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Tests treatment safety and results for Glioblastoma Multiforme
Official title Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
ClinicalTrials.gov ID: NCT06585527
What this study is testing
What is TS-2021?
TS-2021 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- After conventional surgery, radiotherapy (or) chemotherapy was performed, and there was no recurrence at the primary site of the tumor, but there was...
- With PET/MRS, tumor recurrence was considered, and the enhanced lesion diameter was greater than 1cm, but less than 3cm.
You likely can't join if
- 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...
- Patients with systemic autoimmune diseases or immunodeficiency diseases.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.