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)
Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, B-Cell
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Lisocabtagene maraleucel, liso-cel, JCAR017, relapse, refractory, B-Cell Non-Hodgkin Lymphoma, NHL, chimeric antigen receptor, CAR, CAR T cell, autologous T cell therapy, immunotherapy, cell therapy, B-cell malignancies
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
Sites / Locations
- Local Institution - 0057
- Local Institution - 0060
- Local Institution - 0089
- Local Institution - 0081
- Local Institution - 0065
- Local Institution - 0069
- Local Institution - 0064
- Local Institution - 0101
- Local Institution - 0052
- Local Institution - 0066
- Local Institution - 0041
- Local Institution - 0039
- Local Institution - 0098
- Local Institution - 0051
- Lancaster General Hospital
- Local Institution - 0037
- Local Institution - 0063
- Local Institution - 0097
- Local Institution - 0061
- Baylor Scott and White Health
- Local Institution - 0096
- Local Institution - 0074
- Local Institution - 0036
Arms of the Study
Arm 1
Experimental
Lisocabtagene maraleucel
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.