A Phase I Study of "Armored" Genetically Modified T Cells to Treat Patients with Recurrent or Persistent Chronic Lymphocytic Leukemia

Full Title

A Phase I Trial of CD19-Targeted EGFRt/19-28z/4-1BBL “Armored” Chimeric Antigen Receptor (CAR) Modified T Cells in Patients with Relapsed or Refractory CD19+ Hematologic Malignancies

Purpose

The purpose of this study is to evaluate a new treatment for patients with advanced chronic lymphocytic leukemia (CLL) that has not responded to treatment or has come back after treatment. The treatment involves an investigational therapy which uses a patient’s own immune cells, called “T cells,” to kill tumor cells. These T cells are removed from the blood, modified in the laboratory, and then returned to the patient’s body.

T cells help the body fight infections. These cells can also kill cancer cells in some cases. In patients with advanced CLL, however, the T cells are unable to kill the cancer cells. For this reason, investigators will modify each patient’s T cells by inserting a gene into them that allows them to make a protein that helps the T cells to better recognize leukemia cells and possibly kill them.

To improve the effectiveness of this treatment, the modified T cells will also include a gene to help them express a protein called 4-1BBL. This protein may help further activate the modified T cells and enable them to survive longer in the body. Laboratory studies suggest this approach could possibly help patients achieve remission more quickly and survive longer than patients who were treated in earlier studies with a previous version of the modified T cells.

Eligibility

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

  • Patients must have CLL that has stopped responding to therapy or came back after prior treatment and is positive for the CD19 protein (the target of the genetically modified T cells).
  • 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 212-639-4048.

Protocol

16-1570

Phase

I

Investigator