OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer
NCT05232136 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-08-12
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
Interventions
- BIOLOGICAL
-
OH2 injection
OH2: Oncolytic Type 2 Herpes Simplex Virus
Sponsors & Collaborators
-
Binhui Biopharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-11
- Primary Completion
- 2025-06-30
- Completion
- 2025-10-31
Countries
- China
Study Locations
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