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

Source: https://onco.cc/drugs/tregzi/  
OnCo record `tregzi` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Tregzi, formerly Orca-T, is a donor stem cell transplant sorted with high precision and given with regulatory T cells, so that patients with blood cancers keep the graft's anti-cancer effect while being protected from chronic graft-versus-host disease. The FDA approved it on 30 June 2026 for adults having a matched-donor transplant.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-17
- Also known as: Orca-T; Tregzi
- Brand: Tregzi
- Code: Orca-T
- Modality: Precision-sorted allogeneic stem cell graft with regulatory T cells
- Mechanism: High-precision cell sorting separates the donor graft into stem and progenitor cells, regulatory T cells and conventional T cells; regulatory T cells infused ahead of a controlled conventional T cell dose suppress alloreactivity while preserving graft-versus-leukaemia and immune reconstitution.
- Approvals: US 2026: Adults with haematological malignancies undergoing matched-donor haematopoietic stem cell transplantation with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival

## Sources

- FDA approval notice (30 June 2026): https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched
- ClinicalTrials.gov NCT05316701 (Precision-T): https://clinicaltrials.gov/study/NCT05316701

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Myelodysplastic syndromes / neoplasms (MDS)](https://onco.cc/cancers/mds/)
- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/)
- technologies: [Allogeneic (off-the-shelf) cell therapy](https://onco.cc/technologies/allogeneic-cell-therapy/), [Allogeneic stem cell transplantation](https://onco.cc/technologies/allogeneic-hsct/)
- companies: [Orca Bio](https://onco.cc/companies/orca-bio/)
- trials: [Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies](https://onco.cc/trials/nct05316701/)

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