RecruitingPhase 1NCT06585527

Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma

A Clinical Study of the Safety and Efficacy of Third-generation Oncolytic TS-2021 in the Treatment of Recurrent Malignant Gliomas


Sponsor

Beijing Neurosurgical Institute

Enrollment

30 participants

Start Date

Aug 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of oncolytic virus TS-2021 in the treatment of recurrent malignant glioma.About 30 eligible participants with recurrent malignant glioma will : * Be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy. * Be followed for 1 year after the injection to complete imaging studies, neurological function tests, and report adverse events. Using the data obtained during the follow-up period, researchers will conduct statistical analyses and evaluate the safety and efficacy of oncolytic virus TS-2021.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called TS-2021 for people with recurrent high-grade glioma (a fast-growing, aggressive brain tumor) that has come back after standard treatment. The trial is designed to assess both the safety and effectiveness of this new therapy. **You may be eligible if...** - You are between 18 and 65 years old - You had a brain tumor (supratentorial high-grade glioma) that was completely removed surgically, followed by standard radiation and/or chemotherapy - Your tumor did not show recurrence within 2 months after radiotherapy, but has now recurred - Your overall health is rated 0–2 on standard performance scales - Your major organ functions are within acceptable ranges **You may NOT be eligible if...** - Your tumor is located in the brainstem or cerebellum - You have had more than one recurrence - You are pregnant or breastfeeding - You have severe heart, liver, or kidney conditions - You have active uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTS-2021

The participants meeting the criteria will undergo TS-2021 oncolytic virus (5×1011PFU/ml) intratumoral injection using stereotactic technique under MR Localization.


Locations(1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

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NCT06585527


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