RecruitingPhase 1Phase 2NCT05232136

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

Oncolytic Virus (OH2) Adjuvant Therapy After Transurethral Resection of Bladder Tumor in Non-Muscle-Invasive Bladder Cancer Who Have Failed First-line Prophylactic Intravesical Instillation Therapy: a Phase Ⅰb/Ⅱ Clinical Trial


Sponsor

Binhui Biopharmaceutical Co., Ltd.

Enrollment

30 participants

Start Date

Jul 11, 2022

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an oncolytic virus therapy called OH2 — a virus that selectively infects and kills cancer cells while also stimulating the immune system — delivered directly into the bladder for patients with high-risk non-muscle-invasive bladder cancer that has not responded to standard treatments. **You may be eligible if...** - You are between 18 and 80 years old - You have high-grade non-muscle-invasive bladder cancer (Ta, T1, or Tis stage) - Your cancer has failed standard bladder instillation therapy (such as BCG) - You still have your bladder (or are not a candidate for bladder removal surgery for other reasons) **You may NOT be eligible if...** - Your cancer has grown into the bladder muscle or spread beyond the bladder - You have active serious infections - You have severe immune system problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOH2 injection

OH2: Oncolytic Type 2 Herpes Simplex Virus


Locations(1)

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

Beijing, Beijing Municipality, China

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NCT05232136