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RECRUITING
NCT05235074
PHASE1/PHASE2

OH2 Oncolytic Viral Therapy in Central Nervous System Tumors

Sponsor: Binhui Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2021-11-16

Completion Date

2026-06-16

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

BIOLOGICAL

OH2 injection

OH2: Oncolytic Type 2 Herpes Simplex Virus

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China