allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq + tacrolimus + ruxolitinib

**Orca-T + tacrolimus + ruxolitinib** is an investigational combination regimen being evaluated for graft-versus-host disease (GVHD) prophylaxis in patients with advanced hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT) from HLA-mismatched (7/8) donors. The regimen combines **Orca-T** (Tregzi), a precision-engineered, donor-derived allogeneic cell therapy developed by Orca Bio, with dual-agent immunosuppressive prophylaxis consisting of **tacrolimus** and **ruxolitinib**. Orca-T is composed of highly purified donor hematopoietic stem and progenitor cells (HSPCs) and regulatory T cells (Tregs) infused on Day 0, followed by conventional T cells (Tcons) on Day +2 or +3. The Tregs suppress alloreactivity to prevent GVHD, while Tcons accelerate immune reconstitution and maintain the graft-versus-tumor effect. Tacrolimus, a small-molecule calcineurin inhibitor, and ruxolitinib, a small-molecule JAK1/2 inhibitor, are sequentially administered post-transplant to provide synergistic GVHD prophylaxis. This combination is currently being evaluated in the Phase 1 ACCESS-T trial (NCT06551584) led by Stanford University.

Other names

TRGFT-201 + tacrolimus + ruxolitiniballogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq + tacrolimus + ruxolitinibOrca-T + (tacrolimus and ruxolitinib)Orca-T + tacrolimus + ruxolitinibTregzi + tacrolimus + ruxolitinib