Locally advanced or advanced non-small cell lung cancer with (progression after)/ (failed) second-line or higher standard therapy
Conditions
Interventions
The first dose:YMN-V138 vaccine,30ug per injection
The Second dose:YMN-V138 vaccine,60ug per injection
The Third dose group:YMN-V138 vaccine,90ug per injection
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form(1) Clinical research participants must sign a written informed consent form approved by the ethics committee, in accordance with the regulations and institutional guidelines ; (2)The informed consent form must be signed and dated prior to any study-related procedures that are not part of routine clinical care for the clinical research participants.(2).Clinical research participants must be willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other requirements of the study; 2. Male or female clinical research participants: >=18 years old =10 mm on CT scan, and lymph node lesions with a short axis >=15 mm on CT scan, using a slice thickness of = 3 months; 8. Toxicities from previous anti-tumor treatments has recovered to = 90 g/L (no blood transfusions within 14 days); Neutrophil count > 1.5 × 10^9/L; Platelet count >= 80 × 10^9/L;• Biochemical examination: Total bilirubin = 50 ml/min (Cockcroft-Gault formula) or creatinine level = 50%.• QTcF interval, male <= 470 ms, female <= 450 ms, QTc interval calculated using Fridericia's formula; 10. Premenopause women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation, and must not be breastfeeding; all participants in the clinical study (regardless of gender) should apply effective barrier contraception throughout treatment and for 12 months after its ends; 11. Good compliance and willingness to the entire research visit process (including
Exclusion criteria
Exclusion criteria: 1.Received other unapproved clinical trial drugs or treatments within 4 weeks prior to enrollment; 2. Clinical trial participants with a history of other malignancies, except for situ cervical cancer, treated skin squamous cell carcinoma, bladder epithelial tumors, or other malignant tumors that have already undergone curative treatment (at least 5 years prior to enrollment); 3. History of severe cardiovascular or cerebrovascular diseases, such as: NYHA class II or higher heart failure, acute coronary syndrome (unstable angina, myocardial infarction, etc.) and acute cerebrovascular disease (such as cerebral infarction, cerebral hemorrhage, etc.)within 6 months before screening, frequent and uncontrolled severe arrhythmias; 4. History of autologous or allogeneic stem cell transplantation; 5. Active pulmonary tuberculosis or presence of active severe infection within 14 days prior to enrollment; HIV infection, active HBV infection (positive hepatitis B surface antigen and HBV-DNA > 500 IU/ml), active HCV infection; 6. History of substance abuse or severe neurological/psychiatric disorders (e.g., alcoholism, depression, schizophrenia, epilepsy); 7. Clinical research participants who have any active autoimmune disease or a history of autoimmune disease (including but not limited to: dermatomyositis, rheumatoid arthritis, systemic lupus erythematosus, etc.); participants with vitiligo or those whose childhood asthma has completely resolved without any intervention in adulthood can be included; those requiring bronchodilators are excluded); 8. Any abnormalities or permanent body art (such as tattoos) at the vaccination site that may interfere with local reaction assessment; 9. History or evidence of interstitial lung disease requiring glucocorticoid therapy, or suspected interstitial lung disease; 10. Unstable central nervous system metastases, meningeal metastases, or spinal cord compression; 11. Previous use of chemotherapy, targeted therapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, extensive radiotherapy (more than 30% bone marrow) within 4 weeks or 5 half-lives (whichever is shorter), or palliative radiotherapy (allowing for palliative radiotherapy to bone lesions) within 2 weeks; 12. Planned or received a live vaccine within 28 days; 13. Contraindications tointramuscular injections; 14. Known allergies and hypersensitivity reactions to vaccine research (including any adjuvants), or history of severe allergic reactions to any drugs, foods, or vaccines, such as anaphylaxis, angioedema, dyspnea, purpura, Arthus reaction, etc; 15. Any other severe medical condition that, in the investigator’s judgement, may compromise subject safety or interfere with study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Disease control rate(DCR);Duration of response(DOR);Preliminary exploration produces CRIPTO-1 specific immune response.;Progression free survival(PFS);Overall survival(OS); | — |
Countries
China
Contacts
Public ContactMeijuan Huang
West China Hospital of Sichuan University
Outcome results
None listed