NCT07249073

CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma

Exploratory Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

1. Objective to evaluate the safety and tolerability of CAR19-BCMA dual-target CAR-T in the treatment of relapsed / refractory multiple myeloma. 2. To determine the maximum tolerated dose (MTD) of car19-bcma dual target car-t in the treatment of relapsed / refractory multiple myeloma.

Detailed description

This study is an open, single arm, prospective, phase I clinical study, using "3+3" dose escalation to explore the safety, maximum tolerated dose, in vivo pharmacokinetic characteristics and preliminary efficacy of CAR19-BCMA dual-target CAR-T cell injection in the treatment of relapsed / refractory multiple myeloma subjects.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	CAR19-BCMA dual-target CAR-T	This drug is CAR-T cell injection. CAR-T cells are based on the traditional CAR-T treatment, using cytokine combination amplification and improved transfection technology to change the activation mode of T cells.

Timeline

• Start date: 2025-03-28
• Primary completion: 2028-03-27
• Completion: 2029-03-27
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: China