allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (Stanford University)

**TRGFT-201** is the sponsor development code for **Orca-T**, now marketed in the United States as **Tregzi**. It is a personalized, donor-derived, high-precision allogeneic cell therapy composed of purified CD34-positive hematopoietic stem and progenitor cells, purified regulatory T cells, and conventional T cells obtained from an HLA-matched related or unrelated donor. The product is administered sequentially during matched-donor hematopoietic stem-cell transplantation after myeloablative conditioning; regulatory T cells are intended to establish immune tolerance and suppress pathogenic donor alloreactivity while conventional T cells preserve graft-versus-leukemia activity. On June 30, 2026, the FDA approved Tregzi for adult patients with hematological malignancies undergoing matched-donor transplantation with a myeloablative preparative regimen, to support hematopoietic and immunologic reconstitution and improve chronic graft-versus-host disease-free survival. ([fda.gov](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched))

Brand names

Tregzi

Other names

allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldqOrca-TTregGraft