Clinical Trial

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

Recruiting Phase 1/2
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Record status
This record was last updated August 12, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-02-07; most recent amendment 2024-08-09.
Status change: Not Yet Recruiting → Recruiting 2022-07-12
Trial Details
NCT Number NCT05232136
Lead Sponsor Binhui Biopharmaceutical Co., Ltd.
Conditions Non-muscle-invasive Bladder Cancer
Enrollment 30 participants
Start Date 2022-07-11
Primary Completion 2025-06 (estimated)
Study Completion 2025-10 (estimated)
Updated on ClinicalTrials.gov 2024-08-12