Injected oncolytic virus for recurrent glioblastoma

Clinical Study on the Application of Oncolytic Virus in Recurrent Glioblastoma

This trial tries an injected oncolytic virus to see if it can shrink or control recurrent glioblastoma in adults.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Mianyang Central Hospital (Academic / other)
• Drugs / interventions: bevacizumab, chemotherapy, radiation
• Locations: 1 site (Mianyang, Sichuan)
• Trial ID: NCT07145047 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional study gives an oncolytic viral agent directly into recurrent glioblastoma tumors via intratumoral injection, with up to six injections spaced every 2–4 weeks. Participants will have regular physical exams, blood tests, and brain imaging every 2–4 weeks to monitor safety, tolerability, and any tumor response. Eligible patients are adults (18–70) with histologically confirmed recurrent GBM and lesions larger than 1.0 cm who have exhausted standard treatment options and have adequate organ function. The trial is conducted at a single center (Mianyang Central Hospital) and focuses primarily on safety while collecting preliminary efficacy data.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed recurrent glioblastoma, a recurrent lesion >1.0 cm, prior standard therapies completed per protocol time windows, and normal hematologic, liver, and kidney function are ideal candidates.

Not a fit: Patients outside the age range, with poor organ function, very small lesions, active uncontrolled illness, or who cannot stop conflicting therapies or travel to the study site may not receive benefit from participation.

Why it matters

Potential benefit: If successful, the approach could shrink tumors or slow progression and offer a new treatment option for people with recurrent GBM.

How similar studies have performed: Early-phase trials of other oncolytic viruses in glioblastoma have demonstrated acceptable safety and occasional tumor responses, but no definitive, widely adopted curative benefit yet.

Eligibility criteria

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:

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.

Where this trial is running

Mianyang, Sichuan

• Mianyang Central Hospital — Mianyang, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Liang xue Zhou

Conditions Glioblastoma