Clinical Study of Oncolytic Virus in Glioblastoma

NCT07145047 | Recruiting Phase 1 DMC

• 1 other identifier: S20230381-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma (GBM)

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  4 hours, 2 days, 7 days and 14 days after administration

Study Arms (1)

oncolytic virus in recurrent glioblastoma

EXPERIMENTAL

Biological: oncolytic virus

Interventions

oncolytic virus BIOLOGICAL

Intratumoral injection of oncolytic virus.

oncolytic virus in recurrent glioblastoma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mianyang Central Hospital: lead

Study Sites (1)

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Oncolytic Virotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Liang xue Zhou

CONTACT

+868162247827; liangxue_zhou@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: November 2, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)