Non Hodgkin Lymphoma Clinical Trial
A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)
This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up to 2 years.
This is an open-label, multicenter, Phase 2 study to assess the safety and antitumor activity in adult patients with relapsed or refractory B-cell non-Hodgkin Lymphoma when administered with lisocabtagene maraleucel (JCAR017) in the outpatient setting.
Upon the successful product generation of lisocabtagene maraleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by lisocabtagene maraleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, health-related quality of life (HRQoL), and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, per health regulatory authority guidelines, currently up to 15 years after the last lisocabtagene maraleucel administration.
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.
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
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There are 23 Locations for this study
Los Angeles California, 90048, United States
Denver Colorado, 80218, United States
Miami Florida, 33176, United States
Orlando Florida, 32804, United States
Indianapolis Indiana, 46237, United States
Wichita Kansas, 67124, United States
Louisville Kentucky, 40207, United States
Southfield Michigan, 48075, United States
East Brunswick New Jersey, 08816, United States
Morristown New Jersey, 07962, United States
Albany New York, 12208, United States
Cincinnati Ohio, 45236, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97213, United States
Lancaster Pennsylvania, 17604, United States
Greenville South Carolina, 29615, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
San Antonio Texas, 78229, United States
Temple Texas, 76508, United States
Tyler Texas, 75702, United States
Salt Lake City Utah, 84143, United States
Norfolk Virginia, 23502, United States
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