eligibility_summary
Eligible: patients with advanced cancer, life expectancy >12 weeks, adequate heart/lung/liver/kidney/blood function, vaccine available, and able to provide informed consent. Exclude: prior gene therapy, severe or active infections (HBV, HCV, HIV, bacterial, fungal), significant comorbidities, pregnancy or breastfeeding, systemic steroids ≥0.5 mg/kg/day, or other investigator-determined risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06195384 tests a personalized anti-cancer neoantigen mRNA vaccine for advanced solid tumors. Intervention: Biological—patient-specific mRNA vaccine encoding tumor neoantigens (local injection), optional co-therapy with immune checkpoint inhibitors (monoclonal antibodies to PD‑1/PD‑L1/CTLA‑4). Mechanism: mRNA is taken up by antigen‑presenting cells (e.g., dendritic cells), translated to neoantigen peptides, and presented on MHC I/II, priming/expanding tumor‑specific CD8+ cytotoxic and CD4+ helper T cells to kill neoantigen‑bearing tumor cells. Checkpoint inhibitors block PD‑1/PD‑L1 and CTLA‑4 inhibitory pathways to enhance T‑cell activation and effector function. Targets: APC antigen‑presentation/MHC pathways, TCR signaling, tumor cells with selected neoantigens, and immune checkpoints PD‑1, PD‑L1, CTLA‑4.