NCT07256353

Allogeneic UCB-derived CAR-T for B-ALL

Clinical Study on the Safety and Efficacy of Allogeneic, Umbilical Cord Blood Derived CAR T-cell Therapy for B Cell Acute Lymphoblastic Leukemia

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The General Hospital of Western Theater Command · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the allogeneic, umbilical cord blood-derived CAR-T cell product. The main questions it aims to answer are: 1. What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and UCAR-T-related adverse events (AEs) after the UCAR-T cell infusion? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)? Participants will: 1. May receive lymphodepletion chemotherapy if clinically indicated: fludarabine (30 mg/m²/d, days -5, -4, and -3) and cyclophosphamide (300-500 mg/m²/d, days -5 and -4). 2. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. 3. Receive UCAR-T cells infusion on Day 0. 4. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 5. Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after UCAR-T cells infusion, with continued long-term follow-up for safety and persistence.

Conditions

• B-Cell Acute Lymphoblastic Leukemia, Adult

Interventions

Type	Name	Description
DRUG	allogeneic umbilical cord blood-derived CAR-T	intravenous injection of allogeneic umbilical cord blood-derived CAR-T

Timeline

• Start date: 2025-12-01
• Primary completion: 2030-12-31
• Completion: 2031-12-31
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

1 site across 1 country: China