A Phase I Study of Genetically Modified T Cells to Treat Recurrent or Refractory Chronic Lymphocytic Leukemia

Protocol
06-138
Full Title
A Phase I/IIa Trial For The Treatment of Relapsed or Chemotherapy Refractory Chronic Lymphocytic Leukemia or Indolent B Cell Lymphoma Using Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19
Phase
I
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 returned 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 enables them to better recognize and kill leukemia cells. This gene allows the T cells to make a protein that helps them recognize leukemia cells and possibly kill them.

Researchers have already observed that T cells modified in this way were able to cure a cancer similar to CLL in mice. The main goal of this study is to find a safe dose of modified T cells to give to patients with advanced refractory or recurrent CLL.

Eligibility

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

  • Patients must have a confirmed diagnosis of advanced CLL that has persisted or returned despite prior treatment that included a purine analog drug (such as fludarabine or pentostatin)
  • Patients who have previously been treated with an allogeneic bone marrow transplant (i.e., from a donor) may not participate.

For more information and to see if you are eligible for this study, please contact Dr. Renier Brentjens at 212-639-7053.

Disease(s)
Leukemia
Leukemia: Chronic Lymphocytic Leukemia
Locations