A Phase 1 Study of ADCLEC.syn1 CAR T Cell Therapy in People With Acute Myeloid Leukemia

Full Title

A Phase I Study of ADCLEC.syn1 CAR T cells in Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia

Purpose

Researchers want to find the best dose of ADCLEC.syn1 that can be used in people with leukemia. The people in this study have acute myeloid leukemia (AML) that keeps growing even after treatment. There are currently no FDA-approved CAR T cell therapies for AML.

ADCLEC.syn1 is a type of immunotherapy called CAR T cell therapy. 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 specific proteins on your leukemia cells. The altered T cells, called CAR T cells, are then returned to your body to find and kill cancer cells.

Before you get ADCLEC.syn1, you will 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 must:

• Have AML that keeps growing or came back after treatment.
• Be eligible for a stem cell transplant. This may be needed if your bone marrow is not making blood cells quickly enough.
• 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 and to see if you can join this study, please call Dr. Jae Park’s office at 646-608-2091.