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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06585527
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Neurosurgical Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Fusheng Liu, MD,PhD
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme, Glioma, Malignant

Arms & Interventions

Arms

Experimental: TS-2021

30 eligible participants with recurrent malignant glioma will be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.