eligibility_summary
Adults 18-75 with advanced solid tumors, failed/untolerated standard therapy, ≥1 measurable lesion, HLA-A11:01+ and KRAS G12V, ECOG 0-1, LVEF ≥50%, adequate labs, contraception, and able to comply. Exclude recent anticancer therapy, prior KRAS G12V–targeted or gene/cell therapy, unresolved toxicity, allergy to study drugs, major CVD/QTc≥450 ms, active TB/HIV/HBV/HCV, autoimmune disease, immunosuppressants, symptomatic brain mets/leptomeningeal disease, bleeding/clots, large effusions, recent live vaccine, transplants, uncontrolled DM/lung/liver disease, substance abuse, pregnancy, or incapacity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, single-arm trial of RE001: an autologous, gene-edited TCR-engineered T-cell (TCR-T) therapy that recognizes the KRAS G12V neoantigen presented by HLA-A11:01 to kill tumor cells. Mechanism: infused T cells bind KRAS G12V peptide–HLA on cancer cells and mediate cytotoxicity, lymphodepleting cyclophosphamide (alkylating agent) and fludarabine (purine analog) are given to improve engraftment. Targets: tumor cells harboring KRAS G12V across solid tumors, KRAS-driven signaling (MAPK/PI3K) pathway, preconditioning transiently reduces host lymphocytes/Tregs. Dose escalation: 4×10^9–1.6×10^10 cells.