NCT07416682

CAR BCMA-70 CAR-T Cells for the Treatment of High-risk Plasma Cell Neoplasms

Clinical Study on the Safety and Efficacy of CAR BCMA-CD70 Dual-target CAR-T Therapy for High-risk Plasma Cell Neoplasms

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.

Conditions

• High-risk Plasma Cell Neoplasms

Interventions

Type	Name	Description
GENETIC	CAR BCMA-CD70-T cells	Each subject will be infused with single dose of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10\^6 /kg, the medium dose is 2×10\^6 /kg, and the high dose is 3×10\^6 /kg.
DRUG	fludarabine and cyclophosphamide	Description: Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells.

Timeline

• Start date: 2026-01-31
• Primary completion: 2027-01-30
• Completion: 2028-01-30
• First posted: 2026-02-18
• Last updated: 2026-02-25

Locations

1 site across 1 country: China