drugset / Trial / NCT06562621

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

NCT06562621

Phase 1/2 Completed 38 enrolled Beijing Neurosurgical Institute
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-08-01
Primary completion
2022-08-01
Completion
2024-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cretostimogene Grenadenorepvec Unknown 1 ml Other
Background Flucytosine Small molecule 100 mg/kg Oral

Indications