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Clinical Study on the Safety and Efficacy of Novel Oncolytic Virus in the Treatment of Recurrent Malignant Glioma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Clinical Study on the Safety and Efficacy of Novel Oncolytic Virus in the Treatment of Recurrent Malignant Glioma

NCT06562621•Beijing Neurosurgical Institute

View on ClinicalTrials.gov

Summary

Glioma is the most common intracranial tumor. Among them, malignant glioma shows diffuse and infiltrating growth. Although it is given a comprehensive treatment such as surgery, radiotherapy and chemotherapy, it is prone to relapse, and there is an urgent need to explore new treatment methods. Oncolytic virus is currently the world's most cutting-edge treatment of glioma. On the basis of previous research on glioma and oncolytic virus (HSV-1), an engineered new oncolytic virus ON-01 containing CD gene has been constructed. In vitro and in vivo animal experiments have found that it has a good therapeutic effect on malignant glioma, and it has been approved by the ethics committee of Tiantan Hospital for its clinical research. This project intends to study the safety and effectiveness of ON-01 in the clinic on the basis of pre-clinical trials and preclinical research, clarify the oncolytic mechanism of ON-01 in the treatment of malignant glioma, and explore the dissolution of brain glioma. The new strategy of tumor virus treatment lays a theoretical foundation for the clinical promotion and application of ON-01 and product transformation.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients has given written informed consent；
•2. Age is between 18 years old and 75 years old, inclusive;
•3. Patients must have histologically or cytologically confirmed Glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendrocyte-glioma;
•4. Residual lesion must be ≥1.0 cm in diameter as determined by MRI;
•5. Karnofsky Performance Status ≥70%;
•6. Patients must have normal organ and marrow function. Absolute neutrophil count: ≥ 1,500/mm3, Hemoglobin\>10 g/dL platelets: \>100,000/mm3, total bilirubin\< 1.5 ×ULN; AST(SGOT)(aspartate aminotransferase)/ALT(SGPT)(alanine aminotransferase): \<2.5 X institutional upper limit of normal; Serum creatinine \< 1.5 ×ULN, and normal heart function;
•7. Good compliance: can actively cooperate with doctors' treatment and follow-up survey;
•8. Females of childbearing potential must not be pregnant; this will be confirmed by a negative serum pregnancy test within 7 days prior to starting study treatment and must use a birth control method in addition to barrier methods (condoms).

Exclusion Criteria

•1. Pregnant or lactating women;
•2. Prior history of encephalitis, multiple sclerosis, or other CNS infection;
•3. Herpes simplex virus infection active period;
•4. Patients with a history of organ transplantation or waiting for an organ transplant;
•5. Uncontrollable infectious diseases or other serious diseases such as HIV positive;
•6. Severe pulmonary, cardiac or other systemic disease, specifically: Including active infections, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that began to develop within the last 3 months, congestive heart failure, myocardial infarction that occurred within the first 12 months of enrollment, requiring serious;medical treatment Arrhythmia, liver, kidney failure, etc.;
•7. Patients with systemic autoimmune disease or immunodeficiency disease;
•8. Patients with severe allergies;
•9. Patients with chronic diseases requiring long-term immunologic preparation or glucocorticoid therapy.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 1, 2018

Primary Completion Date

August 1, 2022

Completion Date

March 1, 2024

Last Updated

August 20, 2024

Enrollment

ACTUAL participants

Conditions

Glioblastoma MultiformeGliomas, Malignant

Interventions

ON-01

BIOLOGICAL

ONF

DRUG

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study on the Safety and Efficacy of Novel Oncolytic Virus in the Treatment of Recurrent Malignant Glioma

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Targeted Pediatric High-Grade Glioma Therapy

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