A Phase I Trial of B-Cell Acute Lymphoblastic Leukemia Treated with Autologous T Cells Gene-Targeted to the B-Cell Antigen CD19

Protocol
09-114
Full Title
A Phase I Trial of Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated with Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19(CAR)
Phase
I
Disease Status
Relapsed/Refractory
Purpose

This study is evaluating an investigational approach that uses immune cells called T cells to kill B-cell acute lymphoblastic leukemia (ALL) that has returned, stopped responding to therapy, or is in first remission and at risk of returning. The T cells are removed from the patient’s blood, modified in a laboratory, and then returned to the patient’s body.

Investigators put a gene in the patient’s T cells that allows them to recognize and kill leukemia cells. The gene will produce a protein in T cells that helps them recognize leukemia cells and possibly kill them. Researchers have found that T cells modified in this way can cure an ALL-like cancer in laboratory studies.

Eligibility

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 has returned, stopped responding to therapy, or is in first complete remission and at risk of returning.
  • Patients’ ALL must be positive for the CD19 antigen.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Renier Brentjens at 212-639-7053.

Disease(s)
Leukemia
Leukemia: Acute Lymphoblastic Leukemia
Locations
Related Diseases