Study of AdaptNK Natural Killer Cell Therapy with Chemotherapy and IL-2 for Adults with High-Risk Acute Myeloid Leukemia as a Bridge to Stem Cell Transplant

What this Trial Is About

Researchers are studying an advanced immunotherapy approach using an allogeneic natural killer NK cell product called AdaptNK for patients with relapsed or refractory acute myelogenous leukemia AML. This Phase III trial evaluates the safety and effects of AdaptNK cells, which have a special adaptive phenotype influenced by cytomegalovirus CMV, combined with a short course of interleukin-2 IL-2 after chemotherapy that reduces lymphocytes. The study targets high-risk myeloid diseases and aims to support patients as a bridge to allogeneic stem cell transplantation. Participants receive different dose levels of AdaptNK cells intravenously, ranging from less than 1 x 108 up to 3 x 109 total nucleated cells. Before this infusion, patients undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine to prepare the body. After the NK cell infusion, IL-2 is given subcutaneously every other day for three doses to support the NK cells. The study includes multiple dose cohorts to assess safety and determine the maximum tolerated dose. During the trial, participants are closely monitored with regular assessments to measure safety and response to treatment, including checking the maximum tolerated dose over one year and objective response by day 42. The research team tracks any side effects, evaluates how well the therapy is tolerated, and follows participants for safety outcomes. The total duration and detailed scheduling of visits are based on the treatment phases and follow-up assessments outlined in the protocol.

Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT