Due to their suppressive capacity, regulatory T cells (Tregs) have attracted growing interest as an adoptive cellular therapy for the prevention of allograft rejection, but limited Treg recovery and lower quality of adult-derived Tregs could represent an obstacle to success. To address this challenge, we developed a new approach that provides large quantities of Tregs with high purity and excellent features, sourced from thymic tissue routinely removed during pediatric cardiac surgeries (thyTregs). We report on a 2-year follow-up of the first patient treated worldwide with thyTregs, included in a phase I/II clinical trial evaluating the administration of autologous thyTreg in infants undergoing heart transplantation. In addition to observing no adverse effects that could be attributed to thyTreg administration, we report that the Treg frequency in the periphery was preserved during the 2-year follow-up period. These initial results are consistent with the trial objective, which is to confirm safety of the autologous thyTreg administration and its capacity to restore the Treg pool.
First-in-human therapy with Treg produced from thymic tissue (thyTreg) in a heart transplant infant
Disclosures: E. Bernaldo-de-Quirós reported a patent to WO2019/166658A1 pending. M. Pion reported a patent to WO2019/166658A1 issued. R. Correa-Rocha reported personal fees from THYTECH outside the submitted work; in addition, R. Correa-Rocha had a patent to WO2019/166658A1 pending. No other disclosures were reported.
- Award Id(s): FFA-2019
- Award Id(s): PI18/00495,PI18/00506,ICI20/00063,PI21/00189,CD18/00105
- Award Id(s): EXOHEP-CM,B2017/BMD-3727
- Award Id(s): MSCA-IF-EF-RI. 101028834
Esther Bernaldo-de-Quirós, Manuela Camino, Marta Martínez-Bonet, Juan Miguel Gil-Jaurena, Nuria Gil, Diana Hernández-Flórez, Maria Eugenia Fernández-Santos, Laura Butragueño, I. Esmé Dijke, Megan K. Levings, Lori J. West, Marjorie Pion, Rafael Correa-Rocha; First-in-human therapy with Treg produced from thymic tissue (thyTreg) in a heart transplant infant. J Exp Med 4 December 2023; 220 (12): e20231045. doi: https://doi.org/10.1084/jem.20231045
Download citation file: