NCT03338972: Phase 1 - Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143 in RRMM

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

NCT03338972: Phase 1 - Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma

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.

Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

Juno Therapeutics, Inc.

National Cancer Institute (NCI)

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ClinicalTrials.gov Identifier: NCT03338972

A Phase I Study of Adoptive Immunotherapy for Advanced B-Cell Maturation Antigen (BCMA)+ Multiple Myeloma With Autologous CD4+ and CD8+ T Cells Engineered to Express a BCMA-Specific Chimeric Antigen Receptor

First Posted : November 9, 2017

Click here for details on ClinicalTrials.gov

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Biological: Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143

Drug: Cyclophosphamide

Drug: Fludarabine

Other: Laboratory Biomarker Analysis

Procedure: Leukapheresis

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