Study Evaluating the Safety and Efficacy of JWCAR029 in Adult Subjects With Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

Brief Summary: 

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult subjects with relapsed and refractory B-cell Non-Hodgkin lymphoma. 

Condition or disease：Non Hodgkin Lymphoma

Intervention/treatment：Biological: JWCAR029 

Phase：Phase 1 

Ages Eligible for Study: 18 Years and older   (Adult, Senior) 

Sexes Eligible for Study: All 

Accepts Healthy Volunteers: No 

Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled in this study: 

 - Age ≥ 18 years at the time of consent 

 - Signed written informed consent obtained prior to any study procedures 

 - Relapsed or refractory B-cell NHL. 

 - PET-positive disease BY Lugano classification 

 - Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable. 

 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 

 - Adequate bone marrow, renal, hepatic, pulmonary and cardiac 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 who meet any of the following criteria will be excluded from participation in this study: 

 - Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study) 

 - History of another primary malignancy that has not been in remission for at least 2 years. 

 - Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis 

 - Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of screening 

 - Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or JWCAR029 administration 

 - Presence of acute or chronic graft-versus-host disease (GVHD) 

 - History of cardiovascular disease 

 - History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis 

 - Pregnant or nursing women. 

 - Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JWCAR029 treatment in this protocol for subjects receiving retreatment