GNTI-122 + rapamycin

GNTI-122 + rapamycin is an investigational, autologous, dual-engineered regulatory T cell (EngTreg) therapy specifically developed for the treatment of recently diagnosed Type 1 Diabetes. GNTI-122 is manufactured from a patient's own CD4+ T cells, which are engineered to stably express FOXP3 (to ensure a regulatory phenotype), an engineered TCR specific for the islet antigen IGRP_305–324 (presented by HLA-DRB1*04:01), and a chemically inducible signaling complex (CISC) providing rapamycin-dependent interleukin-2 (IL-2)–like survival and proliferation signaling. This design allows GNTI-122 cells to home to the pancreas, become activated upon antigen encounter, and exert potent immunosuppressive effects via direct suppression and bystander suppression of pathogenic effector T cells. Rapamycin co-administration (target trough 3–6 ng/mL) is required to support GNTI-122 persistence and function post-infusion, both in vivo and during manufacturing, leveraging the CISC feature. GNTI-122 + rapamycin is studied as a next-generation, targeted immunotherapy seeking to restore immune tolerance, preserve β cell function, and halt progression of Type 1 Diabetes in HLA-DRB1*04:01+ adults.