
|
-1.8 Scores on a Scale
Standard Deviation 5.65
|
-3.6 Scores on a Scale
Standard Deviation 10.20
|
2.0 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-8.0 Scores on a Scale
Standard Deviation 7.00
|
1.0 Scores on a Scale
Standard Deviation 7.27
|
|
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
Change from baseline Day 270
|
-0.3 Scores on a Scale
Standard Deviation 6.78
|
-3.7 Scores on a Scale
Standard Deviation 2.25
|
-1.0 Scores on a Scale
Standard Deviation 10.07
|
-8.0 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-10.00 Scores on a Scale
Standard Deviation 12.53
|
2.4 Scores on a Scale
Standard Deviation 5.22
|
|
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
Change from baseline Day 365
|
1.3 Scores on a Scale
Standard Deviation 7.01
|
-3.3 Scores on a Scale
Standard Deviation 3.30
|
2.0 Scores on a Scale
Standard Deviation 12.03
|
-6.0 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-6.7 Scores on a Scale
Standard Deviation 10.69
|
1.4 Scores on a Scale
Standard Deviation 7.33
|
|
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
Change from baseline Day 545
|
0.7 Scores on a Scale
Standard Deviation 7.14
|
-3.7 Scores on a Scale
Standard Deviation 4.35
|
-4.7 Scores on a Scale
Standard Deviation 4.16
|
-3.0 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
3.5 Scores on a Scale
Standard Deviation 6.36
|
-1.0 Scores on a Scale
Standard Deviation 4.85
|
|
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
Change from baseline Day 730
|
1.4 Scores on a Scale
Standard Deviation 7.12
|
-0.8 Scores on a Scale
Standard Deviation 1.33
|
-1.8 Scores on a Scale
Standard Deviation 5.32
|
-2.0 Scores on a Scale
Standard Deviation NA
Insufficient number of participants to calculate standard deviation.
|
-1.5 Scores on a Scale
Standard Deviation 12.02
|
-1.5 Scores on a Scale
Standard Deviation 1.29
|
Adverse Events
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
Cohort 5: Primary Central Nervous System Lymphoma
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
Serious adverse events
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=45 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=32 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=14 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=4 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=7 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=11 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.9%
4/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
General disorders
Pyrexia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Immune system disorders
Cytokine release syndrome
|
15.6%
7/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Candida sepsis
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Cellulitis
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Clostridium colitis
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Cystitis
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Device related sepsis
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Septic shock
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Staphylococcal sepsis
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Aphasia
|
8.9%
4/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Ataxia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Dyskinesia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Memory impairment
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Seizure
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Somnolence
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Stupor
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Tremor
|
11.1%
5/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Psychiatric disorders
Agitation
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Psychiatric disorders
Bradyphrenia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Psychiatric disorders
Confusional state
|
11.1%
5/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Psychiatric disorders
Delirium
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Psychiatric disorders
Disorientation
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Psychiatric disorders
Hallucination
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Vascular disorders
Capillary leak syndrome
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
Other adverse events
| Measure |
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
n=45 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
n=32 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
n=14 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
n=4 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 5: Primary Central Nervous System Lymphoma
n=7 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
n=11 participants at risk
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Acquired antithrombin III deficiency
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Anaemia
|
46.7%
21/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
25.0%
8/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
71.4%
10/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
42.9%
3/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
5/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Hypofibrinogenaemia
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
28.6%
4/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.0%
9/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
15.6%
5/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
78.6%
11/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.0%
9/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
12.5%
4/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Neutropenia
|
77.8%
35/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
68.8%
22/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
78.6%
11/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
71.4%
5/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
81.8%
9/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
35.6%
16/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
34.4%
11/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
78.6%
11/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
42.9%
3/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Eye disorders
Keratopathy
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
5/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
6.2%
2/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Constipation
|
15.6%
7/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
6.2%
2/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
7/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.4%
3/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
2/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
18.2%
2/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
6/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.4%
3/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
3/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
6.2%
2/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
2/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
General disorders
Asthenia
|
6.7%
3/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
6.2%
2/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
2/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
General disorders
Fatigue
|
6.7%
3/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
28.6%
4/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
General disorders
Oedema peripheral
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
15.6%
5/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
General disorders
Pyrexia
|
44.4%
20/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
31.2%
10/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
2/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
28.6%
2/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Immune system disorders
Cytokine release syndrome
|
26.7%
12/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
37.5%
12/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
42.9%
6/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
42.9%
3/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
13.3%
6/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.4%
3/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
28.6%
4/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
COVID-19
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Escherichia urinary tract infection
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.4%
3/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Pneumonia
|
8.9%
4/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Urinary tract infection
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
2/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Investigations
Alanine aminotransferase increased
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
28.6%
2/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
3/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
6.2%
2/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
6/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.4%
3/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.3%
6/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.7%
3/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.4%
3/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.9%
4/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
6.2%
2/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
4/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Headache
|
15.6%
7/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
12.5%
4/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Nervous system disorders
Seizure
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Psychiatric disorders
Confusional state
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.1%
1/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
4/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
14.3%
1/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
27.3%
3/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.4%
2/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
6.2%
2/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
3/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
3.1%
1/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
7.1%
1/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
|
Vascular disorders
Hypertension
|
2.2%
1/45 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
9.4%
3/32 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/14 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/7 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
0.00%
0/11 • Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER