Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
NCT06585527 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-10-31
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
- Glioblastoma Multiforme
- Glioma, Malignant
Interventions
- 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.
Sponsors & Collaborators
-
Beijing Neurosurgical Institute
lead OTHER
Principal Investigators
-
Fusheng Liu, MD,PhD · Beijing Tiantan Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-29
- Primary Completion
- 2026-01-01
- Completion
- 2026-01-01
Countries
- China
Study Locations
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