A Phase 1 Study of CD371-Targeting CAR T Cell Therapy in People With Acute Myeloid Leukemia

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Full Title

Phase I Trial of CLEc12a (CD371) targeted ArmoRed immune effector cells in Patients with Relapsed/Refractory Acute Myeloid Leukemia (CLEAR-AML)

Purpose

MSK researchers are studying a new CAR T cell therapy to treat acute myeloid leukemia (AML). They want to evaluate its safety and find the best dose of the new treatment. The adults and children in this study have AML that keeps growing even after treatment. The new CAR T cell therapy is called CD371-CAR-IL18.

With CAR T cell therapy, some of your immune cells called T cells are removed and changed in a lab. They are trained to find and kill cancer cells in your body that have a certain protein on them. With the treatment in this study, the T cells are trained to find cancer cells with the CD371 protein. The new T cells are then multiplied in the lab and returned to your body to fight cancer.

In addition to targeting CD371, CD371-CAR-IL18 is different from other CAR T cell therapies. It is designed to help CAR T cells work better and for longer to kill cancer cells. The T cells also make a protein called IL-18. This protein may further help the patient’s immune system to destroy cancer cells. CD371-CAR-IL18 is given intravenously (by vein).

Who Can Join

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

  • Have AML that came back or keeps growing after treatment.
  • Have AML that has the CD371 protein.
  • 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 1 year or older. Please note that the first group of patients to be enrolled will be over age 16. Then younger patients will be enrolled. 

Contact

For more information or to see if you can join this study, please call Dr. Mark Geyer’s office at 646-608-2091. If you are interested in this study for your child, please call Dr. Kevin J. Curran’s office at 212-639-5836.

Protocol

23-016

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

ClinicalTrials.gov ID

NCT06017258