A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
NCT05667506 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2025-08-12
Summary
This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
Conditions
Interventions
- BIOLOGICAL
-
single dose of CNCT19
Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously. Lymphodepletion treatment: Drugs:Fludarabine Drugs: Cyclophosphamide
Sponsors & Collaborators
-
Juventas Cell Therapy Ltd.
lead INDUSTRY
Principal Investigators
-
Xiaofan Zhu, M.D · Institute of Hematology & Blood Diseases Hospital, China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-07
- Primary Completion
- 2025-05-30
- Completion
- 2027-05-30
Countries
- China
Study Locations
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