drugset / Trial / NCT03338972

Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma

NCT03338972 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating patients with BCMA positive multiple myeloma that has come back or does not respond to treatment. T cells are a type of white blood cell and a major component of the immune system. T-cells that have been genetically modified in the laboratory express BCMA and may kill cancer cells with the protein BCMA on their surface. Giving chemotherapy before BCMA CAR-T cells may reduce the amount of disease and to cause a low lymphocyte (white blood cell) count in the blood, which may help the infused BCMA CAR-T cells survive and expand.

Timeline

Start
2017-11-29
Primary completion
2021-05-03
Completion
2022-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject FCARH143 Cell therapy 5e+07 cells Intravenous
Subject FCARH143 Cell therapy 1.5e+08 cells Intravenous
Subject FCARH143 Cell therapy 3e+08 cells Intravenous
Subject FCARH143 Cell therapy 4.5e+08 cells Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous

Indications