Phase 1 Study of Cytokine Induced Memory-Like Natural Killer Cells with Atezolizumab for Adults with Relapsed or Refractory Acute Myelogenous Leukemia

What this Trial Is About

Researchers are evaluating the highest dose of cytokine-induced memory-like CIML natural killer NK cells combined with the drug atezolizumab in people with relapsed or refractory acute myelogenous leukemia AML. This Phase 1 study aims to find a dose that causes only mild or few side effects while assessing the treatments effects on participants cancer. The trial is sponsored by Memorial Sloan Kettering Cancer Center and focuses on treatment for AML patients who have limited options due to resistance or relapse. Participants receive pre-conditioning chemotherapy with fludarabine and cyclophosphamide before infusion of the CIML-NK cells intravenously. On the day of infusion, they get a single intravenous dose of atezolizumab over 60 minutes followed by subcutaneous injections of recombinant human IL-2 every other day for six doses starting the same day. The study is a single-group design, and all participants receive this combination treatment. During the study, participants are monitored for side effects and treatment response over a period of up to two years. Assessments include safety evaluations to determine the maximum tolerated dose and measuring the response rate of complete remission or complete remission with incomplete blood count recovery. Participants undergo regular clinical evaluations, laboratory tests, and supportive care according to guidelines. The study completion is expected by May 2028.

A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia