Clinical trial NCT06562621: Clinical Study on the Safety and Efficacy of Novel Oncolytic Virus in the Treatment of Recurrent Malignant Glioma
Official title: Clinical Study on the Safety and Efficacy of Novel Oncolytic Virus in the Treatment of Recurrent Malignant Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme
Gliomas, Malignant
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Glioma is the most common intracranial tumor. Among them, malignant glioma shows diffuse and infiltrating growth. Although it is given a comprehensive treatment such as surgery, radiotherapy and chemotherapy, it is prone to relapse, and there is an urgent need to explore new treatment methods. Oncolytic virus is currently the world's most cutting-edge treatment of glioma. On the basis of previous research on glioma and oncolytic virus (HSV-1), an engineered new oncolytic virus ON-01 containing CD gene has been constructed. In vitro and in vivo animal experiments have found that it has a good therapeutic effect on malignant glioma, and it has been approved by the ethics committee of Tiantan Hospital for its clinical research. This project intends to study the safety and effectiveness of ON-01 in the clinic on the basis of pre-clinical trials and preclinical research, clarify the oncolytic mechanism of ON-01 in the treatment of malignant glioma, and explore the dissolution of brain glioma. The new strategy of tumor virus treatment lays a theoretical foundation for the clinical promotion and application of ON-01 and product transformation.


Eligibility criteria: Inclusion Criteria:

1. Patients has given written informed consent；
2. Age is between 18 years old and 75 years old, inclusive;
3. Patients must have histologically or cytologically confirmed Glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendrocyte-glioma;
4. Residual lesion must be ≥1.0 cm in diameter as determined by MRI;
5. Karnofsky Performance Status ≥70%;
6. Patients must have normal organ and marrow function. Absolute neutrophil count: ≥ 1,500/mm3, Hemoglobin\>10 g/dL platelets: \>100,000/mm3, total bilirubin\< 1.5 ×ULN; AST(SGOT)(aspartate aminotransferase)/ALT(SGPT)(alanine aminotransferase): \<2.5 X institutional upper limit of normal; Serum creatinine \< 1.5 ×ULN, and normal heart function;
7. Good compliance: can actively cooperate with doctors' treatment and follow-up survey;
8. Females of childbearing potential must not be pregnant; this will be confirmed by a negative serum pregnancy test within 7 days prior to starting study treatment and must use a birth control method in addition to barrier methods (condoms).

Exclusion Criteria:

1. Pregnant or lactating women;
2. Prior history of encephalitis, multiple sclerosis, or other CNS infection;
3. Herpes simplex virus infection active period;
4. Patients with a history of organ transplantation or waiting for an organ transplant;
5. Uncontrollable infectious diseases or other serious diseases such as HIV positive;
6. Severe pulmonary, cardiac or other systemic disease, specifically: Including active infections, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that began to develop within the last 3 months, congestive heart failure, myocardial infarction that occurred within the first 12 months of enrollment, requiring serious;medical treatment Arrhythmia, liver, kidney failure, etc.;
7. Patients with systemic autoimmune disease or immunodeficiency disease;
8. Patients with severe allergies;
9. Patients with chronic diseases requiring long-term immunologic preparation or glucocorticoid therapy.

Primary outcomes:
measure: Long term safety follow up
timeFrame: From study entry up to 5 years
Secondary outcomes:
measure: Overall survival in days from the initial ON-01 administration on parent study to the date of death.
timeFrame: From initial ON-01 administration to death of last patient alive for up to 5 years.
measure: Progression-free survival in days from the initial ON-01 administration on parent study to confirmed disease progression or death from any cause.
timeFrame: from initial ON-01 administration to time of progression or death of any cause for up to 5 years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: