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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Beijing Neurosurgical Institute
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Updated on 9 September 2024
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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.

Details
Condition Glioblastoma Multiforme, Glioma, Malignant
Age 18years - 65years
Clinical Study IdentifierNCT06585527
SponsorBeijing Neurosurgical Institute
Last Modified on9 September 2024

Eligibility

 Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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