NCT06644443

BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma

BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma：A Prospective, Single-center, Single-arm Phase I/IIa Clinical Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shenzhen University General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.

Detailed description

Multiple myeloma (MM) is a hematological malignant tumor characterized by clonal proliferation of abnormal plasma cells in the bone marrow. The incidence of MM is mainly in the middle and old age, and the incidence of MM in China has increased in recent years. At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Recurrent or refractory MM is still a thorny problem in the treatment of MM, which is an important factor for the survival of patients.Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.

Conditions

• Multiple Myeloma in Relapse

Interventions

Type	Name	Description
BIOLOGICAL	BCMA-GPRC5D CAR-T cells	patient was subjected to 2-5×10\^6 BCMA-GPRC5D CAR-T cells/kg

Timeline

• Start date: 2023-07-15
• Primary completion: 2025-07-14
• Completion: 2026-07-14
• First posted: 2024-10-16
• Last updated: 2024-10-16

Locations

1 site across 1 country: China