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DRUG:

MCARH109

i
Other names: MCARH109, GPRC5D CAR cells, MCARH-109, MCARH 109
Associations
Company:
BMS, Eureka Therap, Memorial Sloan-Kettering Cancer Center, Sanofi
Drug class:
GPRC5D-targeted CAR-T immunotherapy
Associations
2ms
MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma (clinicaltrials.gov)
P1, N=17, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
Trial completion date • Trial primary completion date
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SDC1 (Syndecan 1)
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MCARH109
4ms
A Study of MCARH109 and MCARH125 in People With Multiple Myeloma (clinicaltrials.gov)
P1, N=24, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
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SDC1 (Syndecan 1)
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MCARH109 • MCARH125
1year
Genetic Basis of Relapse after GPRC5D-Targeted CAR T Cells (ASH 2023)
Our patients with heavily pretreated multiple myeloma may harbor greater tumor heterogeneity and genomic instability than previously described, which can facilitate clonal outgrowth of antigen-negative tumor cells under continuous selective pressure of GPRCRD-targeted CAR T cells. Potential strategies to mitigate antigen escape-mediated relapse in myeloma patients receiving T-cell engaging therapies including earlier use of these therapies, multi-antigen targeting, or combination approaches are being evaluated in ongoing trials.
CAR T-Cell Therapy • IO biomarker
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GPRC5D (G Protein-Coupled Receptor Class C Group 5 Member D)
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GPRC5D expression
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MCARH109
2years
Clinical Activity of BMS-986393 (CC-95266), a G Protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)–Targeted Chimeric Antigen Receptor (CAR) T Cell Therapy, in Patients with Relapsed and/or Refractory (R/R) Multiple Myeloma (MM): First Results from a Phase 1, Multicenter, Open-Label Study (ASH 2022)
After screening and leukapheresis, pts received bridging therapy if needed, then lymphodepleting chemotherapy (fludarabine 30 mg/m2 + cyclophosphamide 300 mg/m2 daily for 3 days) followed by a single infusion of BMS-986393... At all tested dose levels, BMS-986393 demonstrated a favorable safety profile; both CRS and neurotoxicity were low-grade, and neurotoxicity was infrequent and short-lived. Dose escalation is ongoing; MTD has not been exceeded. Preliminary efficacy appeared promising; antitumor responses were observed, including pts with CR who were MRD-negative at month 3.
Clinical • P1 data • IO biomarker
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GPRC5D (G Protein-Coupled Receptor Class C Group 5 Member D)
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cyclophosphamide • fludarabine IV • BMS-986393 • MCARH109
over2years
MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma (clinicaltrials.gov)
P1, N=17, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Aug 2023 --> Aug 2024 | Trial primary completion date: Aug 2023 --> Aug 2024
Trial completion date • Trial primary completion date
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SDC1 (Syndecan 1)
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MCARH109
over2years
A Study of MCARH109 and MCARH125 in People With Multiple Myeloma (clinicaltrials.gov)
P1 | N=24 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center
CAR T-Cell Therapy • New P1 trial
|
MCARH109
almost3years
MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma (clinicaltrials.gov)
P1, N=17, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=36 --> 17
Enrollment closed • Enrollment change
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SDC1 (Syndecan 1)
|
MCARH109
over3years
MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma (clinicaltrials.gov)
P1, N=36, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Aug 2022 --> Aug 2023 | Trial primary completion date: Aug 2022 --> Aug 2023
Trial completion date • Trial primary completion date
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SDC1 (Syndecan 1)
|
MCARH109
4years
New P1 trial
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SDC1 (Syndecan 1)
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MCARH109