A Phase I Study of KITE-585 CAR T-Cell Therapy in Patients with Recurrent or Persistent Multiple Myeloma

Full Title

KITE-585-501: A Phase 1 Multicenter Study of KITE-585, an Autologous Anti-BCMA CAR T-Cell Therapy, in Subjects with Relapsed/Refractory Multiple Myeloma

Purpose

CAR T-cell therapy is a form of immunotherapy where immune cells called T cells are removed from a patient, modified in the laboratory to recognize the patient’s cancer cells, grown to larger quantities, and returned to the patient to mount an immune attack against the cancer. CAR T-cell therapy is currently approved by the U.S. Food and Drug Administration to treat some patients with lymphoma and leukemia. In this study, researchers are evaluating the safety of a new form of CAR T-cell therapy, called KITE-385, in patients with multiple myeloma that has come back or continued to grow despite prior treatment.

The modified T cells in KITE-385 therapy are designed to bind to and kill cells that express B-cell maturation antigen (BCMA), a molecule that is found on multiple myeloma cells. Patients will receive KITE-385 after they have received three days of chemotherapy with the drugs fludarabine and cyclophosphamide. The treatments used in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or persistent multiple myeloma after at least three regimens of therapy that included pomalidomide and/or daratumumab.
  • Patients’ myeloma must have continued to grow within 60 days of the last dose of therapy.
  • Patients who have had prior CAR T-cell therapy, BCMA-directed therapy, or allogeneic stem cell transplantation may not participate.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sergio Geralt at 212-639-3859.

Protocol

18-089

Phase

I

Investigator