Clinical Trial

Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated December 2, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a phase I, open label study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of allogeneic, CD19-directed Chimeric Antigen Receptor T (alloCAR-T) cells in pediatric and young adults patients with relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-10-10; most recent amendment 2025-11-25.
Status change: Not Yet Recruiting → Recruiting 2024-05-28
Trial Details
NCT Number NCT06080191
Lead Sponsor Bambino Gesù Hospital and Research Institute
Conditions B-cell Acute Lymphoblastic Leukemia
Enrollment 24 participants
Start Date 2024-04-28
Primary Completion 2026-06-30 (estimated)
Study Completion 2041-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-02