Evaluating TS-2021 for treating recurrent malignant glioma
A Clinical Study of the Safety and Efficacy of Third-generation Oncolytic TS-2021 in the Treatment of Recurrent Malignant Gliomas
This study is testing a new virus treatment called TS-2021 to see if it can help people with recurrent malignant glioma feel better and improve their condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Neurosurgical Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06585527 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of the oncolytic virus TS-2021 in patients with recurrent malignant glioma. Approximately 30 eligible participants will receive intratumoral injections of TS-2021 and will be monitored for one year to evaluate treatment outcomes. Follow-up will include imaging studies, neurological function tests, and reporting of any adverse events. The data collected will be analyzed statistically to determine the effectiveness of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of recurrent high-grade glioma and specific imaging criteria.
Not a fit: Patients with tumors that do not meet the specified imaging criteria or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent malignant glioma.
How similar studies have performed: While the use of oncolytic viruses is a novel approach, similar studies have shown promise in treating other types of cancers, indicating potential for success.
Eligibility criteria
Show full 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Fusheng Liu, MD,PhD
- Email: liufushengs@hotmail.com
- Phone: 861059975630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.