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

Launched by BEIJING NEUROSURGICAL INSTITUTE · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TS-2021, which is an oncolytic virus designed to target and fight recurrent malignant gliomas, a type of brain tumor. The main goal is to see how safe and effective this treatment is for patients who have already undergone surgery and other treatments but have experienced a recurrence of their tumors. About 30 participants aged between 18 and 65 who meet specific health criteria will receive an injection of the TS-2021 virus directly into their tumors. These participants will be monitored for one year to assess their health through imaging tests, neurological evaluations, and to track any side effects.

To be eligible for this trial, participants must have a confirmed diagnosis of a specific type of high-grade glioma and show evidence of tumor recurrence, among other health requirements. They should be in relatively good health, with certain blood test results meeting established standards. Participants can expect to have regular check-ups and tests throughout the year, helping researchers gather important data on how the virus works in the body. It’s important to note that individuals who are pregnant, breastfeeding, or have certain health conditions will not be able to participate in this study. Overall, this trial represents a potential new approach to treating challenging brain tumors, and participants will play a crucial role in advancing our understanding of this treatment.

Gender

ALL

Eligibility 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.