Drug intelligence / Profile preview

allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (Orca Bio)

Development stage
Phase 2
Lead developer
Stanford University
Modality
Stem Cell Therapies → Cell Therapies
Administration
Intravenous
01

Overview

**Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq** is a donor-derived, precision-engineered allogeneic cellular therapy developed by Orca Bio and clinically known as Orca-T. It is manufactured from mobilized peripheral-blood apheresis material from an 8/8 HLA-matched related or unrelated donor and contains defined populations of highly purified regulatory T cells, hematopoietic stem and progenitor cells, and conventional T cells. The regulatory T-cell component is intended to establish immune tolerance and suppress pathogenic alloreactivity, reducing graft-versus-host disease while preserving conventional T-cell-mediated graft-versus-leukemia activity and hematopoietic reconstitution. It was approved in the United States as Tregzi for use with matched-donor hematopoietic stem-cell transplantation and myeloablative preparative conditioning in adults with hematologic malignancies to support hematopoietic and immunologic reconstitution and improve chronic graft-versus-host disease-free survival.

Brand names
Tregzi
Other names
Orca-T
02

Targets

CD19 (B lymphocyte antigen CD19)CD22 (Cluster of Differentiation 22)

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