CD19-targeted CAR T Cells (JWCAR029) for Primary Refractory Diffuse Large B Cell Lymphoma
NCT04812691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2023-11-22
Summary
This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China
Conditions
Interventions
- BIOLOGICAL
-
JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive 1 x 10\^8 CAR+T cells (JWCAR029) treatment by intravenous (IV) injection.
Sponsors & Collaborators
-
Shanghai Ming Ju Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Weili Zhao · Ruijin Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-10
- Primary Completion
- 2021-06-30
- Completion
- 2023-04-25
Countries
- China
Study Locations
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