Clinical Study of Oncolytic Virus in Glioblastoma

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Clinical Study of Oncolytic Virus in Glioblastoma

Study Purpose

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 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07145047
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mianyang Central Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma (GBM)

Arms & Interventions

Arms

Experimental: oncolytic virus in recurrent glioblastoma

Interventions

Biological: - oncolytic virus

Intratumoral injection of oncolytic virus.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.