Trials / Recruiting
RecruitingNCT06585527
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Beijing Neurosurgical Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TS-2021 | The participants meeting the criteria will undergo TS-2021 oncolytic virus (5×1011PFU/ml) intratumoral injection using stereotactic technique under MR Localization. |
Timeline
- Start date
- 2024-08-29
- Primary completion
- 2026-01-01
- Completion
- 2026-01-01
- First posted
- 2024-09-05
- Last updated
- 2024-10-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06585527. Inclusion in this directory is not an endorsement.