MCARH125 / Memorial Sloan-Kettering Cancer Center - LARVOL DELTA

Concurrent Administration of BCMA and GPRC5D Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Relapsed or Refractory Multiple Myeloma: Results from the Phase I TANDEMM Clinical Trial (IMS 2025) - "However, relapses are common and multi-antigen targeting has been proposed as a potential approach to achieve durable responses. We conducted a phase I, dose escalation trial of concurrent infusion of BCMA and GPRC5D CAR T cells, MCARH125 and MCARH109 in patients with relapsed or refractory myeloma. All patients received lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by CAR T cell infusion at one of 3 dose levels (DL): DL 0, 150 X 106 cells of MCARH125 alone; DL 1, 50 X106 cells of MCARH109 and 150 X 106 cells of MCARH125; DL 2, 150 X106 cells of MCARH109 and 150 X 106 cells of MCARH125... In this proof-of-concept trial, we demonstrate feasibility, safety, and efficacy of concurrently targeting two myeloma specific antigens BCMA and GPRC5D by co-administering two different CAR T products manufactured from a single apheresis."

Clinical • IO biomarker • P1 data • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Inflammation • Multiple Myeloma • CD8

A Study of MCARH109 and MCARH125 in People With Multiple Myeloma (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • SDC1

A Study of MCARH109 and MCARH125 in People With Multiple Myeloma (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Active, not recruiting | N=24 ➔ 15

Enrollment change • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology • SDC1

A Study of MCARH109 and MCARH125 in People With Multiple Myeloma (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • SDC1