Phase 3 Evaluation of TSC-101, a Donor-Derived Engineered T-Cell Therapy, in Adults with AML or MDS Undergoing Reduced-Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of TSC-101, a genetically engineered donor T-cell therapy, in adults with acute myeloid leukemia AML or myelodysplastic syndromes MDS undergoing allogeneic peripheral blood stem cell transplantation with reduced-intensity conditioning RIC. This Phase 3, multicenter, genetically-randomized controlled study compares TSC-101 plus standard of care SOC to SOC alone in patients receiving stem cells from haploidentical or mismatched unrelated donors. Participants in the treatment group who are HLA-A*0201 positive and HA-2 positive will receive two infusions of TSC-101 after transplantation the first about 21 days post-transplant and the second 40 to 68 days later. All participants will receive SOC transplantation procedures including RIC regimens, peripheral blood stem cell transplantation, and post-transplant cyclophosphamide for graft-versus-host disease prevention. Those not eligible for the treatment arm or lacking an appropriate donor will receive SOC alone. Participants will be followed for up to 3 years after transplantation to monitor relapse-free survival and other health outcomes, including quality of life measured by several standardized tools. Safety is closely monitored through adverse event reviews, lab tests, and clinical exams with oversight by an independent Data Safety Monitoring Board. Those receiving TSC-101 infusion will also be invited to join a long-term follow-up study lasting up to 15 years to assess long-term safety and survival.

A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation