IMP3-saRNA Vaccine in Advanced NSCLC

Exclusion criteria

• ✕. 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.
• ✕. 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.
• ✕. Any active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurologic disease, multiple sclerosis, autoimmune demyelinating neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome, except type 1 diabetes mellitus controlled with a stable dose of insulin. Participants with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be enrolled; participants with asthma requiring medical intervention with bronchodilators are not eligible.
• ✕. 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.
• ✕. 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.
• ✕. 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.
• ✕. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation.
• ✕. Prior antitumor therapeutic vaccine or cellular immunotherapy.