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RecruitingNCT07145047Updated Dec 19, 2025

Clinical Study of Oncolytic Virus in Glioblastoma

A Phase 1/2 interventional study of oncolytic virus in Glioblastoma (GBM), sponsored by Mianyang Central Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Mianyang Central Hospital · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 9 months after the study started (first participant enrolled Nov 2023, registered Aug 2025).
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Glioblastoma (GBM)

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03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 20 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Mianyang Central Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with recurrent glioblastoma, for whom the standard methods of treatment are considered ineffective by the medical commission.
  2. Histologically confirmed recurrent glioblastoma.
  3. Magnetic resonance imaging (MRI) showed that the maximum diameter of recurrent lesions is greater than 1.0 cm.
  4. 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.
  5. Age >=18 years, \<=70 years.
  6. Hematological indicators, kidney and liver function are normal.
  7. 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.
  8. Patient's ability to perform the study procedure and provide written informed consent in accordance with the GCP and local laws.

Exclusion criteria

Exclusion criteria:

  1. Incompatibility of patients with the inclusion criteria mentioned above.
  2. Participated in other drug clinical trials within 4 weeks
  3. Preoperative bleeding susceptibility or use of anticoagulants or any medication that may increase the risk of bleeding.
  4. Patients with extracranial metastases.
  5. 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.
  6. Female subjects: during pregnancy or lactation.
  7. Uncontrolled active infection, unstable or severe concomitant disease of infection. Patients with immunodeficiency, autoimmune diseases, active HBV infection, HCV infection, or active HIV infection.
  8. Patients with a history of psychotropic substance abuse who are unable to quit or with mental disorders.
  9. Subjects had any active autoimmune disease or a history of autoimmune disease.
  10. Has a history of antiviral drug use within 1 week.
  11. Subjects are receiving immunosuppressive therapy, or concurrent chemotherapy, or radiation, or biotherapy.
  12. 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..
  13. History of substance abuse or known medical, or psychological, or social conditions, such as alcohol or drug abuse.
  14. Allergic, hypersensitive or intolerant to study oncolytic viruses (including any excipients).
  15. Vaccination within 30 days prior to administration.
  16. Patients who have received gene transfer therapy or treated with any type of oncolytic virus.
  17. History of encephalitis, or multiple sclerosis, or other central nervous system (CNS) infections, or primary CNS disease.
  18. Male or female patients who refused contraception during the study period and for 6 months after dosing.
  19. 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    oncolytic virus in recurrent glioblastoma

    Biological: oncolytic virus

Interventions

  • Biologicaloncolytic virus

    Intratumoral injection of oncolytic virus.

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose

    Time frame: 4 hours, 2 days, 7 days and 14 days after administration

07

Study locations

1 of 1 sites recruiting
  • Mianyang Central Hospital
    Mianyang, Sichuan 621000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07145047
Lead sponsor
Mianyang Central Hospital
Responsible party
Liangxue Zhou (Dr., Mianyang Central Hospital) — Principal investigator
First posted
Aug 28, 2025
Start date
Nov 2, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 19, 2025

Study contacts

Liang xue Zhou
Contact
liangxue_zhou@126.com
+868162247827

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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