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Trial Title:
Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
NCT ID:
NCT06585527
Condition:
Glioblastoma Multiforme
Glioma, Malignant
Conditions: Official terms:
Glioblastoma
Glioma
Conditions: Keywords:
Oncolytic Virus
Adenovirus
Glioblastoma Multiforme
Glioma, Malignant
Ki-67
TGF-β2
IL-15
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
TS-2021
Description:
The participants meeting the criteria will undergo TS-2021 oncolytic virus (5×1011PFU/ml)
intratumoral injection using stereotactic technique under MR Localization.
Arm group label:
TS-2021
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tiantan Hospital
Address:
City:
Beijing
Zip:
100050
Country:
China
Status:
Recruiting
Contact:
Last name:
Fusheng Liu, MD,PhD
Phone:
861059975630
Email:
liufushengs@hotmail.com
Contact backup:
Last name:
Junwen Zhang, PhD
Phone:
861059975630
Email:
jewzhang@hotmail.com
Start date:
August 29, 2024
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Beijing Neurosurgical Institute
Agency class:
Other
Source:
Beijing Neurosurgical Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06585527
