Drug intelligence / Profile preview

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

Development stage: Approved
Lead developer: Orca Biosystems
Modality: CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, TCR-Engineered T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Tumor-Infiltrating Lymphocytes (TILs) → Native Immune Cells → Adoptive Cell Transfer → Cell Therapies, Stem Cell Therapies → Cell Therapies
Administration: Intravenous

Overview

**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

Beyond the preview

Go deeper on allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (Stanford University).

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Follow clinical development from study design and recruitment through results.

Trial phase
Status
Readouts

Indications & development

Explore development by indication, patient population, and geography.

Indications
Development status
Countries

Licensing & deals

Trace asset ownership, licensing agreements, and commercial partnerships.

Partners
Deal terms
Milestones

Patents & exclusivity

Explore the patent landscape and regulatory exclusivity around an asset.

Patents
Expiration dates
Exclusivity

Competitive landscape

Compare development programs by target, modality, and indication.

Competing assets
Targets
Development stage

Research & analysis

Connect source evidence and development news to your research questions.

Publications
News
Analysis

Bring the full picture into focus.

See how Gosset can support your research on allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (Stanford University).