IMP3-saRNA Vaccine in Advanced NSCLC

Exclusion Criteria

• •1. Patients with a history of other malignancies, except for malignancies considered eligible by the investigator, such as cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or intramucosal gastrointestinal carcinoma without recurrence within 5 years before screening.
• •2. Any uncontrolled clinical disease, such as respiratory, circulatory, digestive, neurologic, hematologic, genitourinary, or endocrine disease, or psychiatric disease, such as depression or schizophrenia, or other major disease that, in the investigator's judgment, may interfere with provision of informed consent, interfere with interpretation of study results, pose a risk to the participant by participating in this study, or otherwise affect achievement of the study objectives.
• •4. Patients with active central nervous system metastases, including but not limited to carcinomatous meningitis and spinal cord compression, must be excluded. However, patients with metastatic central nervous system tumors may participate in this study if they have recovered to baseline for at least 2 weeks before enrollment, with no residual signs or symptoms related to central nervous system treatment. In addition, patients must have discontinued corticosteroids for 4 weeks.
• •5. Allergy to the study drug, including any excipients. History of severe allergy to any drug, food, or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, or local allergic necrotic reaction, such as Arthus reaction.
• •6. Contraindications to injection: a. inflammation, trauma, or ulceration at the injection site; b. severe bleeding or coagulation tendency, or marked decrease in platelets or coagulation factors; c. any abnormality or permanent body art, such as a tattoo, at the vaccination site that, in the investigator's judgment, may interfere with observation of local reactions at the vaccination site.
• •7. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation.
• •8. Prior antitumor therapeutic vaccine or cellular immunotherapy.
• •9. Participation in another drug or device clinical trial within 4 weeks before screening.
• •10. Major surgery within 4 weeks before the first vaccination, except for minor procedures such as catheter placement or protocol-required biopsy; or insufficient resolution of the effects of surgery or trauma for at least 14 days before enrollment.
• •11. Participants who have received systemic treatment with corticosteroids at a dose \>10 mg/day prednisone or an equivalent dose of another glucocorticoid, or other immunosuppressive agents, within 14 days before the first vaccination. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal hormone replacement therapy at a dose ≤10 mg/day prednisone equivalent are allowed.
• •12. Any toxicity caused by previous antitumor therapy has not recovered to grade ≤1 according to NCI CTCAE version 5.0 before the first administration of the study drug, except for alopecia of any grade and grade 2 neuropathy related to prior platinum therapy.
• •13. Known hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis infection, or positive screening test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, HIV antibody, or Treponema pallidum antibody: HBsAg positivity or HBcAb positivity with HBV DNA quantitative test result ≥500 IU/mL or ≥2000 copies/mL, or meeting the lower limit of positivity at the study center; HCVAb positivity with HCV RNA ≥ the upper limit of normal at the study center.
• •14. Active tuberculosis, history of active tuberculosis, or severe acute or chronic infection requiring systemic treatment. Patients suspected of having active tuberculosis must undergo chest X-ray, sputum testing, and exclusion by clinical symptoms and signs. Patients with objective evidence of previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe impairment of pulmonary function are excluded.
• •15. History of drug abuse or known medical, psychological, or social conditions, such as alcoholism or drug addiction.
• •16. Pregnant or breastfeeding women, or female participants who plan to become pregnant or male participants whose partners plan to become pregnant from screening until 12 months after completion of all study drug injections.
• •17. Receipt of any vaccine within 30 days before vaccination with the study vaccine, or planned receipt of any vaccine other than the study vaccine during the study.
• •18. History of deep vein thrombosis or pulmonary embolism within 6 months before enrollment.
• •19. Uncontrolled fungal, bacterial, viral, or other infection requiring antibiotic treatment. Simple urinary tract infection or uncomplicated bacterial pharyngitis may be allowed after consultation with the medical monitor.
• •20. History or presence of central nervous system disease, such as seizure disorder, cerebral ischemia or hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system.
• •21. Significant immunodeficiency.
• •22. Negative tumor tissue IMP3 pathological test result or inability to obtain or confirm IMP3 status.
• •23. Any other factor that, in the investigator's judgment, makes the participant unsuitable for this study, or any disease that may interfere with safety or efficacy evaluation of the study treatment.
• •24. Participants who are unwilling or unable to comply with study requirements.