OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer

Inclusion Criteria

• •1. Agree to sign informed consent, willing to follow the study procedures.
• •2. Age 18 \~ 75 years old (including boundary value), male or female.
• •3. ECOG 0-1.
• •4. Histologically or cytologically confirmed advanced bladder cancer，relapsed and metastasized after radiotherapy or immunotherapy.
• •5. Life expectancy \>12 weeks.
• •6. Agree to provide last surgical specimens (including paraffin blocks, paraffin embedded sections, etc.).
• •7. At least 6 weeks after previous anti-tumor treatment (radiotherapy, chemotherapy and immunotherapy) and the first administration of this trial.
• •8. Appropriate organ function and hematopoietic function: neutrophil count (neut ≥ 1.5 × 109/L； White blood cell count (WBC) ≥ 3.0 × 109/L； Platelet count ≥ 100 × 109/L； Hemoglobin ≥ 90g / L; Serum creatinine ≤ 1.5 times the upper limit of normal value (ULN); AST and alt ≤ 2.5 times ULN; Serum total bilirubin ≤ 1.5 times ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (except for patients undergoing anticoagulant therapy).
• •9. Agree to take effective contraceptive measures during treatment and at least 180 days after the last treatment.
• •3. Active autoimmune diseases and need systemic treatment in the past two years (i.e. long-term use of corticosteroids or immunosuppressive drugs). Alternative therapies (such as thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are excluded.
• •4. Expected to have major surgery during the study period or had major surgery within 4 weeks before administration.
• •5. Received other vaccines within 30 days before the first administration (including new crown vaccine)
• •6. Any immune related toxicity caused by previous cancer treatment did not return to ≤ grade 1 (except for grade 2 endocrine system diseases receiving stable dose hormone replacement therapy), and / or any other toxicity related to previous anti-cancer treatment (except immune related toxicity) did not return to ≤ grade 2, except hair loss.
• •7. Human immunodeficiency virus (HIV) seropositive or history of HIV infection or other acquired immunodeficiency diseases.
• •8. Long-term use of antiviral drugs, including hepatitis B (HBsAg positive and HBV DNA equal to 2000 IU/ml at the same time, and excluding hepatitis or other causes of hepatitis), hepatitis C (at the same time to meet the anti HCV antibody positive, and HCV-RNA fruit is greater than the lower limit).
• •9. Uncontrolled systemic diseases, such as cardiovascular and cerebrovascular diseases and diabetes.
• •10. History of organ transplantation or stem cell transplantation.
• •11. Cardiac insufficiency (patients classified as III-IV according to NY-HA of New York Heart Association).
• •12. Lung disease (such as shortness of breath during rest or slight activity or oxygen supplement for any reason).
• •13. Other basic diseases which would interfere with the diagnosis of the disease, or might potentially cause serious complications
• •14. Other serious infections before administration
• •15. Alcohol addicts or history of drug abuse.
• •16. History of neurological or mental disorders, such as epilepsy, dementia, poor compliance, or peripheral nervous system disorders.
• •17. Pregnancy or lactation, or expected pregnancy or childbirth during the trial period.
• •18. Allergic to study drug or have a history of allergic reaction to the main and auxiliary materials of any dosage form in the study drug.