ex-vivo expanded donor regulatory T cells

This is an investigational cell therapy consisting of ex-vivo expanded donor regulatory T cells (Tregs) developed by the H. Lee Moffitt Cancer Center and Research Institute for the prevention of graft-versus-host disease (GVHD). The active component consists of minor histocompatibility antigen (mHA)-specific donor CD4+CD25+Foxp3+ regulatory T cells. These cells are expanded ex vivo over a 12-day period under GMP conditions using a co-culture process with recipient dendritic cells, rapamycin, IL-2, and IL-15. The therapy is designed to suppress alloreactive donor T cells while preserving graft-versus-leukemia effects in patients undergoing hematopoietic cell transplantation (HCT). In Phase I clinical evaluation, the therapy demonstrated the ability of expanded Treg clones to persist and expand in vivo for up to one year post-transplant, showing potential in reducing the incidence of acute GVHD.

Other names

Cultured Treg cellsmHA-specific donor CD4+CD25+Foxp3+ regulatory T cellsallospecific regulatory T cells