NCT06986434

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

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

• 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 CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms and lymphomas/leukemias with plasmacytic differentiation.

Detailed description

This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR19BCMA CAR-T cell. 20 subjects with relapsed or refractory CD19/ BCMA positive positive plasma cell neoplasms and lymphomas/leukemias with plasmacytic differentiation will be enrolled and received CAR19BCMA CAR T cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. To evaluate its safety and efficacy.

Conditions

• Relapsed or Refractory Plasma Cell Neoplasms
• Lymphomas/Leukemias With Plasmacytic Differentiation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-02
• Primary completion: 2027-05-22
• Completion: 2028-08-25
• First posted: 2025-05-23
• Last updated: 2026-04-08

Locations

1 site across 1 country: China