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NOT YET RECRUITING
NCT07077330
EARLY_PHASE1

CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms.

Official title: A Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T Cell Therapy for Relapsed/Refractory Plasma Cell Neoplasms

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-08-01

Completion Date

2027-08-01

Last Updated

2025-07-22

Healthy Volunteers

No

Interventions

OTHER

CAR19BCMA-T cells

CAR19BCMA-T cells Each subject will be infused with single dose of CD19BCMA-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 Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg

Locations (2)

The Four Medical Center of PLA General Hospital, China

Beijing, China

The Six Medical Center of PLA General Hospital, China

Beijing, China