NSCLC
Conditions
Interventions
50µg:Injection of 50µg lipid-encapsulated mRNA vaccine
150µg:Injection of 150µg lipid-encapsulated mRNA vaccine
450µg:Injection of 450µg lipid-encapsulated mRNA vaccine
1000µg:Injection of 1000µg lipid-encapsulated mRNA vaccine
Dose Expansion:Based on the safety data obtained from cohort 1, select the recommended dose for the study, administer injections in weeks 1, 2, 3, 4, 6, 8, 10, and 12 of the vaccine treatment period,
Sponsors
Gulou Hospital Affiliated to Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joins this study and signs the informed consent form; 2. Age = 18 years, both male and female eligible; 3. Cohort 1: IB-IIIA stage NSCLC confirmed by surgical histopathology after radical surgery, regardless of whether 4 cycles of postoperative adjuvant chemotherapy, adjuvant immunotherapy, or adjuvant targeted therapy have been received; Cohort 2: advanced NSCLC with driver gene positivity confirmed by histology or cytology, including mutations in EGFR, ALK, ROS-1, BRAF, RET, c-MET, etc.; and previous systemic chemotherapy not administered (patients who received chemotherapy while awaiting gene test results or received postoperative adjuvant chemotherapy more than 6 months ago can be included); and first-line combined targeted therapy; 4. ECOG performance status: 0-1; 5. Expected survival = 6 months for advanced patients; 6. Important organ functions meet the following requirements: (1) Absolute neutrophil count = 1.5 x 10^9/L; (2) Absolute lymphocyte count = 0.8 x 10^9/L; (3) Platelets = 80 x 10^9/L; (4) Hemoglobin = 90 g/L; (5) Bilirubin = 1.5 x ULN (within 7 days prior to first administration); (6) ALT and AST = 1.5 x ULN (within 7 days prior to first administration); (7) Serum creatinine = 1.5 x ULN; 7. Thyroid-stimulating hormone (TSH) = 1 x ULN (if abnormal, FT3 and FT4 levels should also be assessed; if FT3 and FT4 are normal, the patient can be enrolled); 8. Female patients of childbearing potential who are not surgically sterilized should use one medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment and for 3 months after completion of the study treatment; serum or urine HCG tests must be negative within 72 hours before enrollment for these women; they must also not be breastfeeding; male patients with partners of childbearing potential should use effective contraception during the trial and for 3 months after the last administration of study drug; 9. Agree to provide blood samples and tissue specimens.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that completely resolved in childhood and requires no intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included); 2. The patient is using immunosuppressants or systemic steroid therapy to achieve immunosuppression (dose > 10 mg/day prednisone or equivalent steroids), and continues to use them within 2 weeks before enrollment; 3. Has had a severe allergic reaction to other immunotherapy drugs; 4. Has hypertension that cannot be well controlled with antihypertensive medications (systolic BP >= 140 mmHg or diastolic BP >= 90 mmHg); 5. Has uncontrolled cardiac clinical symptoms or disease, such as: (1) NYHA class 2 or above heart failure; (2) Unstable angina; (3) Myocardial infarction within the past year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc > 450 ms (male); QTc > 470 ms (female); 6. Coagulation disorders (INR > 2.0, PT > 16 s), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin or low molecular weight heparin is allowed; 7. The patient has an active infection, unexplained fever >= 38.5°C within 7 days before medication, or baseline white blood cell count > 15 x 10^9/L; or has purulent or chronic infection, with wounds that heal poorly; 8. The patient has previously received tumor vaccine treatment; 9. Pregnant or breastfeeding women, or women of childbearing potential who are not using contraception; 10. Has had other malignancies in the past 5 years (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, or breast cancer); 11. Patients who are simultaneously participating in other clinical trials; 12. HIV positive; HCV positive; uncontrolled active hepatitis B; 13. Received live vaccine within 4 weeks before the start of treatment; 14. According to the investigator's opinion, other severe, acute, or chronic medical diseases, psychiatric disorders, or laboratory abnormalities that may increase risk for participating in the study or may interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose;adverse effect ;Responses of naive antigen-specific CD4 and CD8 T lymphocytes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (PFS, ORR, DCR, OS); | — |
Countries
China
Contacts
Public ContactWang Tao
Gulou Hospital Affiliated to Nanjing University Medical School
Outcome results
None listed