OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer

  • STATUS
    Recruiting
  • End date
    Oct 22, 2023
  • participants needed
    30
  • sponsor
    Wuhan Binhui Biotechnology Co., Ltd.
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Updated on 4 October 2022
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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 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.

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 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.

Details
Condition Non-muscle-invasive Bladder Cancer
Treatment OH2 injection
Clinical Study IdentifierNCT05232136
SponsorWuhan Binhui Biotechnology Co., Ltd.
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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