eligibility_summary
Eligible: advanced/metastatic, unresectable solid tumor with KRAS G12V and HLA‑A11:01, ≥1 prior systemic therapy failed, measurable disease, ECOG 0–1, adequate organs. Exclude: recent anti‑tumor therapy, integrating gene therapy, allo/organ transplant, autoimmune or primary immunodeficiency, brain tumor or untreated CNS disease, active infection, pregnant/lactating, surgery/catheter procedures, allergy to LDC or product, uncontrolled illness, other malignancy <2 y, HBV/HCV/HIV+.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: AFNT-211, an autologous, gene-modified TCR-T cell therapy composed of engineered CD8+ and CD4+ T cells. Mechanism: T cells express an HLA-A11:01–restricted TCR specific for the KRAS G12V neoantigen (MHC-I) to recognize and kill tumor cells, include a wild-type CD8α/β coreceptor to strengthen TCR signaling, and a Fas–4-1BB switch receptor that converts Fas death signals into 4-1BB (CD137) costimulation, enhancing resistance to apoptosis and improving activation/persistence in the tumor microenvironment. Preconditioning: short lymphodepleting chemotherapy to promote engraftment. Targets: KRAS G12V–mutant tumor cells presenting peptide on HLA-A11:01, key pathways include TCR/MHC-I recognition, CD8 co-receptor signaling, Fas/FasL, and 4-1BB costimulation.