
30 June 2026 - Today, the FDA approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell and T cells-vldq (Tregzi, Orca Bio) for use in matched donor hematopoietic stem cell transplantation with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival, in the treatment of adults with hematological malignancies.
Efficacy was evaluated in Precision-T, a multicenter, open-label, randomized, controlled trial in adults with acute leukemias or myelodysplastic syndrome.