NCT05509530

Safety and Efficacy of Anti-BCMA/GPRC5D CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma(rr/MM)

Efficacy and Safety Study of Anti-BCMA/GPRC5D CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA/GPRC5D CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture Anti-BCMA/GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/GPRC5D infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Detailed description

This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-BCMA/GPRC5D CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture Anti-BCMA/GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/GPRC5D infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	anti-BCMA/GPRC5D CAR-T CELL	anti-BCMA/GPRC5D autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10\^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2022-08-22
• Last updated: 2022-08-22

Locations

1 site across 1 country: China