CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms and Lymphomas/Leukemias With Plasmacytic Differentiation
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
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.
Eligibility
Primary outcome measure(s)
- According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms and lymphomas/leukemias with plasmacytic differentiation. — up to 3 years
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria - According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms and lymphomas/leukemias with plasmacytic differentiation. — MTD will be determined based on DLTs observed during the first 28 days of study treatment
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| the Fifth Medical Center of Chinese People's Liberation Army General Hospital | Beijing | China |
More Affiliated Hospital to Academy of Military Medical Sciences trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06986434 on ClinicalTrials.gov ↗ ← All trials in China