Phase 1 Study Testing Cytokine-Induced Memory-like CIML NK Cells Combined With Venetoclax as Treatment for Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and potential effectiveness of combining cytokine-induced memory-like CIML natural killer NK cells with Interleukin-2 IL-2 and the standard treatment venetoclax for people with Acute Myeloid Leukemia AML. This phase I study is the first to give CIML NK cells with venetoclax in humans and aims to establish the maximum tolerated dose while monitoring side effects. The study is sponsored by the Dana-Farber Cancer Institute and funded by the Leukemia and Lymphoma Society. Participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide before the CIML NK cell infusion. The CIML NK cells are given intravenously on Day 0, followed by IL-2 injections every other day for up to five doses and daily oral venetoclax from Day 7 through Day 20. Hospitalization for 3 to 4 weeks is expected during the CIML NK infusion. Dose adjustments may occur based on observed side effects, and follow-up visits will take place at Days 42, 60, 100, and Months 6, 9, and 12. Participants will undergo screening, including bone marrow biopsies, blood tests, electrocardiograms, and echocardiograms. Researchers will monitor side effects, leukemia status, and survival outcomes over one year. Measures such as dose-limiting toxicity, maximum tolerated dose, measurable residual disease, leukemia-free survival, overall survival, and rates of graft-versus-host disease will be assessed. Participants are expected to be involved in multiple visits during treatment and follow-up to track safety and treatment response.

CIML NK Cells With Venetoclax for AML