A Phase I Study of Consolidation Therapy with Autologous T Cells Genetically Targeted to CD19 in Patients with Chronic Lymphocytic Leukemia After Initial Chemotherapy

Protocol
11-048
Full Title
A Phase I Trial of Consolidation Therapy with Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 in Patients with Chronic Lymphocytic Leukemia Following Upfront Chemotherapy with Pentostatin, Cyclophosphamide and Rituximab
Phase
I
Purpose

This study is evaluating a new gene therapy for patients with chronic lymphocytic leukemia (CLL) that persists despite standard chemotherapy. The therapy uses white blood cells called T cells that have been modified to recognize and kill leukemia cells by targeting a protein on CLL cells called CD19.

The modification is achieved by taking T cells from a patient’s blood and inserting a gene into them. The goal of this study is to find the optimal dose of these modified T cells that can be given to patients with CLL that persists despite initial chemotherapy.

T cells that were modified in this way were shown to cure a cancer similar to CLL in mice. Early studies in patients who received the therapy showed tumor shrinkage or a slowing of tumor growth in some patients.

Eligibility

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

  • Patients must have CLL that persists despite prior treatment with pentostatin, cyclophosphamide, and rituximab.
  • Patients may not have previously been treated by allogeneic or stem cell transplantation.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 212-639-4048.

Disease(s)
Leukemia
Leukemia: Chronic Lymphocytic Leukemia
Locations