medcelerator · clinician one-pager
First FDA-Approved Cell Therapy to Reduce Chronic Graft-Versus-Host Disease
TREGZI (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) — donor cell transplant product to help adults with blood cancers stay free of chronic graft-versus-host disease
FDA Approved · United States · September 11, 2026
Condition: Chronic Graft-Versus-Host Disease
Who this is for
This is for adults with blood cancers who need a matched-donor stem cell transplant after intensive conditioning and who may be candidates for labelled US TREGZI instead of a conventional unmanipulated allograft. It explains the first FDA-approved Treg-based transplant product, the one-year chronic-GVHD-free survival numbers from Precision-T, infection and graft-failure watchpoints, Orca Bio contacts, and how to talk with a transplant team — without treating a phased centre launch as same-day care at every hospital, a DIY import as a plan, or “approved” as funded. Authorized is not funded.
Next clinical step
The US Food and Drug Administration (FDA) has approved this medicine. In the United States, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed.
Ways to access this treatment
United States · Prescription
US prescription (FDA-labelled)
https://www.fda.gov/vaccines-blood-biologics/tregzi
United States · Company expanded-access programme
Orca Bio expanded access NCT07346105 — out-of-specification commercial product only
https://clinicaltrials.gov/study/NCT07346105
United States · Recruiting clinical trial
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Combination or different setting. Orca-T after reduced-intensity conditioning; the label setting is myeloablative (phase 2).
https://clinicaltrials.gov/study/NCT07216443
United States · Recruiting clinical trial
Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT
Combination or different setting. Orca-T in advanced haematologic malignancies (phase 1).
https://clinicaltrials.gov/study/NCT06551584
See all 2 trials on ClinicalTrials.gov: https://clinicaltrials.gov/search?cond=hematologic%20malignancies&intr=Orca-T&aggFilters=status:rec
General resources for further research
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
AI-produced discussion aid; not prescribing instructions. Approval does not establish coverage. Full article: https://medcelerator.com/articles/tregzi-allogeneic-treg-hsct