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.
This is a phase Ⅰb/Ⅱ study evaluating the safety and efficacy of OH2 in non-muscle-invasive bladder cancer. BH-OH2-016 is a single-arm,multicenter clinical trial. After screening, The treatment period includes induction treatment period and maintenance treatment period. In the induction treatment period, OH2 will be delivered once two weeks. In the maintenance treatment period, OH2 will be delivered once a month. In this trial, two doses (1x10e6, 1x10e7 CCID50/mL) of OH2 will be delivered intravesical instillation,and the 1x10e6 CCID50/mL dose group should be delivered before the 1x10e7 CCID50/mL dose group. Adverse events (AEs) are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).Urine cytology/Cystoscopy/ultrasonography of urinary system will be used for disease recurrence examination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
OH2: Oncolytic Type 2 Herpes Simplex Virus
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGAEs
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.
Time frame: 1 years
Relapse Free Survival Rate at 6 months
The assessment result is the number and proportion of subjects with relapse free survival at 6 months.
Time frame: 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.
Time frame: 12 months
Rate of disease progression
Time after OH2 administration to clinical and radiographic disease progression will be evaluated.
Time frame: 1 years
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