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

NCT06986434 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Affiliated Hospital to Academy of Military Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-02
Primary Completion
2027-05-22
Completion
2028-08-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06986434 on ClinicalTrials.gov