Non Hodgkin Lymphoma Clinical Trial
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
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.
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
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.
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There are 53 Locations for this study
Scottsdale Arizona, 85258, United States
Scottsdale Arizona, 85259, United States
San Francisco California, 94143, United States
Aurora Colorado, 80045, United States
Jacksonville Florida, 32224, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60611, United States
Maywood Illinois, 60153, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Omaha Nebraska, 68198, United States
Hackensack New Jersey, 07601, United States
Buffalo New York, 14263, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15232, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98109, United States
Gent , 9000, Belgium
Lille , 59037, France
Marseille cedex , 13273, France
Pierre Benite , 69495, France
Villejuif CEDEX , 94805, France
Dresden Saxony, 01307, Germany
Berlin , 13125, Germany
Hamburg , 20246, Germany
Köln , 50937, Germany
Muenster , 48149, Germany
München , 81377, Germany
Rome , 00161, Italy
Rozzano (MI) , 20089, Italy
Torino , 10126, Italy
Osaka Osaka-shi, 545-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Minato-ku Tokyo, 105-8, Japan
Bunkyo-ku , 113-8, Japan
Rotterdam , 3075 , Netherlands
Barcelona , 08036, Spain
Madrid , 28041, Spain
Stockholm , SE-14, Sweden
Bern , 3010, Switzerland
London , WC1E , United Kingdom
Southampton , SO16 , United Kingdom
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