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

**Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq** is an FDA-approved, donor-derived, precision-engineered allogeneic cell therapy developed by Orca Bio and previously known clinically as **Orca-T**. Marketed as **Tregzi**, it is manufactured from mobilized peripheral blood of a matched related or unrelated donor and contains purified hematopoietic stem and progenitor cells, regulatory T cells, and conventional T cells administered sequentially. The regulatory T-cell component is intended to establish immune tolerance and suppress alloreactive donor immune responses, thereby reducing graft-versus-host disease while preserving donor immune reconstitution and graft-versus-leukemia activity. It is indicated in the United States for adults with hematological malignancies undergoing matched-donor hematopoietic stem cell 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

Orca-Tallogeneic regulatory T-cell immunotherapy with hematopoietic stem and progenitor cells and T cells-vldq