To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects With R/R B-ALL
NCT05651191 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2022-12-14
Summary
This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human CD19 targeted DASH CAR-T Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
Conditions
Interventions
- DRUG
-
Human CD19 Targeted DASH CAR-T Cells Injection
Autologous genetically modified anti-CD19 CAR transduced T cells
Sponsors & Collaborators
-
Second Affiliated Hospital of Nanchang University
collaborator OTHER -
Hrain Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Qingming Wang, M.D. · Second Affiliated Hospital of Nanchang University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-21
- Primary Completion
- 2024-09-30
- Completion
- 2025-09-30
Countries
- China
Study Locations
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