This phase Ⅰb/Ⅱ study evaluates the safety and efficacy of OH2 for adjuvant therapy in non-muscle-invasive bladder cancer after first-line prophylactic intravesical instillation therapy.
OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.
Age 18 ~ 80 years old (including boundary value), male or female.
Failed in first-line preventive bladder perfusion therapy, and retained the bladder (or other reasons are not suitable for radical total cystectomy).
Ta, T1 or Tis with high grade (HG) of non-muscle-invasive bladder cancer.
Negative histology and pathology of bladder mucosa biopsy and negative postoperative urine cytology during TURBT.
muscle invasive bladder cancer or bladder cancer with clinical metastasis.
Complications occurred after TURBT, or perfusion therapy could not be performed.
Allergic to GM-CSF products or have a history of allergic reaction to the main and auxiliary materials of any dosage form in the study drug.
Suffering from serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active gastrointestinal ulcer.
Single group
OH2 injection
Biological/VaccineOH2: Oncolytic Type 2 Herpes Simplex Virus
AEs
All events with a Grade 3 or above toxicity (defined by the CTCAE v5.0) will be tabulated by event and by relationship to OH2.
Relapse Free Survival Rate at 6 months
The assessment result is the number and proportion of subjects with relapse free survival at 6 months.
Relapse Free Survival Rate at 12 months
The assessment result is the number and proportion of subjects with relapse free survival at 12 months.
Rate of disease progression
Time after OH2 administration to clinical and radiographic disease progression will be evaluated.
Click on the lead sponsor to view all of their trials.
