CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
NCT03671460 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2018-09-14
Summary
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Conditions
Interventions
- BIOLOGICAL
-
CD19 CAR-T cells
T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
Sponsors & Collaborators
-
Tianjin Mycure Medical Technology Co., Ltd
lead INDUSTRY
Principal Investigators
-
Peihua Lu, PhD,MD · Hebei Yanda Ludaopei Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-07
- Primary Completion
- 2020-01-01
- Completion
- 2021-01-01
Countries
- China
Study Locations
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