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

Completed · Phase 3

Conditions studied: Lymphoma, Non-Hodgkin

In brief

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B). All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT). Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event. Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.

Key facts

Study ID

NCT03575351

Run by

Celgene

People needed

184

Starts

2018-10-23

Expected to finish

2023-10-23

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥ 18 years and ≤ 75 years of age at the time of signing the informed consent form (ICF).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• Histologically proven diffuse large B-cell lymphoma (DLBCL) NOS (de novo or transformed indolent NHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma [DHL/THL]), primary mediastinal (thymic) large B-cell lymphoma (PMBCL), T cell/histiocyte-rich large B-cell lymphoma (THRBCL) or follicular lymphoma grade 3B. Enough tumor material must be available for confirmation by central pathology.
• Refractory or relapsed within 12 months from CD20 antibody and anthracycline containing first line therapy.
• [18F] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion at screening. (Deauville score 4 or 5)
• Adequate organ function
• Participants must agree to use effective contraception

You may not qualify if…

• Subjects not eligible for hematopoietic stem cell transplantation (HSCT).
• Subjects planned to undergo allogeneic stem cell transplantation.
• Subjects with, primary cutaneous large B-cell lymphoma, EBV (Epstein-Barr virus) positive DLBCL, Burkitt lymphoma or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter transformation).
• Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for ≥ 2 years with the exception of the following noninvasive malignancies:
• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative.
• Other completely resected stage 1 solid tumor with low risk for recurrence
• Treatment with any prior gene therapy product.
• Subjects who have received previous CD19-targeted therapy.
• Subjects with active hepatitis B, or active hepatitis C are excluded. Subjects with negative polymerase chain reaction (PCR) assay for viral load for hepatitis B or C are permitted. Subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy. Subjects with a history of or active human immunodeficiency virus (HIV) are excluded.
• Subjects with uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment.
• Active autoimmune disease requiring immunosuppressive therapy.
• History of any one of the following cardiovascular conditions within the past 6 months prior to signing the ICF: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.
• History or presence of clinically relevant central nervous system (CNS) pathology
• Pregnant or nursing (lactating) women.

Where it is running

• Local Institution - 116 — Scottsdale, Arizona, United States
• Local Institution - 115 — San Francisco, California, United States
• Local Institution - 106 — Aurora, Colorado, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Local Institution - 126 — Tampa, Florida, United States
• Local Institution - 108 — Atlanta, Georgia, United States
• Local Institution - 107 — Atlanta, Georgia, United States
• Local Institution - 122 — Chicago, Illinois, United States
• Loyola University Medical Center Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• Local Institution - 102 — Boston, Massachusetts, United States
• Local Institution - 104 — Boston, Massachusetts, United States
• Local Institution - 120 — Ann Arbor, Michigan, United States
• Local Institution - 119 — Detroit, Michigan, United States
• Local Institution - 112 — Minneapolis, Minnesota, United States
• Local Institution - 103 — Rochester, Minnesota, United States
• Local Institution - 100 — Omaha, Nebraska, United States
• Local Institution - 121 — Hackensack, New Jersey, United States
• Local Institution - 111 — Buffalo, New York, United States
• Local Institution - 117 — New York, New York, United States
• Local Institution - 125 — Charlotte, North Carolina, United States
• Local Institution - 127 — Oklahoma City, Oklahoma, United States
• Local Institution - 101 — Portland, Oregon, United States
• Local Institution - 123 — Pittsburgh, Pennsylvania, United States
• Local Institution - 109 — Dallas, Texas, United States
• Local Institution - 129 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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