At a glance
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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
In Brief
A Phase 1 clinical trial evaluating Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143, Cyclophosphamide, and 2 other interventions for Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma. Completed, enrolled 28 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV
Undergo leukapheresis