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PRAME-TCR-NK Cells with Lymphodepleting Chemotherapy for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome/Chronic Myelomonocytic Leukemia

Trial Status: active

This phase I/II trial tests the safety, side effects, best dose and effectiveness of PRAME-T cell receptor-natural killer (PRAME-TCR-NK) cells with lymphodepleting chemotherapy in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)/chronic myelomonocytic leukemia (CMML) that has come back after a period of improvement (relapsed) or that has not responded to treatment (refractory). T cells and NK cells are infection fighting blood cells that can kill tumor cells. The T cells and NK cells given in this study are modified to recognize PRAME, a protein on the surface of cancer cells. These PRAME-specific cells may help the body's immune system identify and kill cancer cells that express PRAME. Chemotherapy drugs, such as decitabine, fludarabine, and cyclophosphamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PRAME-TCR-NK cells with lymphodepleting chemotherapy may be safe, tolerable, and/or effective in treating patients with relapsed and refractory AML or MDS/CMML.