Exploratory Study of CD19-targeted Chimeric Antigen Receptor T Cells(BZ019) for Relapsed and Refractory B-cell Lymphoma
NCT04067414 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-02-11
Summary
This is an open-label, multicenter, dose-escalation phase 1 study to determine the safety and efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma.
Conditions
- Diffuse Large B Cell Lymphoma
- High-grade B-cell Lymphoma
- Transformed Lymphoma
- Primary Mediastinal Large B Cell Lymphoma
Interventions
- BIOLOGICAL
-
BZ019
Subjects will be enrolled in three dose-groups: Dose 1: 1×10\^6/kg CAR+ cells; Dose 2: 3×10\^6/kg CAR+ cells; Dose 3: 6×10\^6/kg CAR+ cells.
Sponsors & Collaborators
-
Shanghai Cell Therapy Engineering Technology Research Center Group Co., Ltd.
collaborator UNKNOWN -
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Principal Investigators
-
Lugui Qiu, MD · Institute of Hematology & Blood Diseases Hospital, China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-08
- Primary Completion
- 2021-06-04
- Completion
- 2021-06-04
Countries
- China
Study Locations
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