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)

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