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A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents

StatusRecruiting
PhasePhase 2
Started2022-01-26
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 48 months later Dec 31, 2024 → Dec 31, 2028
See other at-risk trials from Chongqing Precision Biotech Co., Ltd

Amendment history

2026-09-16
critical
Trial status changed: Unknown → Recruiting
Trial sites expanded: 10 → 16 locations
Primary completion pushed: 2024-12-31 → 2028-12-31
Completion pushed: 2025-07-01 → 2029-07-01
2026-08-02
minor
Trial status changed: Recruiting → Unknown
2024-07-30
notable
Recruiting→Unknown Study Status, Contacts/Locations v2
Trial statusRecruiting→Unknown
Primary completion date2023-12-31→2024-12-31
Study sitescontacts updated at 1 of 10 sites
2022-05-19
minor
Study Status, Contacts/Locations v1
Study sites1→10
2022-04-13
minor
Original filing
This is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
Trial Details
NCT Number NCT05334823
Lead Sponsor Chongqing Precision Biotech Co., Ltd
Conditions Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL, Refractory Acute Lymphoblastic Leukemia
Enrollment 100 participants
Start Date 2022-01-26
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-15