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Central Nervous System TumorsPhase 1/2NCT05235074

OH2 Oncolytic Viral Therapy in Central Nervous System Tumors

A Phase 1/2 study testing OH2 injection in people with Central Nervous System Tumors, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Central Nervous System Tumors
What is being tested?
OH2 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
16 Nov 2021to 23 Jul 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old, male or female;
  • Phase I trials select pathologically confirmed recurrent central nervous system tumors (including but not limited to anaplastic astrocytoma, anaplastic oligoastrocytoma, glioblastoma, gliosarcoma, anaplastic ependymoma, Medulloblastoma, malignant meningioma, melanoma, etc.) postoperative patients; Phase IIa trial selects postoperative patients with pathologically confirmed recurrent glioblastoma
  • KPS score ≥60;
  • Partial or complete tumor resection, Ommaya reservoir has been placed in the operation area, and drug administration conditions are available;
  • As assessed by the investigator, the site of injection of the trial drug is expected to be in the supratentorial area;
  • Life expectancy ≥3 months;
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  • Blood routine: WBC≥ 3.0×10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9.0 g/dL;
  • Liver and kidney function: total bilirubin ≤ 1.5 times the upper limit of the normal value; AST and ALT < 2.5 times the upper limit of the normal value; serum creatinine ≤1.5 times the upper limit of the normal value, or creatinine clearance ≥50 ml/min (calculated by Cockcroft/Gault formula);
  • Coagulation function: INR≤1.5 times the upper limit of the normal value, APTT≤1.5 times the upper limit of the normal value;
  • Women of childbearing age had a negative pregnancy test result within 14 days before enrollment. Female subjects and their spouses received effective contraceptives during and within 6 months of treatment;
  • The subjects voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Who cannot join

  • 1.28 days before enrollment, subjects participated in other clinical trial projects.
  • 2.The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28 days before the first use of the test drug.
  • 3.The subjects have received traditional Chinese medicine, modern Chinese medicine preparations and antiviral drugs within 7 days before using the test drug for the first time.
  • 4.Subjects had received radiotherapy to the brain 3 months before their first use of the test drug.
  • 5.Subjects with other active extracranial malignancies requiring concomitant therapy.
  • 6.Subjects known to be allergic to the test drug or its active ingredients, excipients, and imaging contrast agents.
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  • 7.Subjects who are going to undergo or have received tissue/organ transplantation in the past.
  • 8.The subject has active infection or unexplained fever >38.5℃ during the screening period and before the first dose.
  • 9.Subjects with active pulmonary tuberculosis (TB) who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before screening.
  • 10.Anti-HIV(+) or anti-HCV(+) or specific antibody (TPHA) positive or active hepatitis B (hepatitis B subjects who meet the following criteria are also eligible for inclusion: a) HBV viral load before the first dose The amount must be less than 1000 copies/ml (200 IU/ml), and subjects should receive anti-HBV treatment throughout the trial drug treatment period to avoid viral reactivation; b) For anti-HBc (+), HBsAg (-), anti-HBs ( -) and viral load (-) subjects, do not require prophylactic anti-HBV therapy, but require close monitoring for viral reactivation.
  • 11.Cardiovascular disease meets any of the following: a. Congestive heart failure with cardiac function ≥ NYHA class III; b. Serious arrhythmia requiring drug treatment; c. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass, or stenting occurred within 6 months before the first administration; d. Left ventricular ejection fraction (EF) < 60%; e. QTcF interval > 450 ms in men, > 470 ms in women, or risk factors for torsades de pointes such as clinically significant hypokalemia, family history of long QT syndrome, or family history as judged by the investigator History of arrhythmias (eg, pre-excitation syndrome); f. Uncontrolled hypertension (defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg after standardized antihypertensive drug treatment).
  • 12.Subjects with active autoimmune disease or a history of autoimmune disease but may relapse, but subjects with the following diseases are not excluded and can be further screened: a. Type 1 diabetes; b. Hypothyroidism (if controllable with hormone replacement therapy alone); c. controlled celiac disease; d. Skin diseases that do not require systemic treatment (eg vitiligo, psoriasis, alopecia); e. Any other disease that will not recur in the absence of external triggers.
  • 13.Subjects with unstable mental illness, alcohol, drug or substance abuse. 14. Female subjects who are pregnant or breastfeeding, or who are expected to become pregnant during the trial period (from the screening visit until 180 days after dosing) and male subjects who are expected to conceive their partner.
  • 15. The adverse reactions of previous anti-tumor therapy have not recovered to (CTCAE 5.0) grade 1 (except for alopecia).
  • 16. The investigator determines that he has a serious uncontrollable disease, or there are other conditions that may affect the acceptance of the treatment in this study, and are considered unsuitable to participate in this researcher.
  • 17. Other investigators deem it unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

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

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.

Being tested
OH2 injection
Keywords
Oncolytic Virus
Medical subject headings
Central Nervous System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OH2 injectionBiological

    OH2: Oncolytic Type 2 Herpes Simplex Virus

Study groups in NCT05235074
Study groupRoleWhat they receive
Dose escalation and dose expansionExperimentalThe dose-escalating phase of the phase I trial of OH2 injection is divided into two dose groups (10^6 CCID50/mL and 10^7 CCID50/mL).It will be administered by Ommaya reservoir injection, and the total amount of each dose in each dose group should not exceed 2ml according to the size of the tumor cavity.
Receives: Biological: OH2 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD (Maximum Tolerance dose)

    If ≥2/6 subjects developed DLT, the previous dose group was MTD

    Measured: 2 years

  2. DLTs (Dose Limiting Toxicity)

    Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 3 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol

    Measured: 3 weeks from the first administration

  3. Incidence of AE (Adverse Event) and SAE (Serious Adverse Event)

    All events with a Grade 3 or above toxicity (defined by the CTCAE v5.0) will be tabulated by event and by relationship to OH2.

    Measured: 2 years

Secondary outcomes (4)

  1. OS (Overall Survival)

    The overall survival for each patient receiving OH2 will be calculated.

    Measured: 2 years

  2. PFS (Progression Free Survival)

    Time after OH2 administration to clinical and radiographic disease progression will be evaluated.

    Measured: 2 years

  3. Biodistribution and viral shedding

    OH2 DNA copy

    Measured: 2 years

  4. Immunogenicity

    HSV-2 antibody

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study start16 Nov 2021
  3. Primary completion23 Jul 2026
  4. Study completion23 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05235074
Sponsor's protocol ID
BH-OH2-015
Status last verified
Aug 2026
First submitted
27 Jan 2022
Last updated
5 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zheng Y, Wang X, Ji Q, Fang A, Song L, Xu X, Lin Y, Peng Y, Yu J, Xie L, Chen F, Li X, Zhu S, Zhang B, Zhou L, Yu C, Wang Y, Wang L, Hu H, Zhang Z, Liu B, Wu Z, Li W. OH2 oncolytic virus: A novel approach to glioblastoma intervention through direct targeting of tumor cells and augmentation of anti-tumor immune responses. Cancer Lett. 2024 May 1;589:216834. doi: 10.1016/j.canlet.2024.216834. Epub 2024 Mar 25.

    PubMed 38537773

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OH2 injection in people with Central Nervous System Tumors, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (Maximum Tolerance dose) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05235074, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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