A Phase 1 Study of 19-28z/IL-18 CAR T Cell Therapy in People With Acute Lymphoblastic Leukemia

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Full Title

A Phase I Trial of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells That Constitutively Secrete Interleukin 18 (19-28z/IL-18) in Patients with Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL)

Purpose

Researchers are assessing a CAR T cell therapy to treat acute lymphoblastic leukemia (ALL) that keeps growing even with treatment. With CAR T cell therapy, some of your own T cells (a type of white blood cell) are removed. They are genetically modified (changed) in a lab to recognize your own cancer cells. The altered T cells, called CAR T cells, are then returned to your body to find and kill cancer cells. This treatment is a form of immunotherapy.

The CAR T cell therapy in this study is called 19-28z/IL-18. The modified T cells recognize a protein on cancer cells called CD19. They release another protein called IL-18 that may increase the effectiveness of the CAR T cells.

Before you get 19-28z/IL-18, you may receive fludarabine and cyclophosphamide. These chemotherapy drugs briefly weaken your immune system and help prepare your body to receive the CAR T cells. The treatments in this study are given intravenously (by vein).

Who Can Join

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

  • Have ALL that came back or keeps growing after treatment and has the CD19 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 12 or older.

Contact

For more information and to see if you or your child can join this study, please call Dr. Jae Park’s office at 888-675-2278 (CART). 

Protocol

23-307

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06287528