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

A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)

This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.

Study Overview

• Status: Completed
• Conditions: Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, Nonhodgkin
• Intervention / Treatment: Biological: lisocabtagene maraleucel

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
    • Gilbert, Arizona, United States, 85234
      • Local Institution - 0043
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Los Angeles, California, United States, 90095
      • UNC School of Medicine
    • Sacramento, California, United States, 95816
      • Sutter Medical Center
    • Sacramento, California, United States, 95816
      • Sutter Hematology and Oncology
    • Stanford, California, United States, 94305
      • Stanford Cancer Center
    • Stanford, California, United States, 94304
      • Stanford Cancer Genetics Clinic
    • Stanford, California, United States, 94305
      • Local Institution - 0092
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • The Blood and Marrow Transplant Group of Georgia
    • Atlanta, Georgia, United States, 30342
      • UNC School of Medicine
    • Atlanta, Georgia, United States, 30342
      • Local Institution - 0019
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60637
      • University of Chicago Comprehensive Cancer Center
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago
    • Chicago, Illinois, United States, 60611
      • Local Institution - 0003
    • Chicago, Illinois, United States, 60637-1470
      • Local Institution - 0016
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky/Markey Cancer Center
    • Lexington, Kentucky, United States, 40536
      • Local Institution - 0046
    • Louisville, Kentucky, United States, 40241
      • Norton Cancer Institute - Brownsboro
    • Louisville, Kentucky, United States, 40241
      • UNC School of Medicine
    • Louisville, Kentucky, United States, 40241
      • Local Institution - 0064
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21231
      • Local Institution - 0009
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Oncology Center Bunting Blaustein Building
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Regional Cancer Care Associates
    • East Brunswick, New Jersey, United States, 08816
      • Local Institution - 0052
    • East Brunswick, New Jersey, United States, 08816
      • UNC School of Medicine
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology P.C.
    • Albany, New York, United States, 12208
      • New York Oncology Hematology - Albany Cancer Center
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester Cancer Center
    • Rochester, New York, United States, 14642
      • Local Institution - 0090
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Charlotte, North Carolina, United States, 28204
      • Local Institution - 0021
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Oncology Hematology Care, Inc.
    • Cincinnati, Ohio, United States, 45236
      • Oncology Hematology Care
    • Cincinnati, Ohio, United States, 45236
      • Local Institution - 0039
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97213
      • Local Institution - 0051
    • Portland, Oregon, United States, 97213
      • Providence Cancer Center/Earle A. Chiles Res. Inst.
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center Hillman Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • Local Institution - 0029
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Health System
    • Greenville, South Carolina, United States, 29615
      • Local Institution - 0037
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System - Cancer Institute - Faris Road
  • Texas
    • Dallas, Texas, United States, 75390-7208
      • Local Institution - 0083
    • Dallas, Texas, United States, 75390
      • UNC School of Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • Intermountain Healthcare - LDS Hospital Blood and Marrow Transplant
    • Salt Lake City, Utah, United States, 84143
      • Local Institution - 0074
    • Salt Lake City, Utah, United States, 84143
      • Intermountain Healthcare - LDS Hospital
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties
    • Tacoma, Washington, United States, 98405
      • UNC School of Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin, Froedtert Hospital
    • Milwaukee, Wisconsin, United States, 53226
      • UNC School of Medicine
    • Milwaukee, Wisconsin, United States, 53226
      • Local Institution - 0055

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Confirmation of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS; de novo or transformed follicular lymphoma [tFL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma [DHL/THL]), and follicular lymphoma Grade 3B per WHO 2016 classification
• Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent
• Subjects must be deemed ineligible for both high-dose chemotherapy and hematopoietic stem cell transplant (based on age, performance status and/or comorbidities) while also having adequate organ function for CAR T cell treatment.
• Positron emission tomography (PET)-positive disease
• Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
• ECOG performance status of 0, or 1, or 2
• Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)
• Subjects must agree to use appropriate contraception
• Subjects must agree to not donate blood, organs, semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy

Exclusion Criteria:

• Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
• History of another primary malignancy that has not been in remission for at least 2 years.
• Previous treatment with CD19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment
• Active hepatitis B or hepatitis C infection at the time of screening
• History of or active human immunodeficiency virus (HIV) infection at the time of screening
• Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration
• History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
• History or presence of clinically relevant CNS pathology
• Pregnant or nursing women
• Subject does not meet protocol-specified washout periods for prior treatments
• Prior hematopoietic stem cell transplant
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Lisocabtagene maraleucel at a dose of 100×10^6 CAR+ T cells (50×10^6 CD8+ CAR+ T cells and 50×10^6 CD4+ CAR+ T cells), will be given IV in a single-dose schedule on Day 1 (between 2 and 7 days following the completion of lymphodepleting chemotherapy).	Biological: lisocabtagene maraleucel; lisocabtagene maraleucel will be administered as a single dose intravenous (IV) injection; Other Names: JCAR017; liso-cel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment. CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment. PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.	From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)	A TEAE was defined as an adverse event that started any time from initiation of product administration through and including 90 days following product administration. AEs that occurred after the initiation of subsequent anticancer therapy or product retreatment were not considered as product TEAE. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe, Grade 4= Life-threatening, and 5 = Death.	From first dose to 90 days following first dose (up to approximately 90 days)
Change From Baseline of Hematology Laboratory Results: Hemoglobin	Change from baseline in Hematology laboratory analysis. Includes Hemoglobin. Baseline is the last observation collected prior to or on the date of product infusion.	Baseline and Day 29
Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets	Change from baseline in Hematology laboratory analysis. Includes Leukocytes, Lymphocytes, Neutrophils, and Platelets. Baseline is the last observation collected prior to or on the date of product infusion.	Baseline and Day 29
Change From Baseline of Chemistry Laboratory Results: Albumin	Change from baseline in Chemistry laboratory analysis. Includes Albumin. Baseline is the last observation collected prior to or on the date of product infusion.	Baseline and Day 29
Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase	Change from baseline in Chemistry laboratory analysis. Includes Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase. Baseline is the last observation collected prior to or on the date of product infusion.	Baseline and Day 29
Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate	Change from baseline in Chemistry laboratory analysis. Includes Bilirubin, Creatinine, Direct Bilirubin, and Urate. Baseline is the last observation collected prior to or on the date of product infusion.	Baseline and Day 29
Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium	Change from baseline in Chemistry laboratory analysis. Includes Calcium Corrected, Magnesium, Phosphate, Potassium, and Sodium. Baseline is the last observation collected prior to or on the date of product infusion.	Baseline and Day 29
Complete Response (CR) Rate	Complete response rate (CRR) was defined as the percent of participants with a best overall response (BOR) of complete response (CR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment. CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.	From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplant (up to approximately 24 months)
Duration of Response (DOR)	Duration of response (DOR) is defined as the time from first complete response(CR) or partial response (PR) to progressive disease (PD) or death, whichever occurred first. CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment. PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.	From first dose to up to approximately 24 months
Duration of Response (DOR) in Participants With Complete Response (CR)	DOR for participants with a best overall response of CR was defined as the time from documentation of first response (or CR) to progressive disease (PD) or death, whichever occurred first. The first documentation of CR/PR is the latest of all dates of required measurements to establish the response. The progression date is the earliest date of all assessments that led to a response assessment of PD. CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.	From first dose to up to approximately 24 months
Progression-Free Survival (PFS)	PFS is defined as the time from JCAR017 infusion to progressive disease (PD) or death. Kaplan-Meier (KM) methodology will be used to analyze PFS. PD = Score 4 or 5b on the positron emission tomography 5-point scale (PET 5PS) with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.	From first dose to progressive disease (PD) or death (up to approximately 24 months)
Event-Free Survival (EFS)	EFS is defined as the time from JCAR017 infusion to the earliest of the following events: death from any cause, progressive disease (PD), or starting a new anticancer therapy. Kaplan-Meier (KM) methodology will be used to analyze EFS. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.	From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months)
Overall Survival (OS)	OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS.	From first dose to date of death (up to approximately 24 months)
PK Parameters of JCAR017 in Blood as Assessed by qPCR: Cmax	Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Cmax = Maximum observed blood concentration.	From first dose to up to 24 months
PK Parameters of JCAR017 in Blood as Assessed by qPCR: Tmax	Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood concentration.	From first dose to up to 24 months
PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)	Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.	From first dose to up to 24 months
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Symptom scale/item higher score represents a high level of symptomatic problem.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health/QoL Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Symptom scale/item higher score represents a high level of symptomatic problem.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea/Vomiting Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Symptom scale/item higher score represents a high level of symptomatic problem.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Symptom scale/item higher score represents a high level of symptomatic problem.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Symptom scale/item higher score represents a high level of symptomatic problem.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Symptom scale/item higher score represents a high level of symptomatic problem.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Symptom scale/item higher score represents a high level of symptomatic problem.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Symptom scale/item higher score represents a high level of symptomatic problem.	Baseline and Day 29
Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties Subscale	Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.; The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.; All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.; Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.	Baseline and Day 29
Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale	The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale.	Baseline and Day 29
Health-Related Quality of Life (HRQoL) Assessed by the 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. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-5L health states ranged from -.594 for the worst (55555) to 1 for the best (11111) for UK value set with an optimal health state is assigned a score of 1.00, death is assigned a score of 0.00 and negative values representing values as worse than dead. A change of .08 is considered to be a clinically meaningful change in health utility.	Baseline and Day 29
Numbers of Intensive Care Unit (ICU) Inpatient Days	The numbers of ICU inpatient days.	From first dose after JCAR017 infusion to up to approximately 24 months
Numbers of Non-intensive Care Unit (ICU) Inpatient Days	Number of non-ICU inpatient days.	From first dose after JCAR017 infusion to up to approximately 24 months
The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other	Length of hospitalization stay was reported for up to 24 months post liso-cel infusion. Reasons for hospitalization include adverse events, prophylaxis, and other. Adverse events were reported for up to 90 days post liso-cel infusion.	From first dose after JCAR017 infusion to up to approximately 24 months

Collaborators and Investigators

• Sponsor: Juno Therapeutics, a Subsidiary of Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
• Sehgal A, Hoda D, Riedell PA, Ghosh N, Hamadani M, Hildebrandt GC, Godwin JE, Reagan PM, Wagner-Johnston N, Essell J, Nath R, Solomon SR, Champion R, Licitra E, Fanning S, Gupta N, Dubowy R, D'Andrea A, Wang L, Ogasawara K, Thorpe J, Gordon LI. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022 Aug;23(8):1066-1077. doi: 10.1016/S1470-2045(22)00339-4. Epub 2022 Jul 12.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Actual): September 24, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: immunotherapy; CAR T cell; NHL; cell therapy; JCAR017; CAR; chimeric antigen receptor; liso-cel; autologous T cell therapy; lisocabtagene maraleucel
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: 017006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No