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

NCT05232136 | Recruiting Phase 1

• 1 other identifier: BH-OH2-016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Non-muscle-invasive Bladder Cancer

Keywords

Oncolytic Virus

Outcome Measures

Primary Outcomes (4)

• AEs

  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.

  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.

  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.

  12 months

• Rate of disease progression

  Time after OH2 administration to clinical and radiographic disease progression will be evaluated.

  1 years

Study Arms (1)

OH2

EXPERIMENTAL

This arm include two doses (1x10e6, 1x10e7 CCID50/mL) of OH2 injection，the 1x10e6 CCID50/mL dose group should be delivered before the 1x10e7 CCID50/mL dose group.

Biological: OH2 injection

Interventions

OH2 injection BIOLOGICAL

OH2: Oncolytic Type 2 Herpes Simplex Virus

OH2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

JianZhong Shou, MD

CONTACT

13601332989; shoujzh@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 9, 2022
• Study Start: July 11, 2022
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

CN (1)