A Study to See if Anti-BCMA CAR T-Cell Therapy Can Be Made from People with Multiple Myeloma Who Have Had a Stem Cell Transplant

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Full Title

Feasibility Trial of Autologous Anti-B Cell Maturation Antigen Chimeric Antigen Receptor T Cell Therapy for Multiple Myeloma Patients Status Post Hematopoietic Cell Transplantation

Purpose

With CAR T-cell therapy, some of a patient’s own T cells (a type of white blood cell) are removed and genetically modified in a laboratory to recognize their own cancer cells. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancer cells throughout the body. This approach is a form of immunotherapy.

The purpose of this study is to see if the quality of T cells used to make commercial CAR T-cell therapies affects how the CAR T cell prevents cancer from coming back in people with recurrent or persistent multiple myeloma who have had a stem cell transplant. The quality of T cells is dependent on when they were collected. T cells are considered to be high-quality when collected from stem cells (special cells that can develop into different cell types) around the time of the cancer diagnosis and/or from the donor’s cells before chemotherapy treatment.

Patients in this study will receive commercial CAR T cells directed against the BCMA protein on myeloma cells as part of their standard treatment. Researchers will collect samples of the patients’ blood and test the liquid part of the soft tissue inside their bones (bone marrow aspirate) before and after they receive CAR T cells. The investigators will then see how the quality of the T cells in these samples affects the way their cancers respond to CAR T cell treatment.

Who Can Join

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

  • Participants in this study must have multiple myeloma that has come back or persists despite treatment with four or more prior therapies that included a stem cell transplant.
  • 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.

For more information and to ask about eligibility for this study, please contact the office of Dr. Gunjan Shah at 212-639-8356.

Protocol

22-118

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

ClinicalTrials.gov ID

NCT05393804