A Phase I Study of MCARH109 and MCARH125 CAR T-Cell Therapy in People with Multiple Myeloma

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Full Title

Phase I Trial of Concurrent Administration of GPRC5D Targeted CAR T Cell MCARH109 and BCMA Targeted CAR T Cell MCARH125 in Patients with Relapsed or Refractory Multiple Myeloma

Purpose

The purpose of this study is to assess the safety of giving the investigational drug MCARH125 alone and with MCARH109 to people with multiple myeloma that has come back or continued to grow despite treatment. Giving these treatments in combination may be more effective than either therapy alone.

MCARH125 and MCARH109 are types of CAR T-cell therapy, a type of cellular immunotherapy. With CAR T-cell therapy, white blood cells called T cells are removed from the patient, altered in the laboratory to recognize a protein on the patient’s cancer cells, multiplied to larger numbers, and returned to the patient to find and destroy cancer cells.

MCARH125 targets a protein called BCMA on myeloma cells and MCARH109 targets the GPRC5D protein. The treatments in this study are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have multiple myeloma that has come back or continued to grow despite at least three prior regimens of treatment.
  • The serious side effects of previous therapies should go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Sham Mailankody at 646-608-3712.

Protocol

22-052

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05431608