A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for... | NCT03744676

NCT03744676

Status Module

Sponsor/Collaborators Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lisocabtagene maraleucel	Experimental	Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of lisocabtagene maraleucel. During lisocabtagene maraleucel production, subjects may receive low-dose chemotherapy for disease control. Upon successful generation of lisocabtagene maraleucel product, subjects will receive treatment which will include lymphodepleting chemotherapy followed by one dose of lisocabtagene maraleucel administered by intravenous (IV) injection.	Biological: lisocabtagene maraleucel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lisocabtagene maraleucel	Biological	lisocabtagene maraleucel will be administered as single dose intravenous (IV) injection	Lisocabtagene maraleucel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Cytokine Release Syndrome (CRS) Adverse Events Grade ≥ 3	Cytokine release syndrome is characterized by high fever, fatigue, nausea, headache, dyspnea, tachycardia, rigors, hypotension, hypoxia, myalgia/arthralgia, and anorexia. Incidence of Grade ≥ 3 CRS, based on the TEAE with MedDRA PT "Cytokine release syndrome," graded according to the grading scale adapted from Lee (Lee 2014).	From first dose to 90 days following first dose (up to approximately 90 days)
Percentage of Participants With Neurotoxicity (NT) Adverse Events Grade ≥ 3	NT events have also been reported and may include neurologic symptoms such as altered mental status, aphasia, altered level of consciousness, and seizures or seizure-like activity. Incidence of Grade ≥ 3 NT, defined as an Investigator-identified TEAE considered neurotoxicity related to JCAR017.	From first dose to 90 days following first dose (up to approximately 90 days)
Percentage of Participants With Infection Adverse Events Grade ≥ 3	Incidence of treatment-emergent Grade ≥ 3 infections, defined using MedDRA SOC.	From first dose to 90 days following first dose (up to approximately 90 days)
Percentage of Participants With Grade ≥ 3 Prolonged Cytopenia at Day 29.	Prolonged cytopenia is defined as the occurrence of Grade ≥ 3 cytopenia not resolved by the Day 29 visit, based on laboratory results of low hemoglobin, absolute neutrophil count decreased, and platelet count decreased. The frequency of subjects experiencing each individual laboratory abnormality and the total number with at least 1 abnormality will be summarized, as will recovery from prolonged cytopenia after Day 29.	At Day 29 after first treatment

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events		From first dose to 90 days following first dose (up to approximately 90 days)
Number of Participants With Clinically Significant Laboratory Abnormalities- Hematology		From first dose to up to 41 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years at the time of consent
Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL from indolent histologies, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology, primary mediastinal B-cell lymphoma(PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 systemic lines of therapy for DLBCL or after auto-HSCT.
Positron-emission tomography-positive disease by Lugano Classification
Eastern Cooperative Oncology Group performance status of 0 to 1
Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function
Adequate vascular access for leukapheresis procedure
Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
Subjects must agree to use appropriate contraception.

Exclusion Criteria:

Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
History of prior allogeneic hematopoietic stem cell transplant
Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
History of another primary malignancy that has not been in remission for at least 2 years.The following are examples of exceptions from the 2-year limit: nonmelanoma skin cancer, definitively-treated stage 1 solid tumor with a low risk of recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on a Papanicolau smear.
Active hepatitis B or hepatitis C infection at the time of screening
History of or active human immunodeficiency virus infection at the time of screening
Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate anti-infection treatment at the time of leukapheresis or lisocabtagene maraleucel administration
Presence of acute or chronic graft-versus-host disease
History of clinically significant cardiac conditions within the past 6 months
History or presence of clinically relevant CNS pathology such as epilepsy/seizure, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Pregnant or nursing women
Subject does not meet protocol-specified washout periods for certain prior treatments
Prior CAR T-cell or other genetically modified T-cell therapy
Progressive vascular tumor invasion, thrombosis, or embolism
Venous thrombosis or embolism not managed on stable regimen of anticoagulation
Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0057		Los Angeles	California	90048	United States
Local Institution - 0060

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39347584	Derived	Linhares Y, Freytes CO, Cherry M, Bachier C, Maris M, Hoda D, Varela JC, Bellomo C, Cross S, Essell J, Fanning S, Terebelo H, Yimer H, Courtright J, Sharman JP, Kostic A, Vedal M, Ogasawara K, Avilion A, Espinola R, Yuan B, Mattar B. OUTREACH: phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL. Blood Adv. 2024 Dec 10;8(23):6114-6126. doi: 10.1182/bloodadvances.2024013254.
34515338

Label	URL
BMS Clinical Trial Information	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 17, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00064.9± 11.61

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00038
Male	BG00066

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00019
Not Hispanic or Latino	BG00077

Race/Ethnicity, Customized

Race

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00088

Other

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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

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

All participants who received at least one JCAR017 infusion

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG00082

Title

Denominators

Categories

Title	Measurements
	OG0000.0(0.0 to 4.4)

Primary

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

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

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

All participants who received at least one JCAR017 infusion

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Primary

Percentage of Participants With Infection Adverse Events Grade ≥ 3

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

All participants who received at least one JCAR017 infusion

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Primary

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

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

All participants who received at least one JCAR017 infusion

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 29 after first treatment

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants

Secondary

Number of Participants With Adverse Events

All participants who received at least one JCAR017 infusion

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically Significant Laboratory Abnormalities- Hematology

All participants who received at least one JCAR017 infusion

Posted

Count of Participants

Participants

From first dose to up to 41 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically Significant Laboratory Abnormalities- Chemistry

All participants who received at least one JCAR017 infusion

Posted

Count of Participants

Participants

From first dose to up to 41 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Adverse Events Grade ≥ 3

All participants who received at least one JCAR017 infusion

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Time to Onset and Time to Resolution of Grade ≥ 3 Cytokine Release Syndrome (CRS)

All participants who received at least one JCAR017 infusion

Posted

Median

Full Range

Days

From first dose to up to approximately 41 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Time to Onset and Time to Resolution of Grade ≥ 3 Neurotoxicity (NT)

All participants who received at least one JCAR017 infusion

Posted

Median

Full Range

Days

From first dose to up to approximately 41 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Number of Participants Administered Tocilizumab and Corticosteroid for Management of Cytokine Release Syndrome (CRS)

All participants who received at least one JCAR017 infusion

Posted

Count of Participants

Participants

From first dose to up to approximately 41 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Number of Participants Administered Tocilizumab and Corticosteroid for Management of Neurotoxicity (NT)

All participants who received at least one JCAR017 infusion

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Objective Response Rate (ORR)

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

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

Complete response is defined as:

Score 1, 2, or 3a with or without residual mass
No evidence of FDG-avid disease in marrow

Partial Response is defined as:

Score 4 or 5a with reduced uptake compared with baseline and residual masses of any size
Bone marrow with residual uptake higher than in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in marrow in the context of a nodal response, should consider further evaluation with MRI, biopsy, or interval scan.

All participants who received at least one JCAR017 infusion

Posted

Number

95% Confidence Interval

Percentage of Participants

From first dose to up to approximately 41 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Secondary

Complete Response Rate (CRR)

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

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

Complete response is defined as:

Score 1, 2, or 3a with or without residual mass
No evidence of FDG-avid disease in marrow

All participants who received at least one JCAR017 infusion

Posted

Number

95% Confidence Interval

Percentage of Participants

From first dose to up to approximately 41 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Duration of Response (DoR) and Duration of Complete Response (DoCR)

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

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

All participants who received at least one JCAR017 infusion

Posted

Median

Full Range

Months

From first dose to up to approximately 41 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Progression Free Survival (PFS)

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

Progressive Disease is defined as:

Score 4 or 5a with an increase in intensity of uptake from nadir
New FDG-avid foci consistent with lymphoma (may need biopsy or repeat scan if uncertain about etiology of foci).
Investigator assessed clinical progression

All participants who received at least one JCAR017 infusion

Posted

Median

Full Range

Months

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

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants

Secondary

Overall Survival (OS)

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

All participants who received at least one JCAR017 infusion

Posted

Median

Full Range

Months

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

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

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

qPCR PK Analysis Set

Posted

Geometric Mean

Geometric Coefficient of Variation

day*copies/μg

28days after first dose

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Blood Concentration (Cmax)

qPCR PK Analysis Set

Posted

Geometric Mean

Geometric Coefficient of Variation

copies/μg

28days after first dose

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Time of Maximum Observed Blood Concentration (Tmax)

qPCR PK Analysis Set

Posted

Median

Full Range

days

28days after first dose

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

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

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

Posted

Mean

Standard Deviation

Scores on a Scale

From Enrollment to end of follow up, approximately 26 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants

Secondary

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

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

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

Posted

Mean

Standard Deviation

Score on a Scale

Post Dose Month 24

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Secondary

Number of Intensive Care Unit (ICU) Inpatient Days and Non-ICU Inpatient Days and Reasons for Hospitalization

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

Liso-cel-treated Analysis Set - Inpatient Monitored

Posted

Median

Full Range

days

From first hospitalization to the last. Approximately 31 days

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Received Transfusions

Number of participants who received transfusions

Posted

Count of Participants

Participants

From first dose to end of treatment period approximately 24 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Number of Participants Requiring Growth Factor Support.

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

Posted

Count of Participants

Participants

From first dose to end of treatment period approximately 24 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Secondary

Number of Participants Requiring Intravenous Immunoglobulin (IVIG) Support

Number of participants requiring intravenous immunoglobulin (IVIG) support

Posted

Count of Participants

Participants

From first dose to end of treatment period approximately 24 months

ID	Title	Description
OG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lisocabtagene Maraleucel (JCAR017)	Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells/infusion) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.	48	82	48	82	82	82

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0005 affected82 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected82 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected82 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Vision blurred	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Gait disturbance	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected82 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG00024 affected82 at risk
Atypical pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected82 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 affected82 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Urosepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected82 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Aphasia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Cognitive disorder	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected82 at risk
Demyelinating polyneuropathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Disturbance in attention	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected82 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected82 at risk
Memory impairment	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Seizure	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected82 at risk
Slow speech	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Somnolence	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Tremor	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected82 at risk
Agitation	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Anxiety	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Confusional state	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected82 at risk
Delirium	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Disorientation	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Mental status changes	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected82 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00028 affected82 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00036 affected82 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00017 affected82 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00055 affected82 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00029 affected82 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0007 affected82 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00019 affected82 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00019 affected82 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00021 affected82 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 affected82 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0009 affected82 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG00025 affected82 at risk
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG00010 affected82 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00012 affected82 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG00010 affected82 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0007 affected82 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0005 affected82 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00019 affected82 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0007 affected82 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00011 affected82 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected82 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0008 affected82 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00016 affected82 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00011 affected82 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 affected82 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0008 affected82 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00013 affected82 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00020 affected82 at risk
Lethargy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected82 at risk
Tremor	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0008 affected82 at risk
Agitation	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0005 affected82 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0009 affected82 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 affected82 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected82 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00010 affected82 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0009 affected82 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0007 affected82 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00010 affected82 at risk

First MCP Posted Date

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D016393	Lymphoma, B-Cell
D016403	Lymphoma, Large B-Cell, Diffuse
D009369	Neoplasms
D009370	Neoplasms by Histologic Type
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D012008	Recurrence

Units	Counts
Participants	OG00082

ID	Term
D006425	Hemic and Lymphatic Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms