OH2 Oncolytic Viral Therapy in Central Nervous System Tumors
NCT05235074 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-07-25
Summary
In the first phase, it mainly explores the safety, tolerability and preliminary effectiveness of two doses of OH2 injection in the treatment of patients with recurrent central nervous system tumors; to evaluate the biodistribution and virus shedding of OH2 injection administered in the tumor cavity; to evaluate the level of anti-HSV2 antibody in patients when OH2 injection is administered intracavitary to tumor; to determine the phase II recommended dose (RP2D) of OH2 injection in the treatment of recurrent glioblastoma.
Phase IIa, to evaluate the preliminary efficacy of OH2 injection in the treatment of patients with recurrent glioblastoma after surgery, and to further evaluate the safety of OH2 in the treatment of relapsed glioblastoma.
Conditions
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
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-16
- Primary Completion
- 2026-06-16
- Completion
- 2026-06-16
Countries
- China
Study Locations
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