Background

This trial targets patients with relapsed or refractory acute myeloid leukemia (AML). Standard of care, which includes high-dose chemotherapy and hematopoietic stem cell transplantation (HSCT), is associated with high relapse risk and significant toxicity, creating an unmet need for novel immunotherapies.

Therapeutic Strategy

The study combines infusion of allogeneic NK cells mismatched for KIR-HLA (AdaptNK) with a short course of subcutaneous interleukin-2 (IL-2). NK cells are innate immune effectors that naturally lyse tumor cells, and AdaptNK cells exhibit enhanced activity following human cytomegalovirus (CMV) infection. IL-2 is a cytokine that supports NK cell proliferation and activation.

Clinical Design

This is a multicenter Phase 1/2 trial. Patients receive lymphodepleting chemotherapy with cyclophosphamide (CY) and fludarabine (FLU) followed by administration of NK cells and IL-2. Enrollment is ongoing; the study opened on May 8, 2026. The primary objectives are safety assessment and identification of early efficacy signals.

Expected Benefits

AdaptNK cells demonstrate superior long-term persistence and tumor-killing capacity compared with conventional NK cells, suggesting synergistic potential when combined before HSCT. If successful, the approach could expand pre-transplant therapeutic options for high-risk AML patients.

Market and Impact

Commercialization could secure a differentiated position in the cellular immunotherapy market. Moreover, bio-spin-offs originating from universities and research institutes may see increased investment attractiveness.