Actively Recruiting
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer
Led by Binhui Biopharmaceutical Co., Ltd. · Updated on 2024-08-12
30
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old, male or female
- Failed first-line preventive bladder instillation therapy and retained the bladder or unsuitable for radical cystectomy
- Diagnosed with Ta, T1, or Tis high-grade non-muscle-invasive bladder cancer
- Negative bladder mucosa biopsy histology and pathology and negative postoperative urine cytology during TURBT
- No tumor found in upper urinary tract examination
- No prior systemic chemotherapy or radiation therapy for bladder cancer
- ECOG performance status of 0 or 1
- Estimated survival time greater than 1 year
- Laboratory values meeting specific criteria for WBC, ANC, platelets, hemoglobin, kidney and liver function, and coagulation
- Effective contraception during treatment and for 3 months after
- At least 3 months since last herpes infection
- Voluntary informed consent and expected compliance
You will not qualify if you...
- Muscle-invasive bladder cancer or bladder cancer with clinical metastasis
- Complications after TURBT or inability to perform perfusion therapy
- Allergy to GM-CSF products or study drug components
- Serious medical conditions including severe heart disease, cerebrovascular disease, uncontrolled diabetes or hypertension, severe infection, or active gastrointestinal ulcer
- Expected chemotherapy or radiotherapy during the study
- Active infection or fever above 38.5 C at screening or before first dose; ongoing urinary tract infection especially bladder infection unless controlled and resolved
- Congenital or acquired immune deficiency, including HIV infection; active Hepatitis B or C infection
- Pregnant or lactating women
- Use of other experimental drugs or antiviral therapy within 4 weeks before treatment
- Immunosuppressive therapy in the last 3 months
- Participation in cancer vaccine trials in the last 12 months
- History of psychotropic substance, alcohol, or drug abuse
- Other malignant tumors within 5 years except certain well-treated cancers
- Active autoimmune diseases or history of autoimmune diseases with potential relapse, except specific controlled conditions
- Use of systemic corticosteroids within 14 days before study drug administration, except certain local or short-term uses
- Investigator judgment of unsuitability for study participation for any reason
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
J
JianZhong Shou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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