Actively Recruiting
Oncolytic Virus OH2 Therapy After Bladder Tumor Removal in Non-Muscle-Invasive Bladder Cancer Patients Who Failed First-Line Preventive Therapy
Led by Binhui Biopharmaceutical Co., Ltd. · Updated on 2024-08-12
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of OH2, an oncolytic virus based on herpes simplex virus type 2, for treating non-muscle-invasive bladder cancer that has not responded to first-line preventive bladder treatments. This phase 1b/2 clinical trial aims to explore OH2 as an additional therapy to help control the cancer and boost the immune system's anti-tumor response. The study involves a single group of participants receiving OH2 through bladder instillations. The treatment has two stages: an induction period where OH2 is given every two weeks, followed by a maintenance period with monthly treatments. Two different virus doses are tested, starting with the lower dose before moving to the higher one. The virus is delivered directly into the bladder to target tumor cells. Participants will be monitored regularly for side effects and cancer recurrence using urine tests, bladder examinations, and ultrasound imaging of the urinary system. Researchers will assess safety, relapse-free survival at 6 and 12 months, and disease progression over a year. The study includes laboratory tests to check blood counts and organ function, and participants will be followed for at least one year after treatment.
CONDITIONS
Brief 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, male or female
- Failed first-line preventive bladder perfusion therapy and retained bladder or unsuitable for cystectomy
- Diagnosed with Ta, T1, or Tis high-grade non-muscle-invasive bladder cancer
- Negative bladder mucosa biopsy and urine cytology after tumor removal
- No tumor found in upper urinary tract examination
- No prior systemic chemotherapy or radiation for bladder cancer
- ECOG performance status 0-1
- Estimated survival time more than 1 year
- Laboratory tests within specified normal ranges for blood counts, kidney and liver function, and coagulation
- Use of effective contraception during and within 3 months after treatment
- 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 metastatic bladder cancer
- Complications after tumor removal preventing perfusion therapy
- Allergy to GM-CSF products or study drug components
- Serious medical conditions such as severe heart disease, stroke, uncontrolled diabetes or hypertension, severe infection, or active ulcers
- Planned 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 resolved after antibiotics
- Immune deficiency, active hepatitis B or C infection
- Pregnant or lactating
- Use of other experimental drugs or antiviral therapy within 4 weeks before treatment
- Use of immunosuppressive therapy within 3 months before treatment
- Participation in cancer vaccine trials within 12 months
- History of substance abuse
- Other cancers within 5 years except certain low-risk tumors
- Active or relapsing autoimmune diseases except specified controlled conditions
- Use of systemic corticosteroids within 14 days before treatment except certain local or short-term uses
- Any reason investigator judges participant unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction period followed by maintenance period up to 1 year
Participants receive OH2 oncolytic viral therapy through intravesical instillation in two parts: an induction treatment period with doses delivered once every two weeks, followed by a maintenance treatment period with doses delivered once a month.
Biweekly visits during induction and monthly visits during maintenance
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
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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