Status:
UNKNOWN
Study Evaluating the Safety and Efficacy of JWCAR029 in Adult Subjects With Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
Lead Sponsor:
Zhao Weili
Collaborating Sponsors:
Shanghai Mingju Biotechnology Co., Ltd.
Conditions:
Non Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03355859
Start Date
January 5 2018
End Date
March 1 2022
Last Update
July 12 2019
Active Locations (1)
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1
Ruijin hospital
Shanghai, Shanghai Municipality, China, 200025