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

RECRUITINGPHASE1

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

NCT06585527•Beijing Neurosurgical Institute

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient signed the informed consent voluntarily.
•Age ≥18 years and ≤65 years, male or female.
•After the initial surgery, the imaging showed that the tumor was completely removed, followed by conventional radiotherapy or (and) chemotherapy, and no recurrence was observed within two months after the end of radiotherapy. The patient had a recurrence of supratentorial high-grade glioma. The pathological diagnosis was glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendro-astrocytoma, or subtentorial astrocytoma recurrence.
•After conventional surgery, radiotherapy (or) chemotherapy was performed, and there was no recurrence at the primary site of the tumor, but there was tumor recurrence at the distant site.
•With PET/MRS, tumor recurrence was considered, and the enhanced lesion diameter was greater than 1cm, but less than 3cm.
•KPS score ≥70 before treatment.
•Normal bone marrow reserve function and normal liver and kidney function: Neutrophil absolute value ≥ 1,500/mm3, hemoglobin ≥10 g/dL, platelet count ≥100,000/mm3, total bilirubin level ≤1.5×ULN, glutamic pyruvic transaminase/glutamic oxalacetic transaminase ≤ 2.5× ULN, serum creatinine ≤1.5×ULN, The heart function was normal and the follow-up compliance was good.
•Women of childbearing age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure that they do not become pregnant during the study period and for 3 months after stopping treatment.

Exclusion Criteria

•Pregnant or lactating patients.
•Patients with encephalitis disease, multiple sclerosis, or other CNS (Central Nervous System) infection.
•Patients with a history of organ transplantation or waiting for organ transplantation.
•Patients with uncontrolled infectious diseases or other serious diseases, such as HIV positive.
•Patients with any unstable systemic illness (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 12 months before enrollment, severe arrhythmia requiring medical treatment, liver or kidney failure, etc.)
•Patients with systemic autoimmune diseases or immunodeficiency diseases.
•Patients with severe allergic constitution.
•Patients with chronic diseases requiring long-term treatment with immune agents or glucocorticoids.
•Patients with mental disorders.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 29, 2024

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

October 31, 2024

Enrollment

ESTIMATED participants

Conditions

Glioblastoma MultiformeGlioma, Malignant

Interventions

TS-2021

BIOLOGICAL

Contacts

Fusheng Liu, MD,PhD

CONTACT

861059975630 liufushengs@hotmail.com

Junwen Zhang, PhD

CONTACT

861059975630 jewzhang@hotmail.com

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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: October 31, 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 TS-2021 in the Treatment of Recurrent Malignant Glioma

Inclusion Criteria

Exclusion Criteria

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