Study of Allogeneic Gamma Delta T Cell Therapy for Patients With MRD-positive Acute Myeloid Leukemia After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the effectiveness and safety of allogeneic gamma delta T cells in adults with measurable residual disease MRD-positive acute myeloid leukemia AML after receiving an allogeneic hematopoietic stem cell transplantation allo-HSCT. This early-phase, single-center, randomized clinical trial aims to understand how well these specially prepared immune cells work in this specific patient group. Participants will receive infusions of ex-vivo expanded allogeneic T cells sourced from healthy donors. These cells are expanded and activated outside the body before being transfused into patients at doses of either 2 x 108 or 4 x 108 cells per kilogram. Patients will undergo at least four cycles of this T cell therapy, with treatments administered twice a week. During the study, participants will be monitored closely for treatment response, including objective response rate at four weeks and MRD-negative rates at two weeks. Researchers will also observe the duration of response, overall survival over two years, and safety throughout the study period. Assessments include regular clinical evaluations, laboratory tests, and safety observations to track the effects and any adverse events related to the therapy.

The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT