eligibility_summary
Eligible: age >=18 with metastatic solid tumor, HLA-A11:01, KRAS G12V, measurable disease, prior indicated therapies, ECOG 0-1, adequate organ function (CrCl >=50, Tbili <2, AST/ALT <5xULN, ANC >=1000, albumin >=3), willing for biopsies, treatment washout, contraception. Exclude: prior solid-organ (except select kidney) or allo-HSCT, pregnancy/breastfeeding, active autoimmune on immunosuppression, >0.5 mg/kg steroids, other trials, uncontrolled infection/illness, untreated brain mets, uncontrolled effusions, drug allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, single-arm adoptive cell therapy testing FH-A11KRASG12V-TCR (AFNT-111): autologous CD8+ and CD4+ T cells genetically engineered to express a high-affinity TCR specific for the KRAS G12V peptide presented by HLA-A11:01. Mechanism: TCR recognition of KRAS G12V–HLA activates cytotoxic and helper T-cell responses to kill tumor cells, optional repeat infusion. Lymphodepletion uses cyclophosphamide + fludarabine or bendamustine (types: alkylating agents, fludarabine is a purine analog) to deplete host lymphocytes and enhance T-cell engraftment/expansion. Targets: metastatic solid tumors with KRAS G12V, HLA-A11:01–restricted, antigen-positive tumor cells. Pathways: mutant KRAS-driven RAS/MAPK, TCR-mediated cytotoxic immune activation.