Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq

Tregzi is an allogeneic graft made by sorting a matched donor's mobilised blood into haematopoietic stem and progenitor cells and regulatory T cells, infusing them first, and giving a measured dose of conventional T cells two days later, so that the regulatory cells are in place before the effector cells arrive. In the phase 3 Precision-T trial, 187 adults with acute leukaemia or myelodysplastic syndrome undergoing myeloablative matched-donor transplantation were randomised to Tregzi with tacrolimus alone or a standard graft with tacrolimus and methotrexate; chronic graft-versus-host disease-free survival was not reached against 7.3 months (hazard ratio 0.26), and moderate to severe chronic graft-versus-host disease at one year fell from 44 percent to 13 percent, with every treated patient achieving neutrophil recovery within 28 days. The FDA approved it on 30 June 2026 for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival in adults with haematological malignancies having matched-donor transplantation with a myeloablative preparative regimen. The label warns of graft failure, graft-versus-host disease, infusion reactions and secondary malignancies. Whether the approach extends to mismatched and reduced-intensity transplants is being tested.