A Phase 1 Study of CB-011 CAR T Cell Therapy in People With Multiple Myeloma

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Full Title

A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)

Purpose

Researchers want to find the best dose of CB-011 to treat multiple myeloma. The people in this study have multiple myeloma that keeps growing even after treatment.

CB-011 is made in a lab from white blood cells (called T cells) from an unrelated healthy person (donor). T cells are immune system cells. Some types of cancer can block T cells from attacking cancer cells. The donor T cells in CB-011 are modified (changed) in a lab so they can find and kill cancer cells. These modified T cells are called chimeric antigen receptor (CAR) T cells. Treatments made from them are called CAR T cell therapies.

CB-011 is given intravenously (by vein). If you join this study, you will first get cyclophosphamide and fludarabine to briefly weaken (suppress) your immune system. These two drugs prepare your body to receive CB-011.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have multiple myeloma that keeps growing or came back after at least 3 regimens of treatment.
  • Not have had prior CAR T cell therapy.
  • Have recovered from the serious side effects of previous treatments before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Sham Mailankody’s office at 646-608-2091.

Protocol

23-182

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05722418