A Phase I/IIa Study of TGFß Blockade in TCR-Engineered T-Cell Cancer Immunotherapy in Patients with Advanced Malignancies
This phase I/IIa trial studies the side effects and best dose of a gene-modified T cells and to see how effective it is in treating patients with solid tumors expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread from where it started to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (metastatic). A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Placing a modified gene for NY-ESO-1 into the patients' T cells in the laboratory and then given them back to the patient may help the body build an immune response to kill tumor cells that express NY-ESO-1. Drugs used in chemotherapy, such as cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading, and it may also allow genetically modified T cells to grow.