Trial Outcomes & Findings for A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (NCT NCT03575351)

Last Updated: 2025-08-03

Results Overview

Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

184 participants

Primary outcome timeframe

From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)

Results posted on

2025-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care Arm 3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin \[R-DHAP\], rituximab, ifosfamide, carboplatin and etoposide \[R-ICE\], rituximab, gemcitabine, dexamethasone, and cisplatin \[R-GDP\]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks	Liso-cel Arm \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
Overall Study STARTED	92	92
Overall Study Treated	91	90
Overall Study Crossover	61	0
Overall Study Received JCAR017 Conforming Cell Product	57	89
Overall Study Received JCAR017 Nonconforming Cell Product	1	1
Overall Study COMPLETED	37	81
Overall Study NOT COMPLETED	55	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care Arm 3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin \[R-DHAP\], rituximab, ifosfamide, carboplatin and etoposide \[R-ICE\], rituximab, gemcitabine, dexamethasone, and cisplatin \[R-GDP\]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks	Liso-cel Arm \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
Overall Study Adverse Event	1	0
Overall Study Death	2	2
Overall Study Death due to the COVID-19 pandemic	0	1
Overall Study Lack of Efficacy	28	0
Overall Study Withdrawal by Subject	1	1
Overall Study Physician Decision	3	0
Overall Study Disease relapse	15	6
Overall Study Study drug manufacturing failure	0	1
Overall Study other reasons	5	0

Baseline Characteristics

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin \[R-DHAP\], rituximab, ifosfamide, carboplatin and etoposide \[R-ICE\], rituximab, gemcitabine, dexamethasone, and cisplatin \[R-GDP\]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Total n=184 Participants Total of all reporting groups
Age, Continuous	54.2 Years STANDARD_DEVIATION 13.94 • n=5 Participants	58.3 Years STANDARD_DEVIATION 12.61 • n=7 Participants	56.3 Years STANDARD_DEVIATION 13.41 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	48 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	44 Participants n=7 Participants	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants	65 Participants n=7 Participants	127 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	55 Participants n=5 Participants	54 Participants n=7 Participants	109 Participants n=5 Participants
Race/Ethnicity, Customized Not Collected or Reported	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Event-free Survival (EFS) Per Independent Review Committee (IRC)	29.5 Months Interval 9.5 to Upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.	2.4 Months Interval 2.2 to 4.9

SECONDARY outcome

Timeframe: From randomization up to 3 years post randomization (Up to 36 months)

Population: All randomized participants

Complete response rate (CRR) is defined as the percentage of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Complete Response Rate (CRR)	73.9 Percentage of participants Interval 63.7 to 82.5	43.5 Percentage of participants Interval 33.2 to 54.2

SECONDARY outcome

Timeframe: From randomization up to 3 years post randomization (Up to 36 months)

Population: All randomized participants

The number of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Number of Participants With Complete Response (CR)	68 Participants	40 Participants

SECONDARY outcome

Timeframe: From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)

Population: All randomized participants

Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Progression-free Survival (PFS)	NA Months Interval 12.6 to Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.	6.2 Months Interval 4.3 to 8.6

SECONDARY outcome

Timeframe: From randomization to time of death due to any cause (Up to 36 months)

Population: All randomized participants

Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Overall Survival (OS)	NA Months Interval 42.8 to Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.	NA Months Interval 18.2 to Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.

SECONDARY outcome

Timeframe: From randomization to PR or CR (Up to 36 months)

Population: All randomized participants

ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Overall Response Rate (ORR)	87.0 Percentage of participants Interval 78.3 to 93.1	48.9 Percentage of participants Interval 38.3 to 59.6

SECONDARY outcome

Timeframe: From randomization to to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first (Up to 36 months)

Population: All randomized participants with PR or CR

DoR is defined as the time from first partial or complete response (CR or PR) to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=80 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=45 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Duration of Response (DoR) Per Independent Review Committee (IRC)	NA Months Interval 16.9 to Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.	9.1 Months Interval 5.1 to Upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.

SECONDARY outcome

Timeframe: From randomization to second objective progression, or death from any cause, whichever occurs first (Up to 36 months)

Population: All randomized participants

Progression-free Survival (PFS)-2 based on investigator's assessment is defined as time from randomization to second objective progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) Number of patients who died	10 Participants	15 Participants
Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) Number of patients with first progression	40 Participants	60 Participants
Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) Number of patients with second progression	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Months 6, 12, 18, 24, 36

Population: All randomized participants

EFS rate is defined as the percentage of participants free of any EFS event at fixed timepoints. Complete response: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. Partial response: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Progression: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Metabolic progression: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Event-free Survival (EFS) Rate EFS Rate at 6 months	68.1 Percentage of participants Interval 58.6 to 77.7	36.2 Percentage of participants Interval 26.3 to 46.1
Event-free Survival (EFS) Rate EFS Rate at 12 months	57.0 Percentage of participants Interval 46.8 to 67.2	22.6 Percentage of participants Interval 13.9 to 31.3
Event-free Survival (EFS) Rate EFS Rate at 18 months	52.6 Percentage of participants Interval 42.3 to 62.8	22.6 Percentage of participants Interval 13.9 to 31.3
Event-free Survival (EFS) Rate EFS Rate at 24 months	51.4 Percentage of participants Interval 41.1 to 61.7	21.5 Percentage of participants Interval 13.0 to 30.0
Event-free Survival (EFS) Rate EFS Rate at 36 months	45.8 Percentage of participants Interval 35.2 to 56.5	19.1 Percentage of participants Interval 11.0 to 27.3

SECONDARY outcome

Timeframe: Months 6, 12, 18, 24, 36

Population: All randomized participants

Progression-free Survival (PFS) rate is defined as the percentage of participants free of any PFS event at fixed timepoints. Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Progression-free Survival (PFS) Rate PFS Rate at 6 months	73.7 Percentage of participants Interval 64.5 to 83.0	51.7 Percentage of participants Interval 40.2 to 63.1
Progression-free Survival (PFS) Rate PFS Rate at 12 months	63.0 Percentage of participants Interval 52.8 to 73.2	31.3 Percentage of participants Interval 20.3 to 42.4
Progression-free Survival (PFS) Rate PFS Rate at 18 months	58.2 Percentage of participants Interval 47.7 to 68.7	31.3 Percentage of participants Interval 20.3 to 42.4
Progression-free Survival (PFS) Rate PFS Rate at 24 months	57.0 Percentage of participants Interval 46.4 to 67.5	29.7 Percentage of participants Interval 18.8 to 40.7
Progression-free Survival (PFS) Rate PFS Rate at 36 months	50.9 Percentage of participants Interval 39.9 to 62.0	26.5 Percentage of participants Interval 15.9 to 37.1

SECONDARY outcome

Timeframe: Months 6, 12, 18, 24, 36

Population: All randomized participants

Overall Survival (OS) rate is defined as the percentage of participants alive at fixed timepoints. OS is defined as the time from randomization to death due to any cause. Participants alive or lost to follow up at the time of analysis will be censored at the last date the participants was known to be alive.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=92 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Overall Survival (OS) Rate OS Rate at 24 months	67.5 Percentage of participants Interval 57.8 to 77.2	58.2 Percentage of participants Interval 47.9 to 68.5
Overall Survival (OS) Rate OS Rate at 6 months	93.4 Percentage of participants Interval 88.4 to 98.5	88.9 Percentage of participants Interval 82.4 to 95.4
Overall Survival (OS) Rate OS Rate at 12 months	83.5 Percentage of participants Interval 75.8 to 91.1	72.0 Percentage of participants Interval 62.7 to 81.3
Overall Survival (OS) Rate OS Rate at 18 months	73.3 Percentage of participants Interval 64.2 to 82.5	61.7 Percentage of participants Interval 51.5 to 71.8
Overall Survival (OS) Rate OS Rate at 36 months	62.8 Percentage of participants Interval 52.7 to 72.9	51.8 Percentage of participants Interval 41.2 to 62.4
Overall Survival (OS) Rate Participants who died	37.0 Percentage of participants Only percentage of participants who died to be reported	45.7 Percentage of participants Only percentage of participants who died to be reported
Overall Survival (OS) Rate Participants who were censored	63.0 Percentage of participants Only percentage of participants who were censored to be reported	54.3 Percentage of participants Only percentage of participants who were censored to be reported

SECONDARY outcome

Timeframe: From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)

Population: All participants treated in any study medication per overall participants and in clinical, histological and molecular subgroups that are prespecified for this endpoint (subgroups are not mutually exclusive)

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. TEAEs are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=91 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Overall participants with TEAEs	92 Participants	90 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with TEAEs	60 Participants	57 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) NIH: Follicular Lymphoma Grade 3B with TEAEs	1 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) NIH: High-Grade B-cell Lymphoma with DLBCL Histology with TEAEs	22 Participants	20 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with TEAEs	8 Participants	9 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with TEAEs	1 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with TEAEs	53 Participants	49 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) DLBCL: DLBCL from Transformed Indolent NHL with TEAEs	7 Participants	8 Participants

SECONDARY outcome

Timeframe: From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)

A serious adverse event is defined as any adverse event occurring at any dose that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. Treatment emergent adverse events are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=91 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Overall Participants with serious TEAEs	43 Participants	45 Participants
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with serious TEAEs	23 Participants	29 Participants
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) NIH: Follicular Lymphoma Grade 3B with serious TEAEs	0 Participants	—
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) NIH: High-Grade B-cell Lymphoma with DLBCL Histology with serious TEAEs	17 Participants	9 Participants
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with serious TEAEs	2 Participants	4 Participants
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with serious TEAEs	1 Participants	3 Participants
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with serious TEAEs	20 Participants	25 Participants
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) DLBCL: DLBCL from Transformed Indolent NHL with serious TEAEs	3 Participants	4 Participants

SECONDARY outcome

Timeframe: baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36

Population: All treated participants with a baseline value and a post-baseline value at the time point

Change from baseline in hemoglobin. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=84 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=73 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 6	-3.16 g/L Standard Deviation 19.755	-6.80 g/L Standard Deviation 14.935
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 1	-14.94 g/L Standard Deviation 14.628	-16.98 g/L Standard Deviation 13.408
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 2	—	-25.00 g/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 3	-15.78 g/L Standard Deviation 19.410	-30.83 g/L Standard Deviation 19.013
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 4	—	-22.00 g/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 9	-0.52 g/L Standard Deviation 15.632	0.36 g/L Standard Deviation 19.242
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 12	3.32 g/L Standard Deviation 15.417	6.17 g/L Standard Deviation 14.598
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 18	7.38 g/L Standard Deviation 12.854	11.37 g/L Standard Deviation 14.592
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 24	7.38 g/L Standard Deviation 16.986	13.88 g/L Standard Deviation 18.996
Change From Baseline in Hematology Parameters 1: Hemoglobin Hemoglobin Month 36	13.63 g/L Standard Deviation 12.417	14.41 g/L Standard Deviation 16.978

SECONDARY outcome

Timeframe: baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36

Population: All treated participants with a baseline value and a post-baseline value at the time point

Change from baseline in selected hematology parameters such as leukocytes, lymphocytes, neutrophils, and platelets. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=84 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=73 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Change From Baseline in Selected Hematology Parameters 2 Month 1 leukocytes	-3.219 10^9 cells/L Standard Deviation 2.4688	0.815 10^9 cells/L Standard Deviation 6.9413
Change From Baseline in Selected Hematology Parameters 2 Month 2 leukocytes	—	-0.870 10^9 cells/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Hematology Parameters 2 Month 3 leukocytes	-2.234 10^9 cells/L Standard Deviation 2.3520	-3.445 10^9 cells/L Standard Deviation 5.8845
Change From Baseline in Selected Hematology Parameters 2 Month 4 leukocytes	—	-1.180 10^9 cells/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Hematology Parameters 2 Month 6 leukocytes	-1.853 10^9 cells/L Standard Deviation 2.5876	-1.699 10^9 cells/L Standard Deviation 1.9099
Change From Baseline in Selected Hematology Parameters 2 Month 9 leukocytes	-1.156 10^9 cells/L Standard Deviation 3.3604	-0.710 10^9 cells/L Standard Deviation 3.0670
Change From Baseline in Selected Hematology Parameters 2 Month 12 leukocytes	-1.138 10^9 cells/L Standard Deviation 2.3772	-0.427 10^9 cells/L Standard Deviation 1.4093
Change From Baseline in Selected Hematology Parameters 2 Month 18 leukocytes	-1.088 10^9 cells/L Standard Deviation 2.8028	-0.598 10^9 cells/L Standard Deviation 1.6136
Change From Baseline in Selected Hematology Parameters 2 Month 24 leukocytes	-0.806 10^9 cells/L Standard Deviation 2.5709	0.694 10^9 cells/L Standard Deviation 3.0465
Change From Baseline in Selected Hematology Parameters 2 Month 36 leukocytes	-0.970 10^9 cells/L Standard Deviation 3.0158	0.761 10^9 cells/L Standard Deviation 2.3637
Change From Baseline in Selected Hematology Parameters 2 Month 1 lymphocytes	-0.7380 10^9 cells/L Standard Deviation 0.43499	-0.2824 10^9 cells/L Standard Deviation 0.43519
Change From Baseline in Selected Hematology Parameters 2 Month 2 lymphocytes	—	-0.2100 10^9 cells/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Hematology Parameters 2 Month 3 lymphocytes	-0.1318 10^9 cells/L Standard Deviation 0.43385	-0.4216 10^9 cells/L Standard Deviation 0.55872
Change From Baseline in Selected Hematology Parameters 2 Month 4 lymphocytes	—	-0.1700 10^9 cells/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Hematology Parameters 2 Month 6 lymphocytes	-0.0845 10^9 cells/L Standard Deviation 0.48047	0.1343 10^9 cells/L Standard Deviation 0.38219
Change From Baseline in Selected Hematology Parameters 2 Month 9 lymphocytes	-0.0442 10^9 cells/L Standard Deviation 0.39684	0.3264 10^9 cells/L Standard Deviation 0.66121
Change From Baseline in Selected Hematology Parameters 2 Month 12 lymphocytes	0.0097 10^9 cells/L Standard Deviation 0.37252	0.5089 10^9 cells/L Standard Deviation 0.71831
Change From Baseline in Selected Hematology Parameters 2 Month 18 lymphocytes	0.2283 10^9 cells/L Standard Deviation 0.55421	0.6942 10^9 cells/L Standard Deviation 0.98993
Change From Baseline in Selected Hematology Parameters 2 Month 24 lymphocytes	0.3298 10^9 cells/L Standard Deviation 0.51386	0.8688 10^9 cells/L Standard Deviation 1.12695
Change From Baseline in Selected Hematology Parameters 2 Month 36 lymphocytes	0.3550 10^9 cells/L Standard Deviation 0.55387	1.2253 10^9 cells/L Standard Deviation 1.20268
Change From Baseline in Selected Hematology Parameters 2 Month 1 neutrophils	-2.065 10^9 cells/L Standard Deviation 2.3479	1.368 10^9 cells/L Standard Deviation 6.5393
Change From Baseline in Selected Hematology Parameters 2 Month 2 neutrophils	—	-0.590 10^9 cells/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Hematology Parameters 2 Month 3 neutrophils	-1.909 10^9 cells/L Standard Deviation 2.1727	-0.621 10^9 cells/L Standard Deviation 6.8377
Change From Baseline in Selected Hematology Parameters 2 Month 4 neutrophils	—	-1.160 10^9 cells/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Hematology Parameters 2 Month 6 neutrophils	-1.584 10^9 cells/L Standard Deviation 2.4539	-1.648 10^9 cells/L Standard Deviation 1.7635
Change From Baseline in Selected Hematology Parameters 2 Month 9 neutrophils	-1.001 10^9 cells/L Standard Deviation 3.1318	-0.879 10^9 cells/L Standard Deviation 2.9777
Change From Baseline in Selected Hematology Parameters 2 Month 12 neutrophils	-1.035 10^9 cells/L Standard Deviation 2.2898	-0.822 10^9 cells/L Standard Deviation 1.5780
Change From Baseline in Selected Hematology Parameters 2 Month 18 neutrophils	-1.189 10^9 cells/L Standard Deviation 2.6342	-1.167 10^9 cells/L Standard Deviation 1.3772
Change From Baseline in Selected Hematology Parameters 2 Month 24 neutrophils	-0.998 10^9 cells/L Standard Deviation 2.5506	-0.124 10^9 cells/L Standard Deviation 2.5434
Change From Baseline in Selected Hematology Parameters 2 Month 36 neutrophils	-0.998 10^9 cells/L Standard Deviation 2.5222	-0.404 10^9 cells/L Standard Deviation 1.8392
Change From Baseline in Selected Hematology Parameters 2 Month 1 platelets	29.4 10^9 cells/L Standard Deviation 115.53	13.9 10^9 cells/L Standard Deviation 140.94
Change From Baseline in Selected Hematology Parameters 2 Month 2 platelets	—	13.0 10^9 cells/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Hematology Parameters 2 Month 3 platelets	-65.7 10^9 cells/L Standard Deviation 100.52	-189.5 10^9 cells/L Standard Deviation 132.93
Change From Baseline in Selected Hematology Parameters 2 Month 4 platelets	—	-74.0 10^9 cells/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Hematology Parameters 2 Month 6 platelets	-48.2 10^9 cells/L Standard Deviation 89.04	-45.5 10^9 cells/L Standard Deviation 94.13
Change From Baseline in Selected Hematology Parameters 2 Month 9 platelets	-48.9 10^9 cells/L Standard Deviation 89.29	-57.0 10^9 cells/L Standard Deviation 110.48
Change From Baseline in Selected Hematology Parameters 2 Month 12 platelets	-42.4 10^9 cells/L Standard Deviation 92.65	-66.5 10^9 cells/L Standard Deviation 85.82
Change From Baseline in Selected Hematology Parameters 2 Month 18 platelets	-32.6 10^9 cells/L Standard Deviation 81.68	-68.0 10^9 cells/L Standard Deviation 84.69
Change From Baseline in Selected Hematology Parameters 2 Month 24 platelets	-28.7 10^9 cells/L Standard Deviation 79.70	-29.4 10^9 cells/L Standard Deviation 103.87
Change From Baseline in Selected Hematology Parameters 2 Month 36 platelets	-10.5 10^9 cells/L Standard Deviation 72.79	-45.2 10^9 cells/L Standard Deviation 123.28

SECONDARY outcome

Timeframe: baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36

Population: All treated participants with a baseline value and a post-baseline value at the time point

Change from baseline in selected chemistry parameters such as alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=88 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=76 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Change From Baseline in Selected Chemistry Parameters 1 Month 6 Lactate Dehydrogenase	-53.7 U/L Standard Deviation 183.53	-85.5 U/L Standard Deviation 310.71
Change From Baseline in Selected Chemistry Parameters 1 Month 1 Alanine Aminotransferase	-0.52 U/L Standard Deviation 18.337	17.22 U/L Standard Deviation 25.997
Change From Baseline in Selected Chemistry Parameters 1 Month 2 Alanine Aminotransferase	—	4.00 U/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 1 Month 3 Alanine Aminotransferase	2.53 U/L Standard Deviation 13.246	-3.40 U/L Standard Deviation 22.295
Change From Baseline in Selected Chemistry Parameters 1 Month 4 Alanine Aminotransferase	—	-3.00 U/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 1 Month 6 Alanine Aminotransferase	3.08 U/L Standard Deviation 14.813	2.81 U/L Standard Deviation 21.067
Change From Baseline in Selected Chemistry Parameters 1 Month 9 Alanine Aminotransferase	5.23 U/L Standard Deviation 16.660	2.43 U/L Standard Deviation 20.165
Change From Baseline in Selected Chemistry Parameters 1 Month 12 Alanine Aminotransferase	4.19 U/L Standard Deviation 19.653	0.72 U/L Standard Deviation 23.542
Change From Baseline in Selected Chemistry Parameters 1 Month 18 Alanine Aminotransferase	-0.45 U/L Standard Deviation 10.943	10.40 U/L Standard Deviation 15.892
Change From Baseline in Selected Chemistry Parameters 1 Month 24 Alanine Aminotransferase	1.88 U/L Standard Deviation 13.211	7.69 U/L Standard Deviation 15.134
Change From Baseline in Selected Chemistry Parameters 1 Month 36 Alanine Aminotransferase	13.98 U/L Standard Deviation 104.054	12.41 U/L Standard Deviation 17.429
Change From Baseline in Selected Chemistry Parameters 1 Month 1 Aspartate Aminotransferase	2.03 U/L Standard Deviation 17.526	3.38 U/L Standard Deviation 16.624
Change From Baseline in Selected Chemistry Parameters 1 Month 2 Aspartate Aminotransferase	—	5.00 U/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 1 Month 3 Aspartate Aminotransferase	-1.24 U/L Standard Deviation 8.800	-6.47 U/L Standard Deviation 17.248
Change From Baseline in Selected Chemistry Parameters 1 Month 4 Aspartate Aminotransferase	—	3.00 U/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 1 Month 6 Aspartate Aminotransferase	1.78 U/L Standard Deviation 8.550	1.23 U/L Standard Deviation 15.911
Change From Baseline in Selected Chemistry Parameters 1 Month 9 Aspartate Aminotransferase	2.12 U/L Standard Deviation 10.355	3.68 U/L Standard Deviation 12.549
Change From Baseline in Selected Chemistry Parameters 1 Month 12 Aspartate Aminotransferase	1.88 U/L Standard Deviation 13.200	-1.44 U/L Standard Deviation 16.180
Change From Baseline in Selected Chemistry Parameters 1 Month 18 Aspartate Aminotransferase	-1.22 U/L Standard Deviation 7.452	4.90 U/L Standard Deviation 7.663
Change From Baseline in Selected Chemistry Parameters 1 Month 24 Aspartate Aminotransferase	0.90 U/L Standard Deviation 10.757	4.63 U/L Standard Deviation 9.172
Change From Baseline in Selected Chemistry Parameters 1 Month 36 Aspartate Aminotransferase	14.95 U/L Standard Deviation 94.651	9.06 U/L Standard Deviation 15.117
Change From Baseline in Selected Chemistry Parameters 1 Month 1 Lactate Dehydrogenase	-14.0 U/L Standard Deviation 203.18	-66.7 U/L Standard Deviation 222.79
Change From Baseline in Selected Chemistry Parameters 1 Month 2 Lactate Dehydrogenase	—	27.0 U/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 1 Month 3 Lactate Dehydrogenase	-84.1 U/L Standard Deviation 183.29	-57.2 U/L Standard Deviation 377.22
Change From Baseline in Selected Chemistry Parameters 1 Month 4 Lactate Dehydrogenase	—	117.0 U/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 1 Month 9 Lactate Dehydrogenase	-62.0 U/L Standard Deviation 186.25	-85.0 U/L Standard Deviation 362.52
Change From Baseline in Selected Chemistry Parameters 1 Month 12 Lactate Dehydrogenase	-41.9 U/L Standard Deviation 207.30	-52.9 U/L Standard Deviation 74.56
Change From Baseline in Selected Chemistry Parameters 1 Month 18 Lactate Dehydrogenase	-50.8 U/L Standard Deviation 133.31	-44.1 U/L Standard Deviation 71.19
Change From Baseline in Selected Chemistry Parameters 1 Month 24 Lactate Dehydrogenase	-63.3 U/L Standard Deviation 148.25	-45.6 U/L Standard Deviation 75.04
Change From Baseline in Selected Chemistry Parameters 1 Month 36 Lactate Dehydrogenase	-59.9 U/L Standard Deviation 124.62	-46.0 U/L Standard Deviation 85.14

SECONDARY outcome

Timeframe: baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36

Population: All treated participants with a baseline value and a post-baseline value at the time point

Change from baseline in selected chemistry parameters such as magnesium, phosphate, potassium, and sodium. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=88 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=76 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Change From Baseline in Selected Chemistry Parameters 2 Month 1 magnesium	0.009 mmol/L Standard Deviation 0.0933	-0.023 mmol/L Standard Deviation 0.1145
Change From Baseline in Selected Chemistry Parameters 2 Month 2 magnesium	—	-0.080 mmol/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 2 Month 3 magnesium	0.007 mmol/L Standard Deviation 0.1010	-0.063 mmol/L Standard Deviation 0.1210
Change From Baseline in Selected Chemistry Parameters 2 Month 4 magnesium	—	-0.200 mmol/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 2 Month 6 magnesium	0.015 mmol/L Standard Deviation 0.1090	-0.041 mmol/L Standard Deviation 0.1452
Change From Baseline in Selected Chemistry Parameters 2 Month 9 magnesium	0.025 mmol/L Standard Deviation 0.1079	-0.027 mmol/L Standard Deviation 0.1459
Change From Baseline in Selected Chemistry Parameters 2 Month 12 magnesium	0.031 mmol/L Standard Deviation 0.1054	0.012 mmol/L Standard Deviation 0.1047
Change From Baseline in Selected Chemistry Parameters 2 Month 18 magnesium	0.032 mmol/L Standard Deviation 0.1065	0.033 mmol/L Standard Deviation 0.0639
Change From Baseline in Selected Chemistry Parameters 2 Month 24 magnesium	0.015 mmol/L Standard Deviation 0.1027	0.040 mmol/L Standard Deviation 0.1145
Change From Baseline in Selected Chemistry Parameters 2 Month 36 magnesium	0.011 mmol/L Standard Deviation 0.0751	0.039 mmol/L Standard Deviation 0.0920
Change From Baseline in Selected Chemistry Parameters 2 Month 1 phosphate	-0.038 mmol/L Standard Deviation 0.2498	-0.061 mmol/L Standard Deviation 0.2643
Change From Baseline in Selected Chemistry Parameters 2 Month 2 phosphate	—	0.030 mmol/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 2 Month 3 phosphate	0.039 mmol/L Standard Deviation 0.2316	-0.128 mmol/L Standard Deviation 0.3299
Change From Baseline in Selected Chemistry Parameters 2 Month 4 phosphate	—	0.130 mmol/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 2 Month 6 phosphate	-0.020 mmol/L Standard Deviation 0.2276	0.140 mmol/L Standard Deviation 0.2166
Change From Baseline in Selected Chemistry Parameters 2 Month 9 phosphate	-0.028 mmol/L Standard Deviation 0.2098	0.025 mmol/L Standard Deviation 0.2020
Change From Baseline in Selected Chemistry Parameters 2 Month 12 phosphate	-0.090 mmol/L Standard Deviation 0.2051	-0.021 mmol/L Standard Deviation 0.1578
Change From Baseline in Selected Chemistry Parameters 2 Month 18 phosphate	-0.059 mmol/L Standard Deviation 0.2224	-0.025 mmol/L Standard Deviation 0.2666
Change From Baseline in Selected Chemistry Parameters 2 Month 24 phosphate	-0.061 mmol/L Standard Deviation 0.2549	-0.064 mmol/L Standard Deviation 0.2469
Change From Baseline in Selected Chemistry Parameters 2 Month 36 phosphate	-0.061 mmol/L Standard Deviation 0.2053	-0.044 mmol/L Standard Deviation 0.2464
Change From Baseline in Selected Chemistry Parameters 2 Month 1 potassium	-0.05 mmol/L Standard Deviation 0.460	-0.08 mmol/L Standard Deviation 0.400
Change From Baseline in Selected Chemistry Parameters 2 Month 2 potassium	—	0.30 mmol/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 2 Month 3 potassium	0.00 mmol/L Standard Deviation 0.428	-0.33 mmol/L Standard Deviation 0.604
Change From Baseline in Selected Chemistry Parameters 2 Month 4 potassium	—	0.80 mmol/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 2 Month 6 potassium	0.08 mmol/L Standard Deviation 0.359	0.11 mmol/L Standard Deviation 0.337
Change From Baseline in Selected Chemistry Parameters 2 Month 9 potassium	0.12 mmol/L Standard Deviation 0.391	-0.06 mmol/L Standard Deviation 0.447
Change From Baseline in Selected Chemistry Parameters 2 Month 12 potassium	0.06 mmol/L Standard Deviation 0.491	0.01 mmol/L Standard Deviation 0.445
Change From Baseline in Selected Chemistry Parameters 2 Month 18 potassium	0.15 mmol/L Standard Deviation 0.411	0.06 mmol/L Standard Deviation 0.380
Change From Baseline in Selected Chemistry Parameters 2 Month 24 potassium	0.09 mmol/L Standard Deviation 0.435	0.09 mmol/L Standard Deviation 0.516
Change From Baseline in Selected Chemistry Parameters 2 Month 36 potassium	0.11 mmol/L Standard Deviation 0.430	0.07 mmol/L Standard Deviation 0.549
Change From Baseline in Selected Chemistry Parameters 2 month 1 sodium	-1.09 mmol/L Standard Deviation 2.875	-2.75 mmol/L Standard Deviation 3.493
Change From Baseline in Selected Chemistry Parameters 2 month 2 sodium	—	-1.00 mmol/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 2 month 3 sodium	0.59 mmol/L Standard Deviation 3.054	-1.86 mmol/L Standard Deviation 4.496
Change From Baseline in Selected Chemistry Parameters 2 month 4 sodium	—	-2.00 mmol/L Standard Deviation NA insufficient number of participants to calculate standard deviation
Change From Baseline in Selected Chemistry Parameters 2 month 6 sodium	0.33 mmol/L Standard Deviation 3.222	-0.42 mmol/L Standard Deviation 2.514
Change From Baseline in Selected Chemistry Parameters 2 month 9 sodium	-0.08 mmol/L Standard Deviation 3.111	0.52 mmol/L Standard Deviation 2.108
Change From Baseline in Selected Chemistry Parameters 2 month 12 sodium	-0.34 mmol/L Standard Deviation 4.046	0.33 mmol/L Standard Deviation 2.114
Change From Baseline in Selected Chemistry Parameters 2 month 18 sodium	0.74 mmol/L Standard Deviation 3.572	0.45 mmol/L Standard Deviation 2.964
Change From Baseline in Selected Chemistry Parameters 2 month 24 sodium	1.02 mmol/L Standard Deviation 3.795	-1.00 mmol/L Standard Deviation 3.246
Change From Baseline in Selected Chemistry Parameters 2 month 36 sodium	0.25 mmol/L Standard Deviation 3.432	-0.44 mmol/L Standard Deviation 2.229

SECONDARY outcome

Timeframe: From randomization to PR or CR (Up to 36 months)

Population: All randomized participants per clinical, histological and molecular subgroups that are pre-specified for ORR (subgroups are not mutually exclusive and participants are not exclusive to one subgroup)

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=70 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=72 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Overall Response Rate (ORR) by Subgroups Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)	86.7 Percentage of participants Interval 75.4 to 94.1	51.7 Percentage of participants Interval 38.2 to 65.0
Overall Response Rate (ORR) by Subgroups NIH: Follicular Lymphoma Grade 3B	100 Percentage of participants Interval 2.5 to 100.0	—
Overall Response Rate (ORR) by Subgroups NIH: High-Grade B-cell Lymphoma with DLBCL Histology	81.8 Percentage of participants Interval 59.7 to 94.8	42.9 Percentage of participants Interval 21.8 to 66.0
Overall Response Rate (ORR) by Subgroups NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma	100 Percentage of participants Interval 63.1 to 100.0	33.3 Percentage of participants Interval 7.5 to 70.1
Overall Response Rate (ORR) by Subgroups NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma	100 Percentage of participants Interval 2.5 to 100.0	75.0 Percentage of participants Interval 19.4 to 99.4
Overall Response Rate (ORR) by Subgroups Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo	86.8 Percentage of participants Interval 74.7 to 94.5	54.0 Percentage of participants Interval 39.3 to 68.2
Overall Response Rate (ORR) by Subgroups DLBCL: DLBCL from Transformed Indolent NHL	85.7 Percentage of participants Interval 42.1 to 99.6	37.5 Percentage of participants Interval 8.5 to 75.5
Overall Response Rate (ORR) by Subgroups DLBCL: Germinal Center B-cell like (GCB)	91.1 Percentage of participants Interval 78.8 to 97.5	50.0 Percentage of participants Interval 33.8 to 66.2
Overall Response Rate (ORR) by Subgroups DLBCL: Activated B-cell-like, non-GCB	85.7 Percentage of participants Interval 63.7 to 97.0	44.8 Percentage of participants Interval 26.4 to 64.3
Overall Response Rate (ORR) by Subgroups NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)	81.8 Percentage of participants Interval 59.7 to 94.8	40.0 Percentage of participants Interval 19.1 to 63.9
Overall Response Rate (ORR) by Subgroups NHL: Non-DHL/THL	88.6 Percentage of participants Interval 78.7 to 94.9	51.4 Percentage of participants Interval 39.3 to 63.3

SECONDARY outcome

Population: All randomized participants per clinical, histological and molecular subgroups that are pre-specified for EFS (subgroups are not mutually exclusive)

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=70 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=72 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Event-free Survival (EFS) by Subgroups DLBCL: DLBCL from Transformed Indolent NHL	NA Months Interval 1.9 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	2.1 Months Interval 1.2 to 11.2
Event-free Survival (EFS) by Subgroups DLBCL: Germinal Center B-cell like (GCB)	11.7 Months Interval 6.0 to The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	2.1 Months Interval 1.6 to 4.9
Event-free Survival (EFS) by Subgroups DLBCL: Activated B-cell-like, non-GCB	33.2 Months Interval 4.9 to The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	2.3 Months Interval 2.1 to 7.5
Event-free Survival (EFS) by Subgroups NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)	4.6 Months Interval 4.1 to 12.6	2.1 Months Interval 0.9 to 3.9
Event-free Survival (EFS) by Subgroups NHL: Non-DHL/THL	NA Months Interval 15.6 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	2.8 Months Interval 2.2 to 6.4
Event-free Survival (EFS) by Subgroups Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)	NA Months Interval 9.5 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	3.0 Months Interval 2.2 to 6.4
Event-free Survival (EFS) by Subgroups NIH: Follicular Lymphoma Grade 3B	NA Months Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	—
Event-free Survival (EFS) by Subgroups NIH: High-Grade B-cell Lymphoma with DLBCL Histology	4.6 Months Interval 4.1 to 12.6	2.2 Months Interval 0.9 to 3.9
Event-free Survival (EFS) by Subgroups NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma	NA Months Interval 11.0 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	2.2 Months Interval 1.0 to The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Event-free Survival (EFS) by Subgroups NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma	NA Months Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	NA Months Interval 2.3 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Event-free Survival (EFS) by Subgroups Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo	33.2 Months Interval 9.4 to The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	4.4 Months Interval 2.2 to 7.5

SECONDARY outcome

Timeframe: From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)

Population: All randomized participants per clinical, histological and molecular subgroups that are pre-specified for PFS (subgroups are not mutually exclusive)

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=70 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=72 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Progression-free Survival (PFS) by Subgroups Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)	NA Months Interval 30.9 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	6.0 Months Interval 2.9 to 8.6
Progression-free Survival (PFS) by Subgroups NIH: Follicular Lymphoma Grade 3B	NA Months Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	—
Progression-free Survival (PFS) by Subgroups NIH: High-Grade B-cell Lymphoma with DLBCL Histology	5.8 Months Interval 4.3 to 14.8	4.3 Months Interval 1.4 to 6.5
Progression-free Survival (PFS) by Subgroups NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma	NA Months Interval 11.0 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	NA Months Interval 1.0 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Progression-free Survival (PFS) by Subgroups NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma	NA Months Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	NA Months Interval 28.2 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Progression-free Survival (PFS) by Subgroups Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo	NA Months Interval 12.2 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	6.4 Months Interval 3.1 to 8.6
Progression-free Survival (PFS) by Subgroups DLBCL: DLBCL from Transformed Indolent NHL	NA Months Interval 2.3 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	3.4 Months Interval 1.2 to the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Progression-free Survival (PFS) by Subgroups DLBCL: Germinal Center B-cell like (GCB)	14.8 Months Interval 6.2 to the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	4.6 Months Interval 2.0 to 6.4
Progression-free Survival (PFS) by Subgroups DLBCL: Activated B-cell-like, non-GCB	33.2 Months Interval 6.6 to the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	7.5 Months Interval 2.3 to 9.4
Progression-free Survival (PFS) by Subgroups NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)	5.8 Months Interval 4.3 to 14.8	4.3 Months Interval 1.4 to 6.5
Progression-free Survival (PFS) by Subgroups NHL: Non-DHL/THL	NA Months Interval 33.2 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	6.4 Months Interval 4.6 to 9.4

SECONDARY outcome

Timeframe: From randomization to time of death due to any cause (Up to 36 months)

Population: All randomized participants per clinical, histological and molecular subgroups that are pre-specified for OS (subgroups are not mutually exclusive)

Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=70 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=72 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Overall Survival (OS) by Subgroups NHL: Non-DHL/THL	NA Months Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	NA Months Interval 27.5 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Overall Survival (OS) by Subgroups Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)	NA Months Interval 42.8 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	NA Months Interval 17.0 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Overall Survival (OS) by Subgroups NIH: Follicular Lymphoma Grade 3B	NA Months Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	—
Overall Survival (OS) by Subgroups NIH: High-Grade B-cell Lymphoma with DLBCL Histology	13.3 Months Interval 7.9 to The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	16.3 Months Interval 5.3 to The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Overall Survival (OS) by Subgroups NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma	NA Months Interval 11.0 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	NA Months Interval 17.9 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Overall Survival (OS) by Subgroups NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma	NA Months Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	NA Months Interval 8.9 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Overall Survival (OS) by Subgroups Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo	NA Months Interval 42.8 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	NA Months Interval 16.7 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Overall Survival (OS) by Subgroups DLBCL: DLBCL from Transformed Indolent NHL	NA Months Interval 14.2 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	28.2 Months Interval 2.0 to The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Overall Survival (OS) by Subgroups DLBCL: Germinal Center B-cell like (GCB)	NA Months Interval 15.8 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	NA Months Interval 18.2 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Overall Survival (OS) by Subgroups DLBCL: Activated B-cell-like, non-GCB	NA Months Interval 32.4 to Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	16.3 Months Interval 9.7 to The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Overall Survival (OS) by Subgroups NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)	13.3 Months Interval 7.9 to The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events	16.3 Months Interval 5.3 to 30.7

SECONDARY outcome

Timeframe: baseline, months 1, 6, 9, 12, 18, 24, 36

Population: All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point

Change from baseline in EORTC QLQ-C30 specified parameters including global health/quality of life, cognitive functioning, physical functioning, and fatigue. It is 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. Symptom scale/item higher score represents a high level of symptomatic problem. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=43 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=41 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Global Health/Quality of Life Month 1	-5.23 score on a scale Standard Deviation 18.004	-9.55 score on a scale Standard Deviation 25.655
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Global Health/Quality of Life Month 6	12.36 score on a scale Standard Deviation 23.635	-2.78 score on a scale Standard Deviation 24.734
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Global Health/Quality of Life Month 9	12.50 score on a scale Standard Deviation 22.252	5.30 score on a scale Standard Deviation 24.516
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Global Health/Quality of Life Month 12	8.93 score on a scale Standard Deviation 24.525	15.63 score on a scale Standard Deviation 32.865
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Global Health/Quality of Life Month 18	8.33 score on a scale Standard Deviation 23.442	14.81 score on a scale Standard Deviation 29.397
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Global Health/Quality of Life Month 24	7.29 score on a scale Standard Deviation 23.093	12.50 score on a scale Standard Deviation 28.934
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Global Health/Quality of Life Month 36	2.67 score on a scale Standard Deviation 21.071	15.00 score on a scale Standard Deviation 21.802
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Month 1	-4.03 score on a scale Standard Deviation 16.339	-8.94 score on a scale Standard Deviation 19.867
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Month 6	2.24 score on a scale Standard Deviation 17.470	-2.08 score on a scale Standard Deviation 11.081
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Month 9	5.00 score on a scale Standard Deviation 21.825	0.61 score on a scale Standard Deviation 9.167
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Month 12	4.52 score on a scale Standard Deviation 17.875	10.00 score on a scale Standard Deviation 17.817
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Month 18	1.73 score on a scale Standard Deviation 17.027	13.33 score on a scale Standard Deviation 22.608
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Month 24	2.78 score on a scale Standard Deviation 22.147	10.67 score on a scale Standard Deviation 18.645
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Month 36	-1.87 score on a scale Standard Deviation 16.613	7.33 score on a scale Standard Deviation 15.540
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Cognitive Functioning Month 1	-0.39 score on a scale Standard Deviation 16.462	-8.54 score on a scale Standard Deviation 19.047
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Cognitive Functioning Month 36	2.67 score on a scale Standard Deviation 17.795	-1.67 score on a scale Standard Deviation 9.461
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Fatigue Month 1	0.26 score on a scale Standard Deviation 20.501	19.24 score on a scale Standard Deviation 24.848
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Fatigue Month 6	-12.84 score on a scale Standard Deviation 29.811	0.69 score on a scale Standard Deviation 27.657
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Cognitive Functioning Month 6	3.45 score on a scale Standard Deviation 20.596	-3.33 score on a scale Standard Deviation 14.365
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Cognitive Functioning Month 9	9.72 score on a scale Standard Deviation 23.008	-3.03 score on a scale Standard Deviation 16.361
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Cognitive Functioning Month 12	4.17 score on a scale Standard Deviation 27.074	-4.17 score on a scale Standard Deviation 7.715
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Cognitive Functioning Month 18	4.17 score on a scale Standard Deviation 26.580	0.00 score on a scale Standard Deviation 18.634
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Cognitive Functioning Month 24	0.00 score on a scale Standard Deviation 26.919	0.00 score on a scale Standard Deviation 13.608
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Fatigue Month 9	-10.65 score on a scale Standard Deviation 36.702	-4.04 score on a scale Standard Deviation 29.090
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Fatigue Month 12	-9.52 score on a scale Standard Deviation 33.363	-6.94 score on a scale Standard Deviation 8.267
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Fatigue Month 18	-10.22 score on a scale Standard Deviation 30.919	-6.17 score on a scale Standard Deviation 22.299
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Fatigue Month 24	-8.80 score on a scale Standard Deviation 30.557	-6.67 score on a scale Standard Deviation 19.030
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Fatigue Month 36	-5.33 score on a scale Standard Deviation 25.884	-3.33 score on a scale Standard Deviation 16.605

SECONDARY outcome

Timeframe: baseline, months 1, 6, 9, 12, 18, 24, 36

Population: All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point

Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma 15-item lymphoma-specific "Additional concerns" subscale (FACT-Lym). 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. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). A meaningful change from baseline in the FACT-Lym score, often referred to as the minimally important difference (MID), typically ranges between 6.5 and 11.2 points for the total score. This range indicates a clinically significant improvement or deterioration in a patient's health-related quality of life.

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=40 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=38 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) Month 1	0.35 score on a scale Standard Deviation 7.329	-0.76 score on a scale Standard Deviation 5.558
Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) Month 6	3.52 score on a scale Standard Deviation 10.805	2.19 score on a scale Standard Deviation 9.474
Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) Month 9	5.48 score on a scale Standard Deviation 14.330	0.11 score on a scale Standard Deviation 9.597
Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) Month 12	3.93 score on a scale Standard Deviation 13.485	5.43 score on a scale Standard Deviation 3.645
Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) Month 18	2.56 score on a scale Standard Deviation 12.149	3.50 score on a scale Standard Deviation 5.632
Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) Month 24	2.18 score on a scale Standard Deviation 12.374	5.20 score on a scale Standard Deviation 5.789
Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) Month 36	0.50 score on a scale Standard Deviation 9.478	4.90 score on a scale Standard Deviation 5.152

SECONDARY outcome

Timeframe: Up to 36 months

Population: All participants treated in any study medication

Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU)

Outcome measures

Outcome measures
Measure	Liso-cel Arm n=92 Participants \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=91 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Hospital Resource Utilization (HRU) Results Admitted to Intensive Care Unit (ICU)	5 Participants	4 Participants
Hospital Resource Utilization (HRU) Results Hospitalized	87 Participants	74 Participants
Hospital Resource Utilization (HRU) Results Hospitalized due to Adverse Event (AE)	44 Participants	42 Participants
Hospital Resource Utilization (HRU) Results Hospitalized due to Progression of Disease	6 Participants	2 Participants
Hospital Resource Utilization (HRU) Results Hospitalized per protocol	22 Participants	11 Participants
Hospital Resource Utilization (HRU) Results Hospitalized due to other reasons	71 Participants	56 Participants

SECONDARY outcome

Timeframe: Up to 5 months after first dose

Population: All treated participants in SOC arm

Percentage of Participants Completing High Dose Chemotherapy (HDCT).

Outcome measures

Outcome measures
Measure	Liso-cel Arm \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=91 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Percentage of Participants Completing High Dose Chemotherapy (HDCT)	—	47.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to 5 months after first dose

Population: All treated participants in SOC arm

Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT).

Outcome measures

Outcome measures
Measure	Liso-cel Arm \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)	Standard of Care Arm n=91 Participants 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT)	—	47.3 Percentage of participants

Adverse Events

SOC Arm (Pre-crossover Only)

Serious events: 21 serious events

Other events: 30 other events

Deaths: 9 deaths

Liso-cel Arm Only

Serious events: 43 serious events

Other events: 92 other events

Deaths: 34 deaths

SOC-JCAR017 Arm Pre- and Post-Crossover (All Crossed)

Serious events: 19 serious events

Other events: 57 other events

Deaths: 33 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email:

Email: [email protected]

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