eligibility_summary
Eligibility: Adults 18–75 with unresectable/advanced solid tumor lacking standard options, HLA-A11:01+, KRAS G12V (NW-301V) or G12D (NW-301D), adequate organ function, ECOG 0–1, measurable disease (RECIST 1.1). Exclude: recent chemo/biologics/immunosuppressants near apheresis/lymphodepletion, allergy to cyclophosphamide/fludarabine, significant/active autoimmune in past year, symptomatic CNS/leptomeningeal disease, active infections (HIV/HBV/HCV/syphilis), pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, open-label, dose-escalation trial of two TCR-T cell therapies: NW-301V (targets KRAS G12V) and NW-301D (targets KRAS G12D). Type of drug: autologous, genetically engineered T cells expressing an HLA-A11:01–restricted T cell receptor specific for mutant KRAS neoantigens. Mechanism of action: following lymphodepletion (cyclophosphamide + fludarabine) and a single IV infusion, engineered T cells recognize KRAS G12V or G12D peptides presented on tumor HLA-A11:01, activate, expand (supported by low-dose IL-2), and mediate cytotoxic killing of tumor cells. Cells/pathways targeted: tumor cells harboring KRAS G12V or G12D in advanced solid tumors, antigen presentation via HLA class I, downstream oncogenic KRAS/RAS–MAPK–PI3K signaling dependencies indirectly targeted through selective elimination of mutant KRAS–expressing cells.