Federal Grant Award Summary

St. Jude Children's Research Hospital Inc. received a $508,750 Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), effective February 13, 2026, with a completion date of January 31, 2028. The award supports research development of a method for engineering high-fidelity regulatory T cells (Tregs) as a therapeutic approach for immunological diseases including Type I diabetes and multiple sclerosis. The research employs innovative CRISPR/Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein 9) genome editing combined with bacteriophage integration systems to insert genes of interest into the 3' untranslated region of the endogenous FOXP3 (forkhead box P3) gene, thereby enhancing Treg lineage fidelity and regulatory function while avoiding integration site-related variability associated with conventional viral vector approaches.

The research addresses critical technical challenges in Treg engineering, including Treg plasticity under inflammatory conditions and contamination from activated conventional T cells that express FOXP3 transiently. By tethering the Treg master regulator FOXP3 to genes of interest, the methodology aims to generate stable, high-purity engineered Tregs with enhanced performance for both research and therapeutic applications. Preliminary studies have validated the approach in experimental mouse models, demonstrating proof-of-concept for this platform technology that may advance cell-based immunotherapies for autoimmune and inflammatory diseases.