Actively Recruiting
OH2 Oncolytic Viral Therapy in Central Nervous System Tumors
Led by Binhui Biopharmaceutical Co., Ltd. · Updated on 2025-07-25
28
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
OH2 Oncolytic Viral Therapy in Central Nervous System Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Pathologically confirmed recurrent central nervous system tumors (Phase I) or recurrent glioblastoma (Phase IIa) after surgery
- Karnofsky Performance Score (KPS) of 60 or higher
- Partial or complete tumor resection with Ommaya reservoir placed for drug administration
- Injection site expected to be in the supratentorial brain area
- Life expectancy of 3 months or more
- Adequate blood counts: WBC 3.0�d7 10^9/L, ANC 1.5�d7 10^9/L, PLT 100�d7 10^9/L, Hb 9.0 g/dL or higher
- Adequate liver and kidney function according to specified lab limits
- Acceptable coagulation function: INR and APTT 1.5 times the upper limit of normal
- Negative pregnancy test for women of childbearing age within 14 days before enrollment
- Use of effective contraception by female subjects and their partners during and for 6 months after treatment
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Participation in another clinical trial within 28 days before enrollment
- Recent chemotherapy, targeted therapy, or immunotherapy within 28 days before first use of OH2
- Use of traditional or modern Chinese medicine and antiviral drugs within 7 days before first use of OH2
- Brain radiotherapy within 3 months before first use of OH2
- Active extracranial cancers requiring treatment
- Known allergy to the study drug or its ingredients
- History of or planned organ/tissue transplantation
- Active infection or unexplained fever above 38.5 C during screening or before first dose
- Active pulmonary tuberculosis treated or under treatment within 1 year
- Positive for HIV, HCV, or active hepatitis B with specific criteria
- Significant cardiovascular disease as detailed in criteria
- Active or potentially relapsing autoimmune diseases except certain controlled conditions
- Unstable mental illness or substance abuse
- Pregnancy, breastfeeding, or expected pregnancy during study period
- Unrecovered adverse reactions from previous anti-tumor therapy above grade 1 except alopecia
- Any serious uncontrolled disease or condition making participation unsuitable
- Other conditions judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
W
Wenbin Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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