Trial Outcomes & Findings for A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007) (NCT NCT03744676)

NCT ID: NCT03744676

Last Updated: 2025-02-27

Results Overview

Cytokine release syndrome is characterized by high fever, fatigue, nausea, headache, dyspnea, tachycardia, rigors, hypotension, hypoxia, myalgia/arthralgia, and anorexia. Incidence of Grade ≥ 3 CRS, based on the TEAE with MedDRA PT "Cytokine release syndrome," graded according to the grading scale adapted from Lee (Lee 2014).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 104 participants
• Primary outcome timeframe: From first dose to 90 days following first dose (up to approximately 90 days)
• Results posted on: 2025-02-27

Participant Flow

Participant milestones

Measure	Lisocabtagene Maraleucel (JCAR017) Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Pre-Treatment Phase STARTED	104
Pre-Treatment Phase COMPLETED	84
Pre-Treatment Phase NOT COMPLETED	20
Treatment Phase STARTED	82
Treatment Phase Participants Who Received LDC and Non Conforming Product	1
Treatment Phase COMPLETED	35
Treatment Phase NOT COMPLETED	47

Reasons for withdrawal

Measure	Lisocabtagene Maraleucel (JCAR017) Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Pre-Treatment Phase Disease related complications	2
Pre-Treatment Phase No longer meets study criteria	4
Pre-Treatment Phase Death	7
Pre-Treatment Phase Other Reasons	7
Treatment Phase Participant withdrew consent	8
Treatment Phase Death	33
Treatment Phase other reasons	6

Baseline Characteristics

A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

Baseline characteristics by cohort

Measure	Lisocabtagene Maraleucel (JCAR017) n=104 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Age, Continuous	64.9 Years STANDARD_DEVIATION 11.61 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Race/Ethnicity, Customized White	88 Participants n=5 Participants
Race/Ethnicity, Customized Other	7 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to 90 days following first dose (up to approximately 90 days)

Population: All participants who received at least one JCAR017 infusion

Cytokine release syndrome is characterized by high fever, fatigue, nausea, headache, dyspnea, tachycardia, rigors, hypotension, hypoxia, myalgia/arthralgia, and anorexia.

Incidence of Grade ≥ 3 CRS, based on the TEAE with MedDRA PT "Cytokine release syndrome," graded according to the grading scale adapted from Lee (Lee 2014).

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Percentage of Participants With Cytokine Release Syndrome (CRS) Adverse Events Grade ≥ 3

0.0 Percentage of participants Interval 0.0 to 4.4

PRIMARY outcome

Timeframe: From first dose to 90 days following first dose (up to approximately 90 days)

Population: All participants who received at least one JCAR017 infusion

NT events have also been reported and may include neurologic symptoms such as altered mental status, aphasia, altered level of consciousness, and seizures or seizure-like activity.

Incidence of Grade ≥ 3 NT, defined as an Investigator-identified TEAE considered neurotoxicity related to JCAR017.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Percentage of Participants With Neurotoxicity (NT) Adverse Events Grade ≥ 3

9.8 Percentage of participants Interval 4.3 to 18.3

PRIMARY outcome

Timeframe: From first dose to 90 days following first dose (up to approximately 90 days)

Population: All participants who received at least one JCAR017 infusion

Incidence of treatment-emergent Grade ≥ 3 infections, defined using MedDRA SOC.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Percentage of Participants With Infection Adverse Events Grade ≥ 3

11.0 Percentage of participants Interval 5.1 to 19.8

PRIMARY outcome

Timeframe: At Day 29 after first treatment

Population: All participants who received at least one JCAR017 infusion

Prolonged cytopenia is defined as the occurrence of Grade ≥ 3 cytopenia not resolved by the Day 29 visit, based on laboratory results of low hemoglobin, absolute neutrophil count decreased, and platelet count decreased. The frequency of subjects experiencing each individual laboratory abnormality and the total number with at least 1 abnormality will be summarized, as will recovery from prolonged cytopenia after Day 29.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Percentage of Participants With Grade ≥ 3 Prolonged Cytopenia at Day 29.

32.9 Percentage of participants Interval 22.9 to 44.2

SECONDARY outcome

Timeframe: From first dose to 90 days following first dose (up to approximately 90 days)

Population: All participants who received at least one JCAR017 infusion

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Number of Participants With Adverse Events

82 Participants

SECONDARY outcome

Timeframe: From first dose to up to 41 months

Population: All participants who received at least one JCAR017 infusion

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Number of Participants With Clinically Significant Laboratory Abnormalities- Hematology

0 Participants

SECONDARY outcome

Timeframe: From first dose to up to 41 months

Population: All participants who received at least one JCAR017 infusion

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Number of Participants With Clinically Significant Laboratory Abnormalities- Chemistry

0 Participants

SECONDARY outcome

Timeframe: From first dose to 90 days following first dose (up to approximately 90 days)

Population: All participants who received at least one JCAR017 infusion

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Number of Participants With Adverse Events Grade ≥ 3

61 Participants

SECONDARY outcome

Timeframe: From first dose to up to approximately 41 months

Population: All participants who received at least one JCAR017 infusion

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Time to Onset and Time to Resolution of Grade ≥ 3 Cytokine Release Syndrome (CRS) Time to Onset	0 Days Interval 0.0 to 0.0
Time to Onset and Time to Resolution of Grade ≥ 3 Cytokine Release Syndrome (CRS) Time to Resolution	0 Days Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From first dose to up to approximately 41 months

Population: All participants who received at least one JCAR017 infusion

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Time to Onset and Time to Resolution of Grade ≥ 3 Neurotoxicity (NT) Time to Onset	9.5 Days Interval 3.0 to 33.0
Time to Onset and Time to Resolution of Grade ≥ 3 Neurotoxicity (NT) Time to Resolution	16.5 Days Interval 5.0 to 47.0

SECONDARY outcome

Timeframe: From first dose to up to approximately 41 months

Population: All participants who received at least one JCAR017 infusion

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Number of Participants Administered Tocilizumab and Corticosteroid for Management of Cytokine Release Syndrome (CRS) Tocilizumab Only	7 Participants
Number of Participants Administered Tocilizumab and Corticosteroid for Management of Cytokine Release Syndrome (CRS) Corticosteroid Only	2 Participants
Number of Participants Administered Tocilizumab and Corticosteroid for Management of Cytokine Release Syndrome (CRS) Both Tocilizumab and Corticosteroid	7 Participants

SECONDARY outcome

Timeframe: From first dose to up to study completion (Approximately 57 Months and 24 days)

Population: All participants who received at least one JCAR017 infusion

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Number of Participants Administered Tocilizumab and Corticosteroid for Management of Neurotoxicity (NT) Corticosteroid Only	12 Participants
Number of Participants Administered Tocilizumab and Corticosteroid for Management of Neurotoxicity (NT) Tocilizumab Only	0 Participants
Number of Participants Administered Tocilizumab and Corticosteroid for Management of Neurotoxicity (NT) Both Tocilizumab and Corticosteroid	1 Participants

SECONDARY outcome

Timeframe: From first dose to up to approximately 41 months

Population: All participants who received at least one JCAR017 infusion

The Percentage of participants with a best overall response (BOR) of either CR or PR based on the Lugano 2014 criteria.

Disease response will be determined according to the "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification"

Complete response is defined as:

1. Score 1, 2, or 3a with or without residual mass

2. No evidence of FDG-avid disease in marrow

Partial Response is defined as:

1. Score 4 or 5a with reduced uptake compared with baseline and residual masses of any size

2. Bone marrow with residual uptake higher than in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in marrow in the context of a nodal response, should consider further evaluation with MRI, biopsy, or interval scan.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Objective Response Rate (ORR)

80.5 Percentage of Participants Interval 70.3 to 88.4

SECONDARY outcome

Timeframe: From first dose to up to approximately 41 months

Population: All participants who received at least one JCAR017 infusion

The Percentage of participants with a best overall response (BOR) with CR based on the Lugano 2014 criteria.

Disease response will be determined according to the "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification"

Complete response is defined as:

1. Score 1, 2, or 3a with or without residual mass

2. No evidence of FDG-avid disease in marrow

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Complete Response Rate (CRR)

53.7 Percentage of Participants Interval 42.3 to 64.7

SECONDARY outcome

Timeframe: From first dose to up to approximately 41 months

Population: All participants who received at least one JCAR017 infusion

Duration of response (DOR) is defined as the time from the first documentation of response (CR or PR) after JCAR017 infusion to disease progression or death from any cause, whichever occurs first.

Duration of response (DOR) if BOR is CR is defined for subjects with a BOR of CR as the time from the first documentation of response (CR or PR) after JCAR017 infusion to earlier of disease progression or death from any cause.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Duration of Response (DoR) and Duration of Complete Response (DoCR) DoR	14.75 Months Interval 5.03 to Insufficient number of participants with a response to reach upper limit number according to KM methodology.
Duration of Response (DoR) and Duration of Complete Response (DoCR) DoCR	NA Months Interval 16.59 to Insufficient number of participants with a response to reach median upper limit number according to KM methodology.

SECONDARY outcome

Timeframe: From first dose to up to study completion (Approximately 57 Months and 24 days)

Population: All participants who received at least one JCAR017 infusion

Progression-free survival is defined as the time from infusion of JCAR017 to progressive disease or death, whichever is earlier. If a subject does not have an event for the PFS analysis, the subject will be censored.

Progressive Disease is defined as:

1. Score 4 or 5a with an increase in intensity of uptake from nadir

2. New FDG-avid foci consistent with lymphoma (may need biopsy or repeat scan if uncertain about etiology of foci).

3. Investigator assessed clinical progression

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Progression Free Survival (PFS)

5.86 Months Interval 0.7 to 26.7

SECONDARY outcome

Timeframe: From first dose to up to study completion (Approximately 57 Months and 24 days)

Population: All participants who received at least one JCAR017 infusion

Overall survival is defined as the time from infusion of JCAR017 to the date of death. For assessment of OS, data from surviving participants will be censored at the last time that the participant is known to be alive. The OS analysis will include all available survival information from the long-term follow-up study if applicable.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Overall Survival (OS)

21.88 Months Interval 1.0 to 50.1

SECONDARY outcome

Timeframe: 28days after first dose

Population: qPCR PK Analysis Set

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=81 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Area Under the Blood Concentration-time Curve From Time to Zero to 28 Days After Dosing AUC (0-28)

219760.3 day*copies/μg Geometric Coefficient of Variation 216.1

SECONDARY outcome

Timeframe: 28days after first dose

Population: qPCR PK Analysis Set

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=81 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Maximum Observed Blood Concentration (Cmax)

24077.8 copies/μg Geometric Coefficient of Variation 230.7

SECONDARY outcome

Timeframe: 28days after first dose

Population: qPCR PK Analysis Set

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=81 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Time of Maximum Observed Blood Concentration (Tmax)

10.0 days Interval 7.0 to 28.0

SECONDARY outcome

Timeframe: From Enrollment to end of follow up, approximately 26 months

Population: JCAR017 All treated participants with a measurement at post dose month 24

The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/HRQoL represents a high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatic problem.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=22 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Apptetie Loss	-22.7 Scores on a Scale Standard Deviation 23.87
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Cognitive Functioning	1.5 Scores on a Scale Standard Deviation 18.48
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Constipation	-7.6 Scores on a Scale Standard Deviation 27.08
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Diarrhea	-3.0 Scores on a Scale Standard Deviation 27.04
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Dyspnea	6.1 Scores on a Scale Standard Deviation 13.16
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Emotional Functioning	2.7 Scores on a Scale Standard Deviation 20.31
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Fatigue	-14.6 Scores on a Scale Standard Deviation 21.24
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Financial Difficulties	-9.1 Scores on a Scale Standard Deviation 25.58
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Stuats/QoL	15.2 Scores on a Scale Standard Deviation 21.61
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Insomnia	-10.6 Scores on a Scale Standard Deviation 27.96
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Nausea and Vomiting	-9.8 Scores on a Scale Standard Deviation 17.56
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Pain	-13.6 Scores on a Scale Standard Deviation 26.55
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Physical Functioning	2.4 Scores on a Scale Standard Deviation 16.14
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Role Functioning	12.9 Scores on a Scale Standard Deviation 23.53
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Social Functioning	17.4 Scores on a Scale Standard Deviation 24.92

SECONDARY outcome

Timeframe: Post Dose Month 24

Population: All treated participants with an EQ-5D-5L index score post dose month 24

The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=21 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Mean Change From Baseline in EuroQol Instrument EQ-5D-5L.

0.0 Score on a Scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: From first hospitalization to the last. Approximately 31 days

Population: Liso-cel-treated Analysis Set - Inpatient Monitored

Length of initial ICU and non-ICU stay from liso-cel administration

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=25 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Number of Intensive Care Unit (ICU) Inpatient Days and Non-ICU Inpatient Days and Reasons for Hospitalization Initial ICU Stay	5.5 days Interval 4.0 to 7.0
Number of Intensive Care Unit (ICU) Inpatient Days and Non-ICU Inpatient Days and Reasons for Hospitalization Initial Non-ICU Stay	15.0 days Interval 0.0 to 31.0

SECONDARY outcome

Timeframe: From first dose to end of treatment period approximately 24 months

Number of participants who received transfusions

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Number of Participants Who Received Transfusions

43 Participants

SECONDARY outcome

Timeframe: From first dose to end of treatment period approximately 24 months

Growth factor support was defined as concomitant administration of FILGRASTIM, TBO FILGRASTIM, PEGFILGRASTIM, FILGRASTIM SNDZ, or FILGRASTIM AAFI.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Number of Participants Requiring Growth Factor Support.

35 Participants

SECONDARY outcome

Timeframe: From first dose to end of treatment period approximately 24 months

Number of participants requiring intravenous immunoglobulin (IVIG) support

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=82 Participants Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Number of Participants Requiring Intravenous Immunoglobulin (IVIG) Support

12 Participants

Adverse Events

Lisocabtagene Maraleucel (JCAR017)

Serious events: 48 serious events

Other events: 82 other events

Deaths: 48 deaths

Serious adverse events

Measure	Lisocabtagene Maraleucel (JCAR017) n=82 participants at risk Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Blood and lymphatic system disorders Febrile neutropenia	6.1% 5/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Blood and lymphatic system disorders Neutropenia	2.4% 2/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Cardiac disorders Atrial fibrillation	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Cardiac disorders Sinus tachycardia	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Cardiac disorders Supraventricular tachycardia	2.4% 2/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Ear and labyrinth disorders Vertigo	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Eye disorders Vision blurred	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Abdominal pain	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Abdominal pain lower	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Diarrhoea	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Large intestine perforation	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Small intestinal obstruction	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
General disorders Gait disturbance	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
General disorders Pyrexia	4.9% 4/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Immune system disorders Cytokine release syndrome	29.3% 24/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Infections and infestations Atypical pneumonia	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Infections and infestations COVID-19	2.4% 2/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Infections and infestations Clostridium difficile colitis	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Infections and infestations Cytomegalovirus viraemia	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Infections and infestations Pneumonia	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Infections and infestations Sepsis	6.1% 5/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Infections and infestations Urinary tract infection	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Infections and infestations Urosepsis	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Metabolism and nutrition disorders Dehydration	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Metabolism and nutrition disorders Failure to thrive	2.4% 2/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Metabolism and nutrition disorders Hypercalcaemia	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Metabolism and nutrition disorders Lactic acidosis	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Musculoskeletal and connective tissue disorders Bone pain	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Musculoskeletal and connective tissue disorders Flank pain	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Musculoskeletal and connective tissue disorders Muscular weakness	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Musculoskeletal and connective tissue disorders Neck pain	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Aphasia	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Cognitive disorder	4.9% 4/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Demyelinating polyneuropathy	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Depressed level of consciousness	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Disturbance in attention	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Dizziness	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Encephalopathy	4.9% 4/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Headache	3.7% 3/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Memory impairment	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Seizure	2.4% 2/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Slow speech	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Somnolence	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Tremor	4.9% 4/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Psychiatric disorders Agitation	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Psychiatric disorders Anxiety	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Psychiatric disorders Confusional state	2.4% 2/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Psychiatric disorders Delirium	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Psychiatric disorders Disorientation	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Psychiatric disorders Hallucination, visual	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Psychiatric disorders Mental status changes	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Renal and urinary disorders Hydronephrosis	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Renal and urinary disorders Urinary retention	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Vascular disorders Hypotension	1.2% 1/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).

Other adverse events

Measure	Lisocabtagene Maraleucel (JCAR017) n=82 participants at risk Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Blood and lymphatic system disorders Anaemia	34.1% 28/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Blood and lymphatic system disorders Leukopenia	43.9% 36/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Blood and lymphatic system disorders Lymphopenia	20.7% 17/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Blood and lymphatic system disorders Neutropenia	67.1% 55/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Blood and lymphatic system disorders Thrombocytopenia	35.4% 29/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Abdominal pain	8.5% 7/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Constipation	23.2% 19/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Diarrhoea	23.2% 19/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Nausea	25.6% 21/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Gastrointestinal disorders Vomiting	9.8% 8/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
General disorders Asthenia	11.0% 9/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
General disorders Fatigue	30.5% 25/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
General disorders Oedema peripheral	12.2% 10/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
General disorders Pyrexia	14.6% 12/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Immune system disorders Cytokine release syndrome	12.2% 10/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Immune system disorders Hypogammaglobulinaemia	8.5% 7/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Injury, poisoning and procedural complications Fall	6.1% 5/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Metabolism and nutrition disorders Decreased appetite	23.2% 19/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Metabolism and nutrition disorders Dehydration	8.5% 7/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Metabolism and nutrition disorders Hypokalaemia	13.4% 11/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Metabolism and nutrition disorders Hypomagnesaemia	7.3% 6/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Metabolism and nutrition disorders Hypophosphataemia	9.8% 8/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Musculoskeletal and connective tissue disorders Arthralgia	19.5% 16/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Musculoskeletal and connective tissue disorders Back pain	13.4% 11/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Musculoskeletal and connective tissue disorders Bone pain	6.1% 5/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Musculoskeletal and connective tissue disorders Pain in extremity	9.8% 8/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Dizziness	15.9% 13/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Headache	24.4% 20/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Lethargy	7.3% 6/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Nervous system disorders Tremor	9.8% 8/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Psychiatric disorders Agitation	6.1% 5/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Psychiatric disorders Insomnia	11.0% 9/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Respiratory, thoracic and mediastinal disorders Cough	11.0% 9/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.3% 6/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.2% 10/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Skin and subcutaneous tissue disorders Pruritus	11.0% 9/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Skin and subcutaneous tissue disorders Rash	8.5% 7/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
Vascular disorders Hypotension	12.2% 10/82 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 57 months and 24 days). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days). The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: 1-855-907-3286

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER