NCT07139509

Allogeneic UCB-derived, Dual-targeting BCMA/CD19 CAR-T for Relapsed/Refractory Multiple Myeloma

Clinical Study on the Safety and Tolerability of Allogeneic, Umbilical Cord Blood-derived, Dual-targeting BCMA/CD19 CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Xi'an No.3 Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to learn if allogeneic cord blood-derived CAR-T cell drug works to treat Multiple Myeloma (MM) including Bone-related extramedullary (EMB) disease and extramedullary extraosseous disease(EME) in adults. It will also learn about the safety of the allogeneic cord blood-derived CAR-T cell drug. The main questions it aims to answer are: 1. What adverse events occur and the incidence rate of DLTs within 28 days and UCAR-T-related AEs within 28 days after the allogeneic cord blood-derived CAR-T cell injection for multiple myeloma (MM)? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the overall responserate (ORR), including stringent complete response (sCR), completeresponse (CR),very good partial response (VGPR), partial response (PR), minimal Response (MR) and DOR, PFS, RFS, OS? Participants will: 1. be pretreated with FC regimen, fludarabine (30mg/m²/d, days -5, -4, and -3) and cyclophosphamide (300\~500 mg/m²/d, day -5,-4, and -3). 2. rest for 2 days on Day-2 and Day-1. Tumor burden should be re-evaluated and chemotherapy side effects assessment. 3. receive allogeneic cord blood-derived CAR-T cells infusion 4. Visit the clinic at D28, 1 month, 2 months, 3 months, 4 months, 6 months, 9 months and 1 year after CAR-T cells infusion.

Conditions

• Relapsed/Refractory Multiple Myeloma(MM)

Interventions

Type	Name	Description
DRUG	allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells	dosage form: UCAR-T cell injection Route of Administration: Single intravenous injection Participants will receive lymphodepletion with fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) from Day -5 to -3, prior to UCAR-T cell infusion on Day 0.

Timeline

• Start date: 2024-10-03
• Primary completion: 2028-07-30
• Completion: 2028-12-30
• First posted: 2025-08-24
• Last updated: 2025-11-25

Locations

1 site across 1 country: China