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DRUG:

FCARH143

i
Other names: FCARH143, autologous anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes, BCMA CAR-CD4+/CD8+ T-cells, BCMA-specific CAR-expressing CD4+/CD8+ T-lymphocytes, FCARH-143, FCARH 143
Associations
Company:
BMS, Fred Hutchinson Cancer Center, National Cancer Institute
Drug class:
BCMA-targeted CAR-T immunotherapy
Related drugs:
Associations
1year
Impact of Gamma-Secretase Inhibition on the Multiple Myeloma Immune Microenvironment (ASH 2023)
In a phase I, first-in-human clinical trial (n=18; relapsed/refractory MM) combining the GSI, crenigacestat, with anti-BCMA CAR T-cell therapy (FCARH143), we recently demonstrated that plasma cell BCMA antibody-binding capacity increased a median of 12-fold among 17/18 (94%) of participants after they received a 5-day GSI "run-in" (25 mg orally administered QOD for 3 doses) [Cowan AJ, et al...Accessibility of CD38, the target of daratumumab, was significantly increased in B cells, and SLAMF7, the target of elotuzumab, was significantly increased in plasma cells... BCMA cleavage from myeloma cells' surface is a putative resistance mechanism to BCMA-targeting immunotherapy. This study assessed the single-cell transcriptome and chromatin accessibility in the bone marrow environment of 16 patients given GSI monotherapy to ultimately enhance the efficacy of subsequent anti-BCMA CAR T-cell therapy. We found that prior BCMA-targeted therapy resulted in reduced chromatin accessibility within the BCMA epigenome.
IO biomarker
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NOTCH1 (Notch 1) • TNFRSF17 (TNF Receptor Superfamily Member 17) • NOTCH2 (Notch 2) • ERBB4 (erb-b2 receptor tyrosine kinase 4) • HES1 (Hes Family BHLH Transcription Factor 1) • SLAMF7 (SLAM Family Member 7)
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TNFRSF17 expression
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Darzalex (daratumumab) • Empliciti (elotuzumab) • FCARH143 • crenigacestat (LY3039478)
over2years
Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
P1, N=28, Completed, Fred Hutchinson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2037 --> Mar 2022
Trial completion • Trial completion date • CAR T-Cell Therapy
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SDC1 (Syndecan 1)
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cyclophosphamide • fludarabine IV • FCARH143