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CD4-positive donor lymphocytes is an investigational cellular immunotherapy being developed by Leiden University Medical Center (LUMC). The therapy consists of purified CD4-positive (helper) T-lymphocytes derived from an allogeneic donor. It is administered as a prophylactic infusion approximately three months after T-cell depleted allogeneic stem cell transplantation in patients with leukemia. The mechanism of action involves donor CD4+ T-cells recognizing minor histocompatibility antigens (MiHA) presented on HLA class II molecules, which are primarily expressed on hematopoietic and malignant cells. This recognition triggers a graft-versus-leukemia (GvL) effect, aiming to prevent disease relapse while minimizing the risk of graft-versus-host disease (GVHD).
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