Glioblastoma (GBM)Phase 1/2NCT07145047
Clinical Study of Oncolytic Virus in Glioblastoma
A Phase 1/2 study testing oncolytic virus in people with Glioblastoma (GBM), run by Mianyang Central Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate whether an oncolytic viral agent can treat recurrent glioblastoma. It will also assess the safety and tolerability of the oncolytic viral agent. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- oncolytic virus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2023to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with recurrent glioblastoma, for whom the standard methods of treatment are considered ineffective by the medical commission.
- Histologically confirmed recurrent glioblastoma.
- Magnetic resonance imaging (MRI) showed that the maximum diameter of recurrent lesions is greater than 1.0 cm.
- Before inclusion of patients in the study, at least one of the following types of therapy was previously performed: 4.1 Time from the last radiotherapy/surgery is more than 28 days; 4.2 Subjects maintained stable or declining for at least 7 days prior to corticosteroid regimen; 4.3 Most recent antitumor therapy must have been completed within the specified time prior to treatment: vincristine 2 weeks, nitrosoureas 4 weeks, bevacizumab 4 weeks, temozolomide 6 weeks.
- Age >=18 years, <=70 years.
- Hematological indicators, kidney and liver function are normal.
- The subjects must agree to the use of an acceptable contraceptive method throughout the study, from the time informed consent is provided to 180 days after receiving treatment.
- Patient's ability to perform the study procedure and provide written informed consent in accordance with the GCP and local laws.
Who cannot join
- Incompatibility of patients with the inclusion criteria mentioned above.
- Participated in other drug clinical trials within 4 weeks
- Preoperative bleeding susceptibility or use of anticoagulants or any medication that may increase the risk of bleeding.
- Patients with extracranial metastases.
- Have poorly controlled clinical diseases, such as liver aminotransferase (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin > 2 times the upper normal limit.
- Female subjects: during pregnancy or lactation.
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- Uncontrolled active infection, unstable or severe concomitant disease of infection. Patients with immunodeficiency, autoimmune diseases, active HBV infection, HCV infection, or active HIV infection.
- Patients with a history of psychotropic substance abuse who are unable to quit or with mental disorders.
- Subjects had any active autoimmune disease or a history of autoimmune disease.
- Has a history of antiviral drug use within 1 week.
- Subjects are receiving immunosuppressive therapy, or concurrent chemotherapy, or radiation, or biotherapy.
- There are prohibited items for MRI, such as: pacemakers, epicardial pacemaker wires, infusion pumps, surgical and/or aneurysm clips, shrapnel, metal prostheses, potentially magnetic implants, metal objects in the eye, etc..
- History of substance abuse or known medical, or psychological, or social conditions, such as alcohol or drug abuse.
- Allergic, hypersensitive or intolerant to study oncolytic viruses (including any excipients).
- Vaccination within 30 days prior to administration.
- Patients who have received gene transfer therapy or treated with any type of oncolytic virus.
- History of encephalitis, or multiple sclerosis, or other central nervous system (CNS) infections, or primary CNS disease.
- Male or female patients who refused contraception during the study period and for 6 months after dosing.
- In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's ability to complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621000
Hong yuan Liu, +868162247827, lhy@sc-mch.cn
About this study
Official title: Clinical Study on the Application of Oncolytic Virus in Recurrent Glioblastoma
This clinical trial aims to evaluate whether an oncolytic viral agent can treat recurrent glioblastoma. It will also assess the safety and tolerability of the oncolytic viral agent. The primary question it seeks to answer is: What medical problems do participants experience when injected with the oncolytic viral agent? Researchers will administer the oncolytic viral agent via intratumoral injection to determine its efficacy in treating recurrent glioblastoma.
Participant Procedures:
Read more
Receive the initial injection, followed by additional injections every 2-4 weeks for a total of 6 injections.
Undergo physical examinations and tests every 2 to 4 weeks. Record their symptoms, hematological test results, and imaging findings.
- Conditions
- Glioblastoma (GBM)
- Being tested
- oncolytic virus
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oncolytic virusBiological
Intratumoral injection of oncolytic virus.
| Study group | Role | What they receive |
|---|---|---|
| oncolytic virus in recurrent glioblastoma | Experimental | Not described Receives: Biological: oncolytic virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: 4 hours, 2 days, 7 days and 14 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start2 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mianyang Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liangxue Zhou, Mianyang Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145047
- Sponsor's protocol ID
- S20230381-02
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Application of Oncolytic Virus in Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT07145047
- Acronym / sponsor ID
- S20230381-02
- Conditions
- Glioblastoma (GBM)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mianyang Central HospitalUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to evaluate whether an oncolytic viral agent can treat recurrent glioblastoma. It will also assess the safety and tolerability of the oncolytic viral agent. The primary question it seeks to answer is: What medical problems do participants experience when injected with the oncolytic viral agent? Researchers will administer the oncolytic viral agent via intratumoral injection to determine its efficacy in treating recurrent glioblastoma.
Participant Procedures:
Receive the initial injection, followed by additional injections every 2-4 weeks for a total of 6 injections.
Undergo physical examinations and tests every 2 to 4 weeks. Record their symptoms, hematological test results, and imaging findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oncolytic virus in recurrent glioblastoma | Experimental | Biological: oncolytic virus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with recurrent glioblastoma, for whom the standard methods of treatment are considered ineffective by the medical commission.
- Histologically confirmed recurrent glioblastoma.
- Magnetic resonance imaging (MRI) showed that the maximum diameter of recurrent lesions is greater than 1.0 cm.
- Before inclusion of patients in the study, at least one of the following types of therapy was previously performed: 4.1 Time from the last radiotherapy/surgery is more than 28 days; 4.2 Subjects maintained stable or declining for at least 7 days prior to corticosteroid regimen; 4.3 Most recent antitumor therapy must have been completed within the specified time prior to treatment: vincristine 2 weeks, nitrosoureas 4 weeks, bevacizumab 4 weeks, temozolomide 6 weeks.
- Age >=18 years, <=70 years.
Key exclusion criteria (19 listed)
- Incompatibility of patients with the inclusion criteria mentioned above.
- Participated in other drug clinical trials within 4 weeks
- Preoperative bleeding susceptibility or use of anticoagulants or any medication that may increase the risk of bleeding.
- Patients with extracranial metastases.
- Have poorly controlled clinical diseases, such as liver aminotransferase (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin > 2 times the upper normal limit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oncolytic virusIntratumoral injection of oncolytic virus. | Biological | oncolytic virus in recurrent glioblastoma |
Primary outcome
Maximum tolerated dose
Time frame: 4 hours, 2 days, 7 days and 14 days after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing oncolytic virus in people with Glioblastoma (GBM), run by Mianyang Central Hospital 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 8 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang xue Zhou (+868162247827, liangxue_zhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: 4 hours, 2 days, 7 days and 14 days after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.