- Active, not recruiting
NCT03338972: Phase 1 - Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143 in RRMM
Updated: Jun 15, 2022
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)
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
Biological: Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143
Drug: Cyclophosphamide
Drug: Fludarabine
Other: Laboratory Biomarker Analysis
Procedure: Leukapheresis
autologous anti-BCMA-CAR-expressing CD4+/CD8+ T lymphocytes FCARH143
autologous anti-BCMA-CAR CD4+/CD8+ cells
BCMA CAR-CD4+/CD8+ T cells
BCMA-specific CAR-expressing CD4+/CD8+ T lymphocytes
FCARH143
A preparation of ex vivo expanded autologous CD8+ and CD4+ T cells that have been genetically modified to express a chimeric antigen receptor (CAR) specific for human B-cell maturation antigen (BCMA; tumor necrosis factor receptor superfamily member 17; TNFRSF17), with potential immunostimulating and antineoplastic activities
653.Myeloma: Therapy, excluding Transplantation| November 13, 2019
Response to Bcma CAR-T Cells Correlates with Pretreatment Target Antigen Density and Is Improved By Small Molecule Inhibition of Gamma Secretase
- Washington: Fred Hutchinson Cancer Center Seattle
Location
United States, Washington