Trial Outcomes & Findings for Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies (NCT NCT02706392)
NCT ID: NCT02706392
Last Updated: 2022-08-31
Results Overview
Will be graded according to Common Terminology Criteria for Adverse Events. Outcome will be reported as a count of participants that experienced adverse events in each arm.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
Within 35 days of receptor tyrosine kinase-like orphan receptor 1 positive chimeric antigen receptor-T cell infusion
Results posted on
2022-08-31
Participant Flow
Participant milestones
| Measure |
Cohort A Dose Level 1
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
2
|
3
|
11
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
1
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
2
|
5
|
2
|
Reasons for withdrawal
| Measure |
Cohort A Dose Level 1
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
2
|
2
|
5
|
2
|
Baseline Characteristics
Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies
Baseline characteristics by cohort
| Measure |
Cohort A Dose Level 1
n=2 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
n=1 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
n=3 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
n=11 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
2 participants
n=10 Participants
|
21 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Within 35 days of receptor tyrosine kinase-like orphan receptor 1 positive chimeric antigen receptor-T cell infusionWill be graded according to Common Terminology Criteria for Adverse Events. Outcome will be reported as a count of participants that experienced adverse events in each arm.
Outcome measures
| Measure |
Cohort A Dose Level 1
n=2 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
n=1 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
n=3 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
n=11 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Number of Participants That Experienced Adverse Events
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after the T cell infusionPopulation: Number analyzed is the number of participants that were evaluated for persistence in each arm. 2 patients were excluded because they went off study before their 1 month post treatment evaluation and were not assessed for persistence. 1 of these patients was in cohort A DL2. The other was in Cohort B DL4.
Data should be collected for persistence of transferred T cells and descriptive statistics will be used to summarize the changes from baseline where possible. This outcome is reported as a count of participants who experienced persistence at Day 28.
Outcome measures
| Measure |
Cohort A Dose Level 1
n=2 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
n=3 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
n=11 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
n=1 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Number of Participants With Persistence of Adoptively Transferred Receptor Tyrosine Kinase-like Orphan Receptor 1 Positive Chimeric Antigen Receptor-T Cells
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 48 days post infusionPopulation: Participants were analyzed if there was a biopsy done within 48 days post infusion. Biopsies were performed on 10 participants total, 2 participants in Cohort A and 8 participants in Cohort B.
Samples of bone marrow, blood and other tissues (e.g. cerebral spinal fluid, tumor, thoracentesis fluid) will be collected from patients as clinically indicated. CD3 T-cells and their frequency/persistence will be detected by flow cytometry, polymerase chain reaction, and immunohistochemistry as appropriate. This outcome is reported as a count of participants who had detectable CD3 T-cells in their biopsy sample. The patients in Cohort A had a biopsy of their bone marrow. For the patients in Cohort B, biopsy location was dependent on site of disease per patient.
Outcome measures
| Measure |
Cohort A Dose Level 1
n=2 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
n=3 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
n=3 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Number of Participants Biopsied With Detectable CD3 T-cells
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: In arm 1, one patient was not assessed for a response and therefore is not included in the "number of participants analyzed" count.
Outcome will be reported as a count of participants in each arm that experienced complete remission and/or partial remission. For Patients with Acute lymphoblast leukemia (ALL), remission status will be determined by restaging of bone marrow and other involved sites by morphology, flow cytometry and molecular studies, as appropriate. For Patients with NSCLC and TNBC, tumor response and progression will be evaluated in this study using the international criteria proposed by RECIST Criteria. Target lesion responses will be described as (1) Complete response (CR): disappearance of all target lesions; (2) Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and, (4) Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD.
Outcome measures
| Measure |
Cohort A Dose Level 1
n=1 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
n=1 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
n=3 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
n=11 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Objective Response Rate of Complete Remission and Partial Remission
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Only participants that survived up to 1 year post-infusion (per patient) could be analyzed for this outcome. In arm 1, one patient survived up to 1 year but they were not assessed for a response, therefore are not included in the "number of participants analyzed" count.
Outcome will be reported as a count of participants in each arm that survived up to 1 year post-infusion (per patient) and did not progress. For patients with Acute lymphoblast leukemia (ALL), remission status will be determined by restaging of bone marrow and other involved sites by morphology, flow cytometry and molecular studies, as appropriate. For Patients with NSCLC and TNBC, tumor response and progression will be evaluated in this study using the international criteria proposed by RECIST Criteria. Target lesion responses will be described as (1) Complete response (CR): disappearance of all target lesions; (2) Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and, (4) Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD.
Outcome measures
| Measure |
Cohort A Dose Level 1
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
n=1 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
n=1 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
n=6 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Progression Free Survival
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearData should be collected for efficacy of transferred T cells and descriptive statistics will be used to summarize the changes from baseline where possible. Outcome will be reported as a count of participants that survived up until the 1 year post-infusion (per patient) timepoint.
Outcome measures
| Measure |
Cohort A Dose Level 1
n=2 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
n=1 Participants
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
n=3 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
n=11 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
n=2 Participants
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
Adverse Events
Cohort A Dose Level 1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort A Dose Level 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B Dose Level 1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Cohort B Dose Level 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort B Dose Level 3
Serious events: 10 serious events
Other events: 11 other events
Deaths: 5 deaths
Cohort B Dose Level 4
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort A Dose Level 1
n=2 participants at risk
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
n=1 participants at risk
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
n=2 participants at risk
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
n=3 participants at risk
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
n=11 participants at risk
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
n=2 participants at risk
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
General disorders
Fever
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
66.7%
2/3 • Number of events 3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
81.8%
9/11 • Number of events 12 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
2/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
18.2%
2/11 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
2/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
18.2%
2/11 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
Other adverse events
| Measure |
Cohort A Dose Level 1
n=2 participants at risk
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort A Dose Level 2
n=1 participants at risk
Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 1
n=2 participants at risk
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study.
|
Cohort B Dose Level 2
n=3 participants at risk
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 3
n=11 participants at risk
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg.
|
Cohort B Dose Level 4
n=2 participants at risk
Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
66.7%
2/3 • Number of events 3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
45.5%
5/11 • Number of events 6 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
36.4%
4/11 • Number of events 4 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
18.2%
2/11 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
General disorders
Edema limbs
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
18.2%
2/11 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Infections and infestations
Lung infection
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
100.0%
2/2 • Number of events 15 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
18.2%
2/11 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
2/2 • Number of events 3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
3/3 • Number of events 6 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
11/11 • Number of events 13 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 4 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Investigations
Neutrophil count decreased
|
100.0%
2/2 • Number of events 3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 4 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
2/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
3/3 • Number of events 6 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
11/11 • Number of events 11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Investigations
Platelet count decreased
|
100.0%
2/2 • Number of events 4 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
36.4%
4/11 • Number of events 4 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Investigations
White blood cell decreased
|
100.0%
2/2 • Number of events 4 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
2/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
3/3 • Number of events 6 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
11/11 • Number of events 12 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
27.3%
3/11 • Number of events 3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
45.5%
5/11 • Number of events 5 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/11 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
36.4%
4/11 • Number of events 4 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
18.2%
2/11 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
100.0%
1/1 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/3 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
18.2%
2/11 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
0.00%
0/2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
33.3%
1/3 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
9.1%
1/11 • Number of events 1 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
50.0%
1/2 • Number of events 2 • Up to one year following last infusion per patient
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place