Study protocol: Phase I/II trial of induced HLA-G⁺ regulatory T cells in patients undergoing allogeneic hematopoietic cell transplantation from an HLA-matched sibling donor.

ABSTRACT: Regulatory T-cell (Treg) immunotherapy has emerged as a promising and highly effective strategy to combat graft-versus-host disease (GvHD) after allogeneic hematopoietic cell transplantation (allo-HCT). Both naturally occurring Treg and induced Treg populations have been successfully evaluated in trials illustrating the feasibility, safety, and efficacy required for clinical translation. Using a non-mobilized leukapheresis, we have developed a good manufacturing practice (GMP)-compatible induced Treg product, termed iG-Tregs, that is enriched in cells expressing the potent immunosuppressive human leucocyte antigen-G molecule (HLA-G⁺). To assess the safety and the maximum tolerable dose (MTD) of iG-Tregs, we conduct a phase I-II, two-center, interventional, dose escalation (3 + 3

SUBMITTER: Lysandrou M 

PROVIDER: S-EPMC10237041 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature