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Unraveling Dynamics and Clinical Impact of Tregs in Allogeneic HSCT With PTCy

Sponsor: Ciceri Fabio

Summary

This prospective and retrospective, observational, monocentric study aims to investigate the longitudinal dynamics, phenotype, and functional properties of regulatory T cells (Tregs) in patients affected by hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PTCy)-based GvHD prophylaxis. Peripheral blood and bone marrow samples will be collected according to clinical practice at predefined timepoints and correlated with major transplant outcomes, including graft-versus-host disease (GvHD), relapse and graft-versus-tumor (GvT), infections, and inflammatory complications. The study hypothesis is that quantitative and functional alterations of Tregs after HSCT influence immune tolerance, GvHD occurrence, and graft-versus-tumor activity, and that the characterization of Treg dysfunction may support the development of innovative CAR-Treg-based immunotherapeutic strategies to control GvHD and preserve GvT. This is a prospective and retrospective, observational, biological, monocenter study. The retrospective component will consist of a cohort of patients with previously biobanked biological samples, collected between 2013 and September 2026, which will serve as a control group for the laboratory analyses.

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