Trial Outcomes & Findings for Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) (NCT NCT03483103)

NCT ID: NCT03483103

Last Updated: 2023-12-20

Results Overview

Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment. CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment. PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake \> mediastinum but ≤ liver; 4- uptake moderately \> liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 74 participants
• Primary outcome timeframe: From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months)
• Results posted on: 2023-12-20

Participant Flow

All efficacy and safety analyses were conducted on the JCAR017-treated Analysis Set.

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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Pre-Treatment Phase STARTED	74
Pre-Treatment Phase COMPLETED	63
Pre-Treatment Phase NOT COMPLETED	11
Treatment Phase STARTED	63
Treatment Phase Received JCAR017	61
Treatment Phase Received Nonconforming Product	1
Treatment Phase Did Not Receive Either JAR017 or Nonconforming Product	1
Treatment Phase COMPLETED	30
Treatment Phase NOT COMPLETED	33

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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Pre-Treatment Phase Other reasons	1
Pre-Treatment Phase No longer meets eligibility criteria	4
Pre-Treatment Phase Disease-related complications	1
Pre-Treatment Phase Death	5
Treatment Phase Withdrawal by Subject	7
Treatment Phase Other reasons	1
Treatment Phase Death	23
Treatment Phase Did not receive either JAR017 or nonconforming product	1
Treatment Phase Received nonconforming product	1

Baseline Characteristics

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

Baseline characteristics by cohort

Measure	Lisocabtagene Maraleucel (JCAR017) n=74 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Age, Continuous	72.8 Years STANDARD_DEVIATION 6.57 • n=5 Participants
Age, Customized < 65 years	8 Participants n=5 Participants
Age, Customized >= 65 to < 70 years	7 Participants n=5 Participants
Age, Customized >= 70 to < 75 years	27 Participants n=5 Participants
Age, Customized >= 75 years	32 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment.

CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment.

PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size.

PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=61 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Overall Response Rate (ORR)

80.3 Percent of Participants Interval 68.2 to 89.4

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

A TEAE was defined as an adverse event that started any time from initiation of product administration through and including 90 days following product administration. AEs that occurred after the initiation of subsequent anticancer therapy or product retreatment were not considered as product TEAE. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe, Grade 4= Life-threatening, and 5 = Death.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=61 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) Participants with any TEAE	59 Participants
Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) Participants with any serious TEAEs	20 Participants
Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) Participants with any Grade ≥ 3 TEAEs	48 Participants
Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) Participants with any product-related TEAE	48 Participants

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for hematology laboratory tests

Change from baseline in Hematology laboratory analysis. Includes Hemoglobin. Baseline is the last observation collected prior to or on the date of product infusion.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=59 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Change From Baseline of Hematology Laboratory Results: Hemoglobin

1.9 g/L Standard Deviation 10.05

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for hematology laboratory tests

Change from baseline in Hematology laboratory analysis. Includes Leukocytes, Lymphocytes, Neutrophils, and Platelets. Baseline is the last observation collected prior to or on the date of product infusion.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=59 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets Leukocytes	0.921 10^9 cells/L Standard Deviation 3.8562
Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets Lymphocytes	0.537 10^9 cells/L Standard Deviation 0.5953
Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets Neutrophils	-0.216 10^9 cells/L Standard Deviation 3.4010
Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets Platelets	-61.6 10^9 cells/L Standard Deviation 96.55

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

Change from baseline in Chemistry laboratory analysis. Includes Albumin. Baseline is the last observation collected prior to or on the date of product infusion.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=59 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Change From Baseline of Chemistry Laboratory Results: Albumin

3.05 g/L Standard Deviation 3.866

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

Change from baseline in Chemistry laboratory analysis. Includes Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase. Baseline is the last observation collected prior to or on the date of product infusion.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=59 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase Aspartate Aminotransferase	-3.9 U/L Standard Deviation 21.22
Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase Alanine Aminotransferase	4.6 U/L Standard Deviation 16.42
Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase Lactate Dehydrogenase	-138.2 U/L Standard Deviation 339.82

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

Change from baseline in Chemistry laboratory analysis. Includes Bilirubin, Creatinine, Direct Bilirubin, and Urate. Baseline is the last observation collected prior to or on the date of product infusion.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=59 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate Bilirubin	-0.1741 umol/L Standard Deviation 6.36075
Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate Creatinine	5.8734 umol/L Standard Deviation 21.32985
Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate Direct Bilirubin	0.0306 umol/L Standard Deviation 2.35650
Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate Urate	5.7897 umol/L Standard Deviation 93.90174

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

Change from baseline in Chemistry laboratory analysis. Includes Calcium Corrected, Magnesium, Phosphate, Potassium, and Sodium. Baseline is the last observation collected prior to or on the date of product infusion.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=59 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium Calcium Corrected	-0.0261 mmol/L Standard Deviation 0.12183
Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium Magnesium	-0.0209 mmol/L Standard Deviation 0.09292
Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium Phosphate	0.0479 mmol/L Standard Deviation 0.22624
Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium Potassium	-0.05 mmol/L Standard Deviation 0.426
Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium Sodium	1.0 mmol/L Standard Deviation 3.37

SECONDARY outcome

Timeframe: From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplant (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

Complete response rate (CRR) was defined as the percent of participants with a best overall response (BOR) of complete response (CR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment.

CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment.

PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=61 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Complete Response (CR) Rate

54.1 Percent of Participants Interval 40.8 to 66.9

SECONDARY outcome

Timeframe: From first dose to up to approximately 24 months

Population: All participants with PET positive disease who received at least one infusion of JCAR017 and achieved a response (CR or PR)

Duration of response (DOR) is defined as the time from first complete response(CR) or partial response (PR) to progressive disease (PD) or death, whichever occurred first.

CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment.

PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size.

PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=49 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Duration of Response (DOR)

23.26 Months Interval 6.24 to Insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose to up to approximately 24 months

Population: All participants with PET positive disease who received at least one infusion of JCAR017 and achieved complete response (CR)

DOR for participants with a best overall response of CR was defined as the time from documentation of first response (or CR) to progressive disease (PD) or death, whichever occurred first. The first documentation of CR/PR is the latest of all dates of required measurements to establish the response. The progression date is the earliest date of all assessments that led to a response assessment of PD.

CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment.

PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=33 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Duration of Response (DOR) in Participants With Complete Response (CR)

NA Months Interval 21.65 to Insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose to progressive disease (PD) or death (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

PFS is defined as the time from JCAR017 infusion to progressive disease (PD) or death. Kaplan-Meier (KM) methodology will be used to analyze PFS.

PD = Score 4 or 5b on the positron emission tomography 5-point scale (PET 5PS) with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=61 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Progression-Free Survival (PFS)

9.03 Months Interval 4.17 to Insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

EFS is defined as the time from JCAR017 infusion to the earliest of the following events: death from any cause, progressive disease (PD), or starting a new anticancer therapy. Kaplan-Meier (KM) methodology will be used to analyze EFS.

PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=61 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Event-Free Survival (EFS)

7.23 Months Interval 3.22 to 24.28

SECONDARY outcome

Timeframe: From first dose to date of death (up to approximately 24 months)

Population: All participants with PET positive disease who received at least one infusion of JCAR017

OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=61 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Overall Survival (OS)

NA Months Interval 16.33 to Insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose to up to 24 months

Population: All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR

Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR).

Cmax = Maximum observed blood concentration.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=55 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

PK Parameters of JCAR017 in Blood as Assessed by qPCR: Cmax

22516.3 copies/μg Geometric Coefficient of Variation 237.4

SECONDARY outcome

Timeframe: From first dose to up to 24 months

Population: All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR

Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood concentration.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=55 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

PK Parameters of JCAR017 in Blood as Assessed by qPCR: Tmax

10.0 Day Interval 6.0 to 22.0

SECONDARY outcome

Timeframe: From first dose to up to 24 months

Population: All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR

Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=55 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)

178631.0 day*copies/ug Geometric Coefficient of Variation 228.3

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Symptom scale/item higher score represents a high level of symptomatic problem.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue Subscale Baseline	36.706 Scores on a scale Standard Deviation 27.6193
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue Subscale Day 29	37.731 Scores on a scale Standard Deviation 19.9473

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Subscale Baseline	77.827 Scores on a scale Standard Deviation 24.2897
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Subscale Day 29	71.667 Scores on a scale Standard Deviation 23.8395

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Subscale Baseline	83.333 Scores on a scale Standard Deviation 17.4078
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Subscale Day 29	88.194 Scores on a scale Standard Deviation 14.9698

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health/QoL Subscale Baseline	66.815 Scores on a scale Standard Deviation 25.5491
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health/QoL Subscale Day 29	72.049 Scores on a scale Standard Deviation 18.7910

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Subscale Baseline	77.083 Scores on a scale Standard Deviation 30.4117
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Subscale Day 29	69.792 Scores on a scale Standard Deviation 28.0695

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Subscale Baseline	81.061 Scores on a scale Standard Deviation 17.1575
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Subscale Day 29	86.806 Scores on a scale Standard Deviation 13.4077

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Subscale Baseline	74.702 Scores on a scale Standard Deviation 26.3985
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Subscale Day 29	72.917 Scores on a scale Standard Deviation 25.8713

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Symptom scale/item higher score represents a high level of symptomatic problem.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain Subscale Baseline	26.488 Scores on a scale Standard Deviation 29.2631
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain Subscale Day 29	13.542 Scores on a scale Standard Deviation 22.4546

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Symptom scale/item higher score represents a high level of symptomatic problem.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea/Vomiting Subscale Baseline	5.655 Scores on a scale Standard Deviation 10.6727
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea/Vomiting Subscale Day 29	6.250 Scores on a scale Standard Deviation 14.4338

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Symptom scale/item higher score represents a high level of symptomatic problem.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation Subscale Baseline	11.905 Scores on a scale Standard Deviation 23.2931
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation Subscale Day 29	6.944 Scores on a scale Standard Deviation 13.6805

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Symptom scale/item higher score represents a high level of symptomatic problem.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea Subscale Baseline	13.690 Scores on a scale Standard Deviation 21.8135
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea Subscale Day 29	11.806 Scores on a scale Standard Deviation 21.1821

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Symptom scale/item higher score represents a high level of symptomatic problem.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia Subscale Baseline	25.595 Scores on a scale Standard Deviation 27.7005
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia Subscale Day 29	20.139 Scores on a scale Standard Deviation 27.2798

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Symptom scale/item higher score represents a high level of symptomatic problem.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea Subscale Baseline	10.714 Scores on a scale Standard Deviation 21.1843
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea Subscale Day 29	13.194 Scores on a scale Standard Deviation 17.8510

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Symptom scale/item higher score represents a high level of symptomatic problem.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss Subscale Baseline	18.788 Scores on a scale Standard Deviation 29.9270
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss Subscale Day 29	22.222 Scores on a scale Standard Deviation 28.6277

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

• Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
• 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 10-point change in the scoring is considered to be a meaningful change in HRQoL.
• Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=56 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties Subscale Baseline	13.690 Scores on a scale Standard Deviation 22.7208
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties Subscale Day 29	14.583 Scores on a scale Standard Deviation 21.6421

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=49 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale Baseline	44.22 Scores on a scale Standard Deviation 8.804
Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale Day 29	48.71 Scores on a scale Standard Deviation 6.447

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: All participants who received at least one JCAR017 infusion who completed 5-dimension measures at baseline and at least one post-baseline

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. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-5L health states ranged from -.594 for the worst (55555) to 1 for the best (11111) for UK value set with an optimal health state is assigned a score of 1.00, death is assigned a score of 0.00 and negative values representing values as worse than dead. A change of .08 is considered to be a clinically meaningful change in health utility.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=55 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Health-Related Quality of Life (HRQoL) Assessed by the EuroQol Instrument EQ-5D-5L Baseline	0.7378 Scores on a scale Standard Deviation 0.23190
Health-Related Quality of Life (HRQoL) Assessed by the EuroQol Instrument EQ-5D-5L Day 29	0.7719 Scores on a scale Standard Deviation 0.20651

SECONDARY outcome

Timeframe: From first dose after JCAR017 infusion to up to approximately 24 months

Population: All participants who received at least one infusion of JCAR017 who were monitored inpatient

The numbers of ICU inpatient days.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=41 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Numbers of Intensive Care Unit (ICU) Inpatient Days

0.0 Day Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: From first dose after JCAR017 infusion to up to approximately 24 months

Population: All participants who received at least one infusion of JCAR017 who were monitored inpatient

Number of non-ICU inpatient days.

Outcome measures

Measure

Lisocabtagene Maraleucel (JCAR017) n=41 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Numbers of Non-intensive Care Unit (ICU) Inpatient Days

14.0 Day Interval 3.0 to 34.0

SECONDARY outcome

Timeframe: From first dose after JCAR017 infusion to up to approximately 24 months

Population: All participants who received at least one infusion of JCAR017 who were monitored inpatient

Length of hospitalization stay was reported for up to 24 months post liso-cel infusion. Reasons for hospitalization include adverse events, prophylaxis, and other. Adverse events were reported for up to 90 days post liso-cel infusion.

Outcome measures

Measure	Lisocabtagene Maraleucel (JCAR017) n=41 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other Adverse Event	2 Participants
The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other Prophylaxis for CAR T-cell administration	36 Participants
The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other Other	3 Participants

Adverse Events

Lisocabtagene Maraleucel (JCAR017)

Serious events: 20 serious events

Other events: 59 other events

Deaths: 30 deaths

Serious adverse events

Measure	Lisocabtagene Maraleucel (JCAR017) n=61 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Lower gastrointestinal haemorrhage	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Obstruction gastric	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Upper gastrointestinal haemorrhage	3.3% 2/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	13.1% 8/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Bacteraemia	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 pneumonia	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Staphylococcal infection	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Stenotrophomonas sepsis	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Hip fracture	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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).
Investigations Blood bilirubin increased	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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).
Investigations Weight decreased	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	3.3% 2/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	4.9% 3/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Pulmonary embolism	3.3% 2/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	1.6% 1/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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=61 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) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
Blood and lymphatic system disorders Anaemia	31.1% 19/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	23.0% 14/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	13.1% 8/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	50.8% 31/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	29.5% 18/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	13.1% 8/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	16.4% 10/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	24.6% 15/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	8.2% 5/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	8.2% 5/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	39.3% 24/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	14.8% 9/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	8.2% 5/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	24.6% 15/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	8.2% 5/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	8.2% 5/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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).
Investigations Neutrophil count decreased	8.2% 5/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	11.5% 7/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	18.0% 11/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	18.0% 11/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Hyponatraemia	8.2% 5/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	8.2% 5/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	6.6% 4/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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% 6/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	13.1% 8/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	11.5% 7/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	6.6% 4/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	16.4% 10/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	8.2% 5/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	9.8% 6/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Depression	6.6% 4/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	13.1% 8/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Acute kidney injury	6.6% 4/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	13.1% 8/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	11.5% 7/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Productive cough	6.6% 4/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Hypertension	9.8% 6/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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	16.4% 10/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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 Orthostatic hypotension	6.6% 4/61 • Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (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: 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