A Phase IB/II Study of AUTO1 CAR T-Cell Therapy in People with Recurrent or Persistent B-Cell Acute Lymphoblastic Leukemia: The FELIX Trial

Full Title

An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a Car T Cell Treatment Targeting CD19, in Adult Patients with Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

Purpose

This study is evaluating the safety and effectiveness of a new form of CAR T-cell therapy for patients with B-cell acute lymphoblastic leukemia (ALL) that has continued to grow or came back after prior treatment. With CAR T-cell therapy, some of a patient’s own T cells (a type of white blood cell) are removed and genetically modified in a laboratory to recognize their own cancer cells. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancer cells throughout the body. This approach is a form of immunotherapy.

The CAR T-cell therapy being assessed in this study is called AUTO1. The modified T cells recognize a protein on cancer cells called CD19. There is another CAR T-cell therapy that targets CD19, but it is thought that AUTO1 will help shrink or stabilize cancer while causing fewer side effects than this other therapy.

Before patients receive AUTO1 CAR T cells, they will receive conditioning chemotherapy with fludarabine and cyclophosphamide to suppress the immune system and help prepare the body for receiving the CAR T cells. The treatments in this study are given intravenously (by vein).

Who Can Join

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

• Patients must have B-cell ALL that came back or continued to grow despite treatment.
• Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
• Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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. Jae Park at 646-608-3743.