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Treg-enriched donor cells (Dana-Farber) is an experimental cellular therapy developed by the Dana-Farber Cancer Institute for patients with relapsed/refractory or ultra-high-risk acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). This therapy is a central component of an "immunosuppression-free" (IS-free) haploidentical hematopoietic cell transplantation (HCT) protocol. The process involves the ex vivo enrichment of regulatory T cells (Tregs) from a haploidentical (half-matched) related donor. These Tregs are infused into the patient to suppress graft-versus-host disease (GvHD) by modulating the immune response, which allows for the co-infusion of unmodified donor T cells that provide a potent graft-versus-leukemia (GvL) effect. This approach aims to eliminate the need for post-transplant pharmacological immunosuppression. The protocol also includes conditioning with chemotherapy and targeted radiation, such as Total Myeloid and Lymphoid Irradiation (TMLI).
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