Status:
RECRUITING
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer
Lead Sponsor:
Binhui Biopharmaceutical Co., Ltd.
Conditions:
Non-muscle-invasive Bladder Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 on...
Detailed Description
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 perio...
Eligibility Criteria
Inclusion
- 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.
- No tumor was found in upper urinary tract examination; No systemic chemotherapy or radiation therapy for bladder cancer has been done at any time before.
- ECOG 0-1.
- The estimated survival time is more than 1 year.
- Laboratory inspection:
- WBC≥3.5 × 10\^9／L，ANC≥1.5 × 10\^9／L，PLT≥80 × 10\^9／L，Hb≥90g/L；
- Blood bun and serum creatinine were within 1.5 times of the upper limit of normal value;
- TBIL ≤ 1.5 times the upper limit of normal value;
- ALT and AST ≤ 2.5 times the upper limit of normal value;
- The coagulation function is normal (PT and APTT are within 1.5 times of the upper limit of normal value).
- Received effective contraception during and within 3 months after treatment.
- At least 3 months after the end of herpes infection.
- Voluntary signing of informed consent, expected patient compliance
Exclusion
- 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.
- Chemotherapy or radiotherapy is expected to be used during the study.
- Active infection or fever of unknown cause \> 38.5 ℃ during screening and before the first administration. Ongoing urinary system infection, especially bladder infection (if the infection can be controlled by antibiotics, except that it can return to normal after 7 days of antibiotic withdrawal).
- Congenital or acquired immune deficiency (such as HIV infection) , Hepatitis B infection of HBV-DNA or more than 10 /mL, HCV antibody and HCV RNA positive in hepatitis C infection.
- Pregnant or lactating.
- Other experimental drugs or antiviral therapy were used or are being used within 4 weeks before treatment.
- Participated in immunosuppressive therapy in recent 3 months, including cyclosporine, antithymocyte globulin or tacrolimus.
- Participated in cancer vaccine treatment trials in recent 12 months (such as dendritic cell therapy and heat shock vaccine).
- History of psychotropic substance abuse, alcoholism or drug abuse.
- Other malignant tumors within 5 years before enrollment, except effectively resected cervical carcinoma in situ, low-risk gastrointestinal stromal tumor, skin basal cell carcinoma, skin squamous cell carcinoma, thyroid papillary carcinoma and breast ductal carcinoma in situ.
- Active autoimmune diseases or history of autoimmune diseases and may relapse, except:
- Type I diabetes mellitus;
- Hypothyroidism (if only controlled by hormone replacement therapy);
- Controlled celiac disease;
- Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, hair loss);
- Any other disease that will not recur without external triggers.
- Using corticosteroids within 14 days before the administration of the study drug due to treatment, or suffering from any disease requiring systemic treatment with other immunosuppressants, except:
- Local, ophthalmic, intra-articular, intranasal or inhaled corticosteroids with minimal systemic absorption;
- Prophylactic short-term use of corticosteroids (e.g., allergy to contrast agents) or for the treatment of non autoimmune diseases (e.g., delayed hypersensitivity caused by contact allergens).
- Not suitable to participate study judged by investigators for any reason.
Key Trial Info
Start Date :
July 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05232136
Start Date
July 11 2022
End Date
October 1 2025
Last Update
August 12 2024
Active Locations (1)
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1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021