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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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Medical and Biotech [MESH] Definitions

The introduction of new genes into cells for the purpose of treating disease by restoring or adding gene expression. Techniques include insertion of retroviral vectors, transfection, homologous recombination, and injection of new genes into the nuclei of single cell embryos. The entire gene therapy process may consist of multiple steps. The new genes may be introduced into proliferating cells in vivo (e.g., bone marrow) or in vitro (e.g., fibroblast cultures) and the modified cells transferred to the site where the gene expression is required. Gene therapy may be particularly useful for treating enzyme deficiency diseases, hemoglobinopathies, and leukemias and may also prove useful in restoring drug sensitivity, particularly for leukemia.

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