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NOT YET RECRUITING
NCT06986434
EARLY_PHASE1

CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms and Lymphomas/Leukemias With Plasmacytic Differentiation

Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

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 and lymphomas/leukemias with plasmacytic differentiation.

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 and Lymphomas/Leukemias With Plasmacytic Differentiation

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-04-02

Completion Date

2028-08-25

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

GENETIC

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/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells.

Locations (1)

the Fifth Medical Center of Chinese People's Liberation Army General Hospital

Beijing, China