Phase I Study of Expanded Gamma Delta T-cell Infusion After Haploidentical Stem Cell Transplant for Leukemia and Myelodysplastic Syndromes

What this Trial Is About

Researchers are studying gamma delta T-cells, a part of the immune system that can identify and kill cancer cells, to improve treatment for patients with leukemias and myelodysplastic syndromes who have had a partially matched bone marrow transplant haploidentical. The study aims to enhance the anti-tumor response while reducing the risk of graft versus host disease GVHD, a serious complication after such transplants. The treatment involves collecting peripheral blood from donors, expanding and activating gamma delta T-cells using specialized devices, and removing most alpha beta T-cells to produce a gamma delta T-cell rich product. This product is then infused into recipients at different cell concentrations depending on the study phase, including a phase to determine the maximum tolerated dose. Participants will undergo regular monitoring including tests for toxicity, adverse events, and the rate of GVHD from baseline up to 100 days. Researchers will also track relapse rates, survival, and chronic GVHD up to one year. Organ function, infection status, and other health assessments will be performed before and after infusion to ensure safety throughout the study period, which started in 2020 and continues through 2028.

Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide