A Phase I Study of FT819 CAR T-Cell Therapy in People with B-Cell Cancers

Full Title

A Phase I Study of FT819 in Subjects with B-cell Malignancies

Purpose

The purpose of this study is to find the best way to give the investigational therapy FT819 safely in patients with B-cell lymphoma (BCL), chronic lymphocytic leukemia (CLL), or B-cell acute lymphocytic leukemia (B-ALL) that came back or continued to grow despite prior treatment.

FT819 is a cellular immunotherapy made in a laboratory starting with white blood cells (called T cells) that come from a healthy donor. The donated T cells are genetically modified to help them identify and kill cancer cells. A protein called chimeric antigen receptor (CAR) is added to the FT819 cells. CAR recognizes a protein called CD19 which is found on B-cell cancer cells. FT819 binds to B-cell cancer cells that contain CD19 and kills them. This CAR T-cell therapy is 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 BCL, CLL, or B-ALL that has come back or continued to grow despite prior treatment.
• Patients’ cancers must be positive for the CD19 protein.
• 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.