NCT05846737

BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT

Safety and Efficiency of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT: a Prospective, Single-arm, Single-center, Phase II Study.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a open-label, single-center Phase 2 study to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. A total of 40 subjects will be enrolled into this study.

Detailed description

The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. Patients with detectable MRD after undergoing ASCT MRD will be enrolled in this study.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	anti-BCMA CAR-T	Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10\^6 anti-BCMA CAR+T cells/kg.

Timeline

• Start date: 2023-05-29
• Primary completion: 2025-05-01
• Completion: 2028-05-01
• First posted: 2023-05-06
• Last updated: 2024-07-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study