eligibility_summary
Inclusion: 18–75, unresectable advanced cancer after systemic therapy failure/intolerance, measurable disease, HLA‑A11:01+ and KRAS G12V+, ECOG 0–1, survival ≥3 mo, adequate labs/organ function, no recent systemic therapy. Exclusion: pregnancy, active HIV/HCV/TB/HBV or serious infection, unresolved ≥G2 AEs, allergy to study/preconditioning meds, transplant, recent major surgery/trauma, serious cardio‑pulmo‑metabolic disease, immunosuppression, CNS mets, substance abuse, other cancer ≤2 yrs, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I single-arm trial in advanced solid tumors with KRAS G12V and HLA-A11:01. Intervention: YK0901, an autologous, genetically engineered TCR-T cell therapy. Patient T cells are transduced with a TCR that recognizes the KRAS G12V neoepitope presented by HLA‑A11:01, enabling MHC class I–restricted cytotoxic killing of KRAS G12V–mutant tumor cells. Conditioning drugs: fludarabine (purine antimetabolite) and cyclophosphamide (alkylating agent) for lymphodepletion, plus oxaliplatin (platinum DNA crosslinker) potentially enhancing immunogenic tumor cell death. Supportive cytokine: low-dose recombinant IL‑2 to promote T‑cell survival/expansion. Cells/pathways targeted: KRAS G12V–mutant tumor cells, TCR–peptide–HLA signaling, CD8+ cytotoxic T-cell activation, and lymphocyte homeostasis via lymphodepletion.