Advanced non-small cell lung cancer
Conditions
Interventions
IMP3-saRNA (YMN-136) vaccine dose-escalation group:Three patients were grouped together and subjected to a "3+3" dose escalation test, with doses of 50 µ g, 100 µ g, and 200 µ g administered sequentia
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >18 years at screening, including the boundary value; voluntarily signs an informed consent form approved by the ethics committee before any study-related procedure and agrees to participate in this study. 2. Patients with histologically or cytologically confirmed non-small cell lung cancer who have failed, are intolerant to, or refuse standard therapy, and whose tumor tissue meets the protocol-defined IMP3 expression requirement. 3. At least one measurable or evaluable lesion according to RECIST v1.1. 4. ECOG performance status score of 0 to 2. 5. Estimated survival of at least 3 months. 6. Adequate major organ function, with hematologic, hepatic, renal, coagulation, and cardiac function parameters meeting the protocol requirements within 7 days before treatment. 7. Male participants with reproductive potential and women of childbearing potential agree to use effective contraception as required by the protocol; women must have a negative pregnancy test and agree to avoid pregnancy during the study period and within the protocol-defined period after the last dose. 8. The washout period from prior antitumor therapy, palliative radiotherapy, thoracic radiotherapy, and major surgery meets the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. History of other malignancies, except for protocol-allowed malignancies that have been adequately treated and have not recurred within 5 years before screening. 2. Uncontrolled clinical disease, psychiatric illness, or other conditions that, in the investigator’s judgment, may affect informed consent, interpretation of study results, study safety, or achievement of study objectives. 3. Active autoimmune disease or history of autoimmune disease, except for protocol-allowed exceptions. 4. Active central nervous system metastases, except for protocol-allowed stable CNS metastases. 5. Known allergy to the study drug or excipients, or a history of severe allergy to drugs, food, or vaccines. 6. Contraindications to injection. 7. History of organ transplantation or allogeneic hematopoietic stem cell transplantation. 8. Prior treatment with antitumor therapeutic vaccines 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, or surgery/trauma with insufficient recovery within 14 days before enrollment. 11. Use of systemic corticosteroids or other immunosuppressive agents within 14 days before the first vaccination, except for protocol-allowed situations. 12. Prior antitumor treatment-related toxicities have not recovered to NCI CTCAE v5.0 grade =1 before the first vaccination, except for protocol-allowed situations. 13. Protocol-defined positive test results for hepatitis B, hepatitis C, HIV, syphilis, or related infections. 14. Active pulmonary tuberculosis or history of active pulmonary tuberculosis, or severe acute/chronic infection requiring systemic treatment, or pulmonary fibrosis, interstitial pneumonia, or other protocol-defined pulmonary diseases. 15. History of drug abuse, or medical, psychological, or social conditions such as alcohol abuse or substance abuse. 16. Pregnant or lactating women, or participants who plan to become pregnant within 12 months after the last study drug injection from screening through the entire study period. 17. Receipt of any vaccine within 30 days before vaccination with the study vaccine, or planned receipt of other vaccines during the study period. 18. History of deep vein thrombosis or pulmonary embolism within 6 months before enrollment. 19. Uncontrolled fungal, bacterial, viral, or other infection requiring antimicrobial treatment, except for protocol-allowed situations. 20. CNS disease or disorder, including seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease involving the CNS. 21. Severe immunodeficiency. 22. Negative IMP3 pathological test result in tumor tissue, or inability to obtain or confirm IMP3 status. 23. Any other condition that, in the investigator’s opinion, makes the participant unsuitable for this trial or may interfere with the safety or efficacy evaluation of the study treatment. 24. Unwillingness or inability to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response, including complete response (CR) and partial response (PR);Overall survival (OS);Progression-free survival (PFS);Adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactXingchen Peng
West China Hospital of Sichuan University
Outcome results
None listed