Trial Outcomes & Findings for Study Evaluating the Efficacy and Safety of JCAR015 in Adult B-cell Acute Lymphoblastic Leukemia (B-ALL) (NCT NCT02535364)

NCT ID: NCT02535364

Last Updated: 2020-05-04

Results Overview

Overall remission rate (ORR) is defined as the percentage of participants with CR or CRi based on IRC assessment. For CR, all of the following must be met: (1) in bone marrow, trilineage hematopoiesis and \< 5% blasts; (2) in peripheral blood, neutrophils \> 1,000/µL, platelets \> 100,000/µL, and circulating blasts \< 1%; (3) no clinical evidence of extramedullary disease by physical examination and no symptoms suggestive of CNS involvement (if additional assessments such as CSF assessment by lumbar puncture or Ommaya reservoir tap, CNS imaging, or biopsy are performed, results must show no evidence of disease); (4) no platelet and/or neutrophil transfusions ≤ 7 days before the date of peripheral blood sampling, and (5) no clinical evidence of recurrence for 4 weeks. For CRi, all criteria for CR are met except that one or more of the following exists in the peripheral blood: neutrophils ≤ 1,000/µL, platelets ≤ 100,000/µL, or platelet transfusions ≤ 7 days before blood sampling.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 82 participants
• Primary outcome timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion
• Results posted on: 2020-05-04

Participant Flow

A total of 82 participants were enrolled at 15 study centers within the United States.

Participants were adults with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL).

Participant milestones

Measure	JCAR015 Participants received up to two intravenous (IV) infusions of JCAR015 separated by 14 to 28 days. In Part A, participants received at the Investigator's discretion, cytoreductive chemotherapy based on the Investigator's choice and/or supportive care. In Part B, eligible participants received two IV doses of JCAR015 CAR T cells. JCAR015 infusion was preceded by lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine.
Part A Screening Through Leukapheresis STARTED	82
Part A Screening Through Leukapheresis COMPLETED	57
Part A Screening Through Leukapheresis NOT COMPLETED	25
Part B Screening STARTED	57
Part B Screening COMPLETED	40
Part B Screening NOT COMPLETED	17
Study Treatment STARTED	40
Study Treatment COMPLETED	38
Study Treatment NOT COMPLETED	2
12-Month Follow-up Period STARTED	38
12-Month Follow-up Period COMPLETED	3
12-Month Follow-up Period NOT COMPLETED	35

Reasons for withdrawal

Measure	JCAR015 Participants received up to two intravenous (IV) infusions of JCAR015 separated by 14 to 28 days. In Part A, participants received at the Investigator's discretion, cytoreductive chemotherapy based on the Investigator's choice and/or supportive care. In Part B, eligible participants received two IV doses of JCAR015 CAR T cells. JCAR015 infusion was preceded by lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine.
Part A Screening Through Leukapheresis Failure to meet criteria for Part A	22
Part A Screening Through Leukapheresis Study placed on clinical hold by FDA	2
Part A Screening Through Leukapheresis Disease progression	1
Part B Screening Study placed on clinical hold by FDA	7
Part B Screening Unable to manufacture JCAR015	3
Part B Screening Death	2
Part B Screening Physician Decision	1
Part B Screening Withdrawal by Subject	1
Part B Screening Adverse Event	1
Part B Screening Change in diagnosis, no longer eligible	2
Study Treatment Death	1
Study Treatment Study placed on clinical hold by FDA	1
12-Month Follow-up Period Disease progression	22
12-Month Follow-up Period Death	5
12-Month Follow-up Period Underwent stem cell transplant	5
12-Month Follow-up Period Subject received alternative therapy	2
12-Month Follow-up Period Subject transferred to hospice	1

Baseline Characteristics

Study Evaluating the Efficacy and Safety of JCAR015 in Adult B-cell Acute Lymphoblastic Leukemia (B-ALL)

Baseline characteristics by cohort

Measure	JCAR015 n=38 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Age, Continuous	39 years n=5 Participants
Age, Customized 39 or younger	19 Participants n=5 Participants
Age, Customized 40 to 64	15 Participants n=5 Participants
Age, Customized 65 or older	4 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Time Since Diagnosis	1.8 years n=5 Participants
Number of Prior Lines of Therapy	2 lines of therapy n=5 Participants
Most Recent Prior Regimen Blinatumomab monotherapy	11 Participants n=5 Participants
Most Recent Prior Regimen Investigational agent	1 Participants n=5 Participants
Most Recent Prior Regimen Marqibo	2 Participants n=5 Participants
Most Recent Prior Regimen Multi-agent chemotherapy	15 Participants n=5 Participants
Most Recent Prior Regimen Tyrosine kinase inhibitor + chemotherapy	2 Participants n=5 Participants
Most Recent Prior Regimen Tyrosine kinase inhibitor alone	1 Participants n=5 Participants
Most Recent Prior Regimen Other	6 Participants n=5 Participants
Response to Most Recent Prior Regimen Remission	8 Participants n=5 Participants
Response to Most Recent Prior Regimen No response	27 Participants n=5 Participants
Response to Most Recent Prior Regimen Not applicable	2 Participants n=5 Participants
Response to Most Recent Prior Regimen Missing	1 Participants n=5 Participants
Prior Stem Cell Transplant Received prior stem cell transplant	14 Participants n=5 Participants
Prior Stem Cell Transplant Did not receive prior stem cell transplant	24 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Score 0	3 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Score 1	29 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Score 2	5 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Score 3	1 Participants n=5 Participants
Philadelphia Chromosome Status Philadelphia chromosome negative	34 Participants n=5 Participants
Philadelphia Chromosome Status Philadelphia chromosome positive	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one JCAR015 infusion, and who were evaluable for response (excludes 2 subjects with Grade 5 brain edema who died within 8 days after JCAR015 infusion).

Overall remission rate (ORR) is defined as the percentage of participants with CR or CRi based on IRC assessment. For CR, all of the following must be met: (1) in bone marrow, trilineage hematopoiesis and < 5% blasts; (2) in peripheral blood, neutrophils > 1,000/µL, platelets > 100,000/µL, and circulating blasts < 1%; (3) no clinical evidence of extramedullary disease by physical examination and no symptoms suggestive of CNS involvement (if additional assessments such as CSF assessment by lumbar puncture or Ommaya reservoir tap, CNS imaging, or biopsy are performed, results must show no evidence of disease); (4) no platelet and/or neutrophil transfusions ≤ 7 days before the date of peripheral blood sampling, and (5) no clinical evidence of recurrence for 4 weeks. For CRi, all criteria for CR are met except that one or more of the following exists in the peripheral blood: neutrophils ≤ 1,000/µL, platelets ≤ 100,000/µL, or platelet transfusions ≤ 7 days before blood sampling.

Outcome measures

Measure	JCAR015 n=22 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematopoietic Recovery (CRi), as Determined by an Independent Review Committee (IRC)	45.5 percentage of participants Interval 24.4 to 67.8

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes participants with morphologic disease who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one JCAR015 infusion, and who were evaluable for response (excludes 5 subjects with Grade 5 brain edema who died within 8 days after JCAR015 infusion).

ORR is defined as the percentage of participants with CR or CRi based on IRC assessment (refer to criteria in Outcome Measure #1)

Outcome measures

Measure	JCAR015 n=27 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Percentage of Participants With CR or CRi, as Determined by an IRC	55.6 percentage of participants Interval 35.3 to 74.5

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.

Best overall response (BOR) is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi).

Outcome measures

Measure	JCAR015 n=24 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC CR	8.3 percentage of participants
Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC CRi	33.3 percentage of participants

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes all participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.

BOR is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi).

Outcome measures

Measure	JCAR015 n=32 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC CR	12.5 percentage of participants
Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC CRi	34.3 percentage of participants

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.

Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a polymerase chain reaction (PCR)-based assay.

Outcome measures

Measure	JCAR015 n=24 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Percentage of Participants Who Achieved a Minimal Residual Disease (MRD)-Negative CR or CRi MRD-negative CR/CRi	41.7 percentage of participants
Percentage of Participants Who Achieved a Minimal Residual Disease (MRD)-Negative CR or CRi MRD-positive CR/CRi	0 percentage of participants
Percentage of Participants Who Achieved a Minimal Residual Disease (MRD)-Negative CR or CRi MRD-negative CR/CRi unconfirmed	12.6 percentage of participants
Percentage of Participants Who Achieved a Minimal Residual Disease (MRD)-Negative CR or CRi MRD-positive CR/CRi unconfirmed	4.2 percentage of participants

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes all participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.

Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a PCR-based assay.

Outcome measures

Measure	JCAR015 n=32 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Percentage of Participants Who Achieved a MRD-Negative CR or CRi MRD-negative CR/CRi	46.9 percentage of participants
Percentage of Participants Who Achieved a MRD-Negative CR or CRi MRD-positive CR/CRi	0 percentage of participants
Percentage of Participants Who Achieved a MRD-Negative CR or CRi MRD-negative CR/CRi unconfirmed	9.4 percentage of participants
Percentage of Participants Who Achieved a MRD-Negative CR or CRi MRD-positive CR/CRi unconfirmed	3.1 percentage of participants

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion.

RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to hematopoietic stem cell transplant (HSCT) after JCAR015 infusion were censored at the time of HSCT.

Outcome measures

Measure	JCAR015 n=10 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Relapse-Free Survival (RFS), as Determined by an IRC	6.3 months Interval 1.9 to The upper limit of the 95% confidence interval was not reached.

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion.

RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.

Outcome measures

Measure	JCAR015 n=15 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
RFS, as Determined by an IRC	4.4 months Interval 2.1 to 9.4

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.

EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.

Outcome measures

Measure	JCAR015 n=24 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Event-Free Survival (EFS)	0.03 months Interval 0.03 to 3.8

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.

EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.

Outcome measures

Measure	JCAR015 n=38 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
EFS	2.7 months Interval 0.03 to 4.2

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.

OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason.

Outcome measures

Measure	JCAR015 n=24 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Overall Survival (OS)	7.33 months Interval 5.16 to 12.68

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.

OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason.

Outcome measures

Measure	JCAR015 n=38 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
OS	8.15 months Interval 5.32 to 12.68

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion.

DOR is defined as the interval from the first documentation of CR or CRi to the earlier date of relapse or death due to ALL.

Outcome measures

Measure	JCAR015 n=15 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Duration of Remission (DOR) as Determined by an IRC	4.4 months Interval 2.1 to 9.4

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 6 months after the last JCAR015 infusion

Population: The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.

ORR at Month 6 is defined as the percentage of participants who achieved a CR or CRi at Month 6 after the final JCAR015 infusion without HSCT during the time period between the final JCAR015 infusion and the Month 6 response assessment (refer to Outcome Measure #1 for criteria for CR and CRi).

Outcome measures

Measure	JCAR015 n=32 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC, at Month 6 After the Final JCAR015 Infusion Maintained CR at Month 6	11.1 percentage of participants
Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC, at Month 6 After the Final JCAR015 Infusion Maintained CRi at Month 6	3.7 percentage of participants

SECONDARY outcome

Timeframe: Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion

Population: The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who were evaluable for response.

Percentage of participants who achieved a morphologic remission within 6 months after the final JCAR015 infusion and then proceeded to HSCT prior to 12 months after the final JCAR015 infusion

Outcome measures

Measure	JCAR015 n=27 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Percentage of Participants Who Achieved a Morphologic Remission Within 6 Months After the Final JCAR015 Infusion and Then Proceeded to HSCT	11.1 percentage of participants Interval 2.4 to 29.2

SECONDARY outcome

Timeframe: Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)

Population: The analysis population includes all participants who received at least one infusion of JCAR015.

Cmax is defined as the highest measured number of copies of JCAR015 transgene per microgram of genomic DNA in peripheral blood cells as assessed by qPCR.

Outcome measures

Measure	JCAR015 n=38 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Quantitative Polymerase Chain Reaction (qPCR)	69246 vector copy number/microgram Interval 32.0 to 408583.0

SECONDARY outcome

Timeframe: Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)

Population: The analysis population includes all participants who received at least one infusion of JCAR015.

Cmax is defined as the highest measured concentration of JCAR015 CAR T cells per microliter of peripheral blood as measured by flow cytometry.

Outcome measures

Measure	JCAR015 n=38 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Flow Cytometry	8.1 cells/microliter Interval 0.0 to 556.0

SECONDARY outcome

Timeframe: Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)

Population: The analysis population includes all participants who received at least one infusion of JCAR015.

Tmax is defined as the time after the JCAR015 infusion at which the maximum concentration (Cmax) as measured by qPCR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion.

Outcome measures

Measure	JCAR015 n=38 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Time to Maximum Concentration of JCAR015 (Tmax) in the Peripheral Blood as Measured by qPCR	8 days Interval 4.0 to 18.0

SECONDARY outcome

Timeframe: Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)

Population: The analysis population includes all participants who received at least one infusion of JCAR015 and whose Cmax was \>0.

Tmax is defined as the time after the JCAR015 infusion at which the Cmax as measured by flow cytometry of the JCAR015 CAR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion.

Outcome measures

Measure	JCAR015 n=34 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Tmax in the Peripheral Blood as Measured by Flow Cytometry	10.5 days Interval 6.0 to 29.0

SECONDARY outcome

Timeframe: Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion

Population: The analysis population includes all participants who received at least one infusion of JCAR015.

AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by qPCR of the JCAR015 transgene. AUC calculation includes pharmacokinetic (PK) results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion.

Outcome measures

Measure	JCAR015 n=38 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Area Under the Concentration-vs-Time Curve (AUC) for JCAR015 in the Peripheral Blood as Measured by qPCR	556520 vector copy number*days/microgram Interval 96.0 to 4628485.0

SECONDARY outcome

Timeframe: Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion

Population: The analysis population includes all participants who received at least one infusion of JCAR015.

AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by flow cytometry of the JCAR015 CAR. AUC calculation includes PK results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion.

Outcome measures

Measure	JCAR015 n=38 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
AUC for JCAR015 in the Peripheral Blood as Measured by Flow Cytometry	60.6 cells*days/microliter Interval 0.0 to 6806.0

SECONDARY outcome

Timeframe: Part B Screening; Day 14 after the first JCAR015 infusion; Pre-Dose Day 1 of the second JCAR015 infusion; Day 14 after the second JCAR015 infusion; and Day 28, Month 3, Month 6, and Month 12 after the last JCAR015 infusion

Population: The analysis population includes all enrolled subjects who underwent leukapheresis and had a sample that was evaluable for the assay.

Percentage of participants who developed anti-therapeutic antibodies against JCAR015

Outcome measures

Measure	JCAR015 n=41 Participants Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Percentage of Participants Who Developed Anti-Therapeutic Antibodies Against JCAR015 Day 28 after last infusion	10 percentage of participants
Percentage of Participants Who Developed Anti-Therapeutic Antibodies Against JCAR015 Month 3	64 percentage of participants
Percentage of Participants Who Developed Anti-Therapeutic Antibodies Against JCAR015 Month 6	83 percentage of participants
Percentage of Participants Who Developed Anti-Therapeutic Antibodies Against JCAR015 Month 12	22 percentage of participants

Adverse Events

JCAR015

Serious events: 23 serious events

Other events: 38 other events

Deaths: 24 deaths

Serious adverse events

Measure	JCAR015 n=38 participants at risk Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Nervous system disorders Encephalopathy	21.1% 8/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Immune system disorders Cytokine release syndrome	21.1% 8/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Brain oedema	13.2% 5/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Seizure	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Infections and infestations Sepsis	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Generalised tonic-clonic seizure	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Infections and infestations Bacteraemia	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Infections and infestations Fungaemia	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Neutropenic colitis	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Asthenia	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Pyrexia	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Blood and lymphatic system disorders Febrile neutropenia	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Cardiac disorders Atrial fibrillation	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Cardiac disorders Myocardial infarction	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Hepatobiliary disorders Cholecystitis	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Abdominal pain	2.6% 1/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.

Other adverse events

Measure	JCAR015 n=38 participants at risk Participants received up to two IV infusions of JCAR015 separated by 14 to 28 days.
Immune system disorders Cytokine release syndrome	76.3% 29/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Psychiatric disorders Confusional state	47.4% 18/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Diarrhoea	44.7% 17/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Nausea	42.1% 16/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Aphasia	39.5% 15/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Vomiting	39.5% 15/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Tremor	31.6% 12/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Headache	26.3% 10/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Metabolism and nutrition disorders Hypokalaemia	26.3% 10/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Somnolence	26.3% 10/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Blood and lymphatic system disorders Anaemia	23.7% 9/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Fatigue	23.7% 9/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Metabolism and nutrition disorders Decreased appetite	21.1% 8/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	21.1% 8/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Psychiatric disorders Insomnia	21.1% 8/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Lethargy	21.1% 8/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Musculoskeletal and connective tissue disorders Muscular weakness	21.1% 8/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Chills	18.4% 7/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations Neutrophil count decreased	18.4% 7/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Oedema peripheral	18.4% 7/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations Platelet count decreased	18.4% 7/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Seizure	18.4% 7/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Psychiatric disorders Agitation	15.8% 6/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Asthenia	15.8% 6/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Psychiatric disorders Delirium	15.8% 6/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Depressed level of consciousness	15.8% 6/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Encephalopathy	15.8% 6/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Blood and lymphatic system disorders Febrile neutropenia	15.8% 6/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Vascular disorders Hypertension	15.8% 6/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations White blood cell count decreased	15.8% 6/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Psychiatric disorders Anxiety	13.2% 5/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Constipation	13.2% 5/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Respiratory, thoracic and mediastinal disorders Cough	13.2% 5/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Metabolism and nutrition disorders Hypophosphataemia	13.2% 5/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	13.2% 5/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Pyrexia	13.2% 5/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Abdominal pain	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Musculoskeletal and connective tissue disorders Back pain	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations Blood bilirubin increased	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Dizziness	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Injury, poisoning and procedural complications Fall	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Gait disturbance	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Renal and urinary disorders Haematuria	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Psychiatric disorders Mental status changes	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Respiratory, thoracic and mediastinal disorders Oedema	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Peripheral sensory neuropathy	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Infections and infestations Pneumonia	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Skin and subcutaneous tissue disorders Pruritus	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Infections and infestations Staphylococcal infection	10.5% 4/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Abdominal distension	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Infections and infestations Candida infection	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Psychiatric disorders Depression	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Metabolism and nutrition disorders Fluid overload	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Psychiatric disorders Hallucination	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Hypoaesthesia	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Metabolism and nutrition disorders Hyponatraemia	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Vascular disorders Hypotension	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Memory impairment	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Musculoskeletal and connective tissue disorders Myalgia	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Blood and lymphatic system disorders Neutropenia	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Skin and subcutaneous tissue disorders Night sweats	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Pain	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Eye disorders Photophobia	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Cardiac disorders Sinus bradycardia	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Renal and urinary disorders Urinary incontinence	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Renal and urinary disorders Urinary retention	7.9% 3/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Abdominal discomfort	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Abdominal pain lower	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Abdominal pain upper	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Renal and urinary disorders Acute kidney injury	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations Alanine aminotransferase increased	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Skin and subcutaneous tissue disorders Alopecia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Cardiac disorders Angina pectoris	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Respiratory, thoracic and mediastinal disorders Aspiration	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Ataxia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations Blood alkaline phosphatase increased	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations Blood bicarbonate decreased	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations Blood creatinine increased	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations Blood fibrinogen decreased	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Cardiac disorders Bradycardia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Catheter site pain	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Infections and infestations Cellulitis	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Chest discomfort	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Vascular disorders Deep vein thrombosis	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Dry mouth	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Skin and subcutaneous tissue disorders Dry skin	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Dyspepsia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Dysphagia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Ear and labyrinth disorders Ear pain	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Faecal incontinence	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Vascular disorders Haematoma	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Haemorrhoids	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Respiratory, thoracic and mediastinal disorders Hiccups	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Metabolism and nutrition disorders Hypernatraemia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Metabolism and nutrition disorders Hyperuricaemia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Metabolism and nutrition disorders Hypophagia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations International normalised ratio increased	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Injury, poisoning and procedural complications Laceration	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Investigations Lymphocyte count decreased	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Malaise	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Migraine	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Mucosal inflammation	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Myoclonus	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Neuropathy peripheral	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Nervous system disorders Paraesthesia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
General disorders Peripheral swelling	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Skin and subcutaneous tissue disorders Rash pruritic	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Gastrointestinal disorders Retching	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Cardiac disorders Tachycardia	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.
Respiratory, thoracic and mediastinal disorders Tachypnoea	5.3% 2/38 • From the time of the first JCAR015 infusion up to 12 months after the last JCAR015 infusion The summary tables include treatment-emergent adverse events, defined as adverse events that (1) occurred or worsened after the first JCAR015 infusion and up to 30 days after the final JCAR015 infusion or (2) led to JCAR015 discontinuation. Adverse events occurring after the initiation of another anticancer therapy were not considered as treatment-emergent adverse events.

Additional Information

Dr. Nikolaus Trede

Juno Therapeutics

Phone: 206-566-5886

Email: Nick.Trede@junotherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigators have the right to publish and/or present study data after publication of the sponsor's multicenter study publication provided that the investigator shall (i) provide the sponsor a copy of any proposed publication or presentation generally thirty (30) days in advance of the submission; (ii) delete any confidential information of the sponsor; and (iii) delay submission for generally up to ninety (90) days to permit the sponsor to prepare and file intellectual property applications.
• Publication restrictions are in place

Restriction type: OTHER