eligibility_summary
Adults 18–70 with advanced pancreatic or colorectal cancer after ≥2 lines, measurable disease, KRAS G12V/G12D + HLA-A11/C01:02/C08:02, ECOG ≤2, life ≥3 mo, adequate labs/organ, cardiac/ECG, consent, contraception. Exclude: other cancers, major cardiac/CNS/resp disease, active infections (HIV/HBV/HCV RNA+, syphilis), bleeding, autoimmune/immunosuppression, transplant, non‑central drains/catheters, recent G/GM-CSF, gene/cell therapy, or trials, contraindications, breastfeeding, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: IX001 TCR-T cells (autologous, gene-engineered T-cell receptor T cells) infused IV after lymphodepletion, followed by recombinant human IL-2 (cytokine) to support expansion/persistence. Mechanism: Patient T cells are modified to express a TCR that specifically recognizes KRAS G12V or G12D neoantigen peptides presented on HLA-A11, C01:02, or C08:02, enabling MHC-restricted tumor recognition and cytotoxic killing. Targets: KRAS-mutant pancreatic and colorectal cancer cells, focuses on tumors driven by mutant KRAS (RAS/MAPK pathway). Engages HLA class I antigen presentation and activates cytotoxic T-lymphocyte immune pathways. Phase: Single-arm, 3+3 dose-escalation (Phase 1).