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Universal Donor CD33 CAR Natural Killer Cells for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Trial Status: approved

This phase I/II trial tests the safety, side effects and best dose of universal donor CD33 chimeric antigen receptor (CAR)-natural killer (NK) cells in combination with fludarabine, cytarabine and venetoclax and how well the combination works in treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR therapy is a type of treatment in which a patient's T cells or B cells (immune cells) are changed in the laboratory so they will attack cancer cells. NK cells are immune cells that can recognize and kill cancer cells. CD33 CAR-NK cells are genetically changed to have a CAR that recognizes and binds to the protein, CD33, on cancer cells and signals the NK cell to attack. Fludarabine blocks cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of purine antagonist and a type of ribonucleotide reductase inhibitor. Cytarabine blocks cancer growth by stopping DNA synthesis. It is a type of antimetabolite. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving universal donor CD33 CAR-NK cells in combination with fludarabine, cytarabine and venetoclax may be safe, tolerable and/or effective in treating patients with relapsed or refractory acute myeloid leukemia.