OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer

NCT05248789 | Terminated Phase 2

• 1 other identifier: BH-OH2-017
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This Ⅱ study evaluates the safety and efficacy of intratumoral injection of OH2 in locally advanced or metastatic bladder cancer. 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

Advanced Bladder Carcinoma

Keywords

Oncolytic Virus

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The assessment result is the number and proportion of subjects with complete response + partial response.

  2 years

Secondary Outcomes (3)

• Disease Control Rate

  2 years

• Progression-Free Survival

  2 years

• Overall Survival

  5 years

Study Arms (1)

OH2

EXPERIMENTAL

OH2 dosage: 1x10e7 CCID50/mL Administration：intratumoral injection Frequency：once two weeks

Biological: OH2 injection

Interventions

OH2 injection BIOLOGICAL

OH2: Oncolytic Type 2 Herpes Simplex Virus

OH2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to sign informed consent, willing to follow the study procedures.
• Age 18 \~ 75 years old (including boundary value), male or female.
• ECOG 0-1.
• Histologically or cytologically confirmed advanced bladder cancer，relapsed and metastasized after radiotherapy or immunotherapy.
• Life expectancy \>12 weeks.
• Agree to provide last surgical specimens (including paraffin blocks, paraffin embedded sections, etc.).
• At least 6 weeks after previous anti-tumor treatment (radiotherapy, chemotherapy and immunotherapy) and the first administration of this trial.
• Appropriate organ function and hematopoietic function: neutrophil count (neut ≥ 1.5 × 109/L； White blood cell count (WBC) ≥ 3.0 × 109/L； Platelet count ≥ 100 × 109/L； Hemoglobin ≥ 90g / L; Serum creatinine ≤ 1.5 times the upper limit of normal value (ULN); AST and alt ≤ 2.5 times ULN; Serum total bilirubin ≤ 1.5 times ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (except for patients undergoing anticoagulant therapy).
• Agree to take effective contraceptive measures during treatment and at least 180 days after the last treatment.

You may not qualify if:

• The primary tumor was upper urinary tract and ureteral urothelial carcinoma.
• Malignant tumors other than bladder urothelial carcinoma within 5 years before enrollment.
• except:
• ①Prostate cancer with local low risk (stage ≤ T2b, Gleason score ≤ 7, PSA ≤ 20ng / ml, no recurrence after treatment (judged by reviewing PSA level)).
• ②Low risk prostate cancer (stage T1 / T2a, Gleason score ≤ 7, and PSA ≤ 10NG / ml, in the observed but untreated stage.
• Active autoimmune diseases and need systemic treatment in the past two years (i.e. long-term use of corticosteroids or immunosuppressive drugs). Alternative therapies (such as thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are excluded.
• Expected to have major surgery during the study period or had major surgery within 4 weeks before administration.
• Received other vaccines within 30 days before the first administration (including new crown vaccine)
• Any immune related toxicity caused by previous cancer treatment did not return to ≤ grade 1 (except for grade 2 endocrine system diseases receiving stable dose hormone replacement therapy), and / or any other toxicity related to previous anti-cancer treatment (except immune related toxicity) did not return to ≤ grade 2, except hair loss.
• Human immunodeficiency virus (HIV) seropositive or history of HIV infection or other acquired immunodeficiency diseases.
• Long-term use of antiviral drugs, including hepatitis B (HBsAg positive and HBV DNA equal to 2000 IU/ml at the same time, and excluding hepatitis or other causes of hepatitis), hepatitis C (at the same time to meet the anti HCV antibody positive, and HCV-RNA fruit is greater than the lower limit).
• Uncontrolled systemic diseases, such as cardiovascular and cerebrovascular diseases and diabetes.
• History of organ transplantation or stem cell transplantation.
• Cardiac insufficiency (patients classified as III-IV according to NY-HA of New York Heart Association).
• Lung disease (such as shortness of breath during rest or slight activity or oxygen supplement for any reason).

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 21, 2022
• Study Start: May 25, 2022
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: August 3, 2025

Record last verified: 2024-08

Locations

CN (1)