NCT05235074

OH2 Oncolytic Viral Therapy in Central Nervous System Tumors

A Clinical Study of Oncolytic Virus (OH2) Injection in the Treatment of Patients Undergoing Surgery After Recurrence of Central Nervous System Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Binhui Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Central Nervous System Tumors

Interventions

Type	Name	Description
BIOLOGICAL	OH2 injection	OH2: Oncolytic Type 2 Herpes Simplex Virus

Timeline

• Start date: 2021-11-16
• Primary completion: 2026-06-16
• Completion: 2026-06-16
• First posted: 2022-02-10
• Last updated: 2025-07-25

Locations

1 site across 1 country: China