A Phase I Study of Genetically Modified T Cells Targeting CD19 in Pediatric and Young Adult Patients with Relapsed B-Cell Acute Lymphoblastic Leukemia

Full Title

A Phase I Trial of Autologous T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients with relapsed B-Cell Acute Lymphoblastic Leukemia

Purpose

Patients with B-cell acute lymphoblastic leukemia (B-ALL) that has returned after initial treatment have a limited number of treatment options. The goal of this study is to assess the safety of a new therapy that can be given to pediatric and young adult patients with B-ALL that has returned despite prior therapy.

The investigational therapy uses T cells (a type of white blood cell) that have been removed from the patient and genetically modified in the laboratory to recognize a protein on leukemia cells called CD19. The modified T cells are returned to the patient, and it is hoped that they will find and kill leukemia cells. T cells altered in this way were shown to be capable of killing B-cell cancers in laboratory studies and in adults with B-cell ALL that has returned after chemotherapy.

Eligibility

  • Patients must have CD19-positive B-ALL that has returned or persisted despite prior therapy.
  • Patients who have had a stem cell transplant may not participate.
  • This study is open to patients under age 26. (Patients over the age of 26 should contact Dr. Marco Davilia at 212-639-4056 for information on this treatment option.)

For more information and to inquire about eligibility for this study, please contact Dr. Kevin J. Curran at 212-639-5836.

Protocol

13-052

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Locations