Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT04684147 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-08-08
Summary
The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.
Conditions
- Relapsed or Refractory Acute Lymphoblastic Leukemia
Interventions
- BIOLOGICAL
-
single dose of CNCT19
Dose: 0.5 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Sponsors & Collaborators
-
Juventas Cell Therapy Ltd.
lead INDUSTRY
Principal Investigators
-
Jianxiang Wang, Dr. · Institute of Hematology & Blood Diseases Hospital, China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-24
- Primary Completion
- 2022-09-22
- Completion
- 2026-12-31
Countries
- China
Study Locations
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