Full TitleA 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 Back to top
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.Back to top
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.