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Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

2014-08-27 03:16:52 | BioPortfolio

Summary

This study is an investigational approach that uses immune cells, called "T cells", to kill leukemia. These T cells are removed from blood, modified in a laboratory, and then put back in the body. T cells fight infections and can also kill cancer cells in some cases. However, right now T cells are unable to kill the cancer cells. For this reason we will put a gene in the T cells that allows them to recognize and kill the leukemia cells. This gene will be put in the T cells by a weakened virus. The gene will produce a protein in the T cells that helps the T cells recognize the leukemia cells and possibly kill them. The doctors have found that T cells modified in this way can cure an ALL-like cancer in mice.

The main goal of this study is to find a safe dose of modified T cells to give to a patient with ALL. This will be done in a "phase I trial." The T cell dose will increase for each new group of patients as the trial progresses. If too many serious side effects are seen with a certain dose, no one will be treated with a higher dose, and some additional patients may be treated with a lower dose to make sure that this dose is safe. The patient will also receive the chemotherapy drug cyclophosphamide before the T cells. Cyclophosphamide is a chemotherapy normally used in patients with leukemia. Cyclophosphamide is given to reduce leukemia and to allow the T cells to live longer.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

gene-modified T cells targeted to B-ALL tumor cells

Location

Memorial Sloan Kettering Cancer Center
New York
New York
United States
10065

Status

Recruiting

Source

Memorial Sloan-Kettering Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:52-0400

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