Advanced Malignant Solid Tumors
Conditions
Interventions
Case series:personalized mRNA cancer vaccine
Sponsors
Dongfang Hospital Affiliated to Shanghai Tongji University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old male and female; 2. Patients with metastatic or locally advanced malignant solid tumors diagnosed by histopathology or cytology, standard treatment failure or no standard treatment; 3. According to the solid tumor evaluation criteria (RECIST) version 1.1, at least one measurable tumor lesion; 4. normal blood system, liver and kidney function: lymphocyte number = 0.8 × 10^9/L, absolute neutrophil number = 1.5 × 10^9/L, hemoglobin = 9g/dL, platelets = 75 × 10^9/L; ALT = 3 times ULN, AST = 3 times ULN, serum creatinine = 1.5 times ULN; activated partial thromboplastin time (APTT) = 1.5 times ULN, prothrombin time (PT) = 1.5 times ULN, international normalized ratio (INR) ) = 1.5 times ULN; 5. ECOG score 0~1; 6. Patients with fertility must agree to use reliable methods of contraception (hormone or barrier or abstinence) during the trial and at least 12 weeks after the last treatment; 7. The patient himself voluntarily participates and signs the informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. Those who have had a history of allergies to biopharmaceuticals; 2. Those who are pregnant or breastfeeding; 3. Those with a predicted survival period of less than 6 months; 4. active or uncontrolled infections requiring systemic treatment; 5. Tumor mutation burden (TMB) 150mmHg, diastolic blood pressure > 90mmHg); 9. Patients with clinically symptomatic central nervous system metastasis and / or cancerous meningitis (patients with stable brain metastases can be enrolled), clinically suspected central nervous system or pia mater transfer should be excluded by CT / MRI; 10. Patients with active ulcers and gastrointestinal bleeding; 11. Those with clinically diagnosed autoimmune diseases; 12. those with HIV infection; those with acute EBV or CMV virus infection; 13. Patients with active replication of hepatitis B virus (DNA > 500 cps/mL), patients with hepatitis C; 14. Those who have received allogeneic bone marrow transplants in the past; 15. Subjects with immunosuppression, including known immunodeficiency; those currently on systemic use of steroids (except those who have recently or recently used inhaled steroids); 16. Skin diseases (such as psoriasis) may affect the intradermal injection of vaccine into the target area; 17. those who are known to have alcohol or drug dependence; 18. The investigator assessed that there were abnormalities in the history or disease, treatment, or experimental values that might prevent the subject from participating in the study throughout the study, or that participating in the study did not meet the best interests of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specific CD4 + and CD8 + T lymphocyte responses to neoantigen; | — |
Secondary
| Measure | Time frame |
|---|---|
| CT/MRI examination of thoracic, abdominal and pelvic region;Comprehensive physical examination;Vital signs;Complaint symptom;routine blood test;Urine routine test;blood biochemistry;Four items of blood coagulation;electrocardiogram; | — |
Countries
China
Contacts
Public ContactLi Jin
Stemirna Therapeutics LLC
Outcome results
None listed