NCT06585527 Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
| NCT ID | NCT06585527 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Beijing Neurosurgical Institute |
| Condition | Glioblastoma Multiforme |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-29 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-08-29 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Fusheng Liu, MD,PhD
STUDY DIRECTOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT06585527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Glioblastoma Multiforme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06585527 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06585527 currently recruiting?
Yes, NCT06585527 is actively recruiting participants. Contact the research team at liufushengs@hotmail.com for enrollment information.
Where is the NCT06585527 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06585527 clinical trial?
NCT06585527 is sponsored by Beijing Neurosurgical Institute. The principal investigator is Fusheng Liu, MD,PhD at Beijing Tiantan Hospital. The trial plans to enroll 30 participants.
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