AFNT-212

AFNT-212 is a gene-edited, KRAS G12D-targeting TCR-T cell therapy developed for the treatment of solid tumors harboring the KRAS G12D mutation. This next-generation engineered T cell product uses non-viral targeted knock-in at the TCRα constant (TRAC) locus to express a high-avidity, HLA-A*11:01-restricted, KRAS G12D-specific T cell receptor (TCR), and is further enhanced with CD8αβ and a chimeric cytokine receptor to improve anti-tumor potency and resistance to exhaustion. Preclinical studies have demonstrated that AFNT-212-engineered T cells exhibit strong cytotoxicity against multiple KRAS G12D-positive tumor cell lines—including colon, pancreas, lung, and cholangiocarcinoma—and mediate robust anti-tumor activity in vivo with low risk of off-target toxicity. The therapy leverages Affini-T’s proprietary non-viral knock-in THRIVE platform for efficient transgene integration and expansion of engineered cells suitable for clinical application. Clinical investigation is planned for 2024[1][3][5][6][8].