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)
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.
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