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This experimental cell therapy approach, developed by the Dana-Farber Cancer Institute, is designed for patients with relapsed/refractory or ultra-high-risk acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The therapy is part of an immunosuppression-free (IS-free) haploidentical hematopoietic cell transplantation (HCT) protocol. It involves the infusion of donor-derived regulatory T cells (Tregs) that have been enriched to suppress graft-versus-host disease (GVHD). This is followed by the infusion of unmodified donor T cells, which provide a graft-versus-leukemia (GVL) effect, and CD34+ peripheral blood stem cells to rescue hematopoiesis. By using Tregs to control alloreactivity, the protocol aims to eliminate the need for traditional post-transplant immunosuppressive medications while maximizing the anti-tumor activity of the donor's immune system.
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