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CD4+CD25+ regulatory T cells (Masonic Cancer Center) is an investigational adoptive cellular immunotherapy developed by the Masonic Cancer Center at the University of Minnesota for the prevention of graft-versus-host disease (GVHD). The therapy consists of donor-derived regulatory T cells (Tregs) that are isolated from HLA-identical sibling donors and expanded ex vivo using anti-CD3/anti-CD28 antibody-coated beads. These expanded Tregs, which express the FoxP3 transcription factor, are infused into patients undergoing allogeneic hematopoietic stem cell transplantation for high-risk hematologic malignancies. The primary mechanism of action involves the suppression of alloreactive donor T cell responses against recipient tissues, thereby reducing the incidence and severity of GVHD while potentially preserving the beneficial graft-versus-leukemia effect. Clinical development reached Phase I/II but the primary study was terminated due to slow patient accrual.
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