Clinical Trial

OH2 Oncolytic Viral Therapy in Central Nervous System Tumors

Completed Phase 1/2
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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.
Protocol Amendment History 4 changes
critical Trial completed 2026-08-06
notable Enrollment increased: 28 -> 40 participants 2026-08-06
notable Primary completion pushed: 2026-06-16 -> 2026-07-23 2026-08-06
minor Completion pushed: 2026-06-16 -> 2026-07-23 2026-08-06
Trial Details
NCT Number NCT05235074
Lead Sponsor Binhui Biopharmaceutical Co., Ltd.
Conditions Central Nervous System Tumors
Enrollment 40 participants
Start Date 2021-11-16
Primary Completion 2026-07-23 (estimated)
Study Completion 2026-07-23 (estimated)
Updated on ClinicalTrials.gov 2026-08-05