eligibility_summary
Eligible: adults 18–75 with unresectable/advanced solid tumors lacking standard options, HLA‑A11:01+, KRAS G12V (NW‑301V) or G12D (NW‑301D), adequate organ function, ECOG 0–1, ≥1 RECIST 1.1–measurable lesion. Exclude: recent chemo/biologics/immunosuppressants (≤2w pre‑apheresis/≤1w pre‑lymphodepletion), allergy to cyclophosphamide/fludarabine, severe autoimmune disease, symptomatic CNS/leptomeningeal mets, active infections incl HIV/HBV/HCV/syphilis, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, open-label dose-escalation trial of two autologous, gene-engineered T-cell therapies: NW-301V (TCR-T targeting KRAS G12V) and NW-301D (TCR-T targeting KRAS G12D). Mechanism: patient T cells are modified to express an HLA-A11:01–restricted T-cell receptor that recognizes mutant KRAS peptides on tumor cells, driving antigen-specific cytotoxicity. Patients receive cyclophosphamide/fludarabine lymphodepletion and low-dose IL-2 to aid engraftment/expansion. Targets: tumor cells with KRAS G12V or G12D, pathways: mutant KRAS within the RAS/MAPK axis and TCR-mediated immune killing.