Clinical Study of Oncolytic Virus in Glioblastoma

Korábbi kezelés

• Participated in other drug clinical trials within 4 weeks
• Uncontrolled active infection, unstable or severe concomitant disease of infection. Patients with immunodeficiency, autoimmune diseases, active HBV infection, HCV infection, or active HIV infection.
• Subjects are receiving immunosuppressive therapy, or concurrent chemotherapy, or radiation, or biotherapy.
• There are prohibited items for MRI, such as: pacemakers, epicardial pacemaker wires, infusion pumps, surgical and/or aneurysm clips, shrapnel, metal prostheses, potentially magnetic implants, metal objects in the eye, etc..
• Vaccination within 30 days prior to administration.
• Patients who have received gene transfer therapy or treated with any type of oncolytic virus.
• In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's ability to complete the study.

Más betegség

• Preoperative bleeding susceptibility or use of anticoagulants or any medication that may increase the risk of bleeding.
• Patients with a history of psychotropic substance abuse who are unable to quit or with mental disorders.
• Subjects had any active autoimmune disease or a history of autoimmune disease.
• Has a history of antiviral drug use within 1 week.
• History of substance abuse or known medical, or psychological, or social conditions, such as alcohol or drug abuse.
• Allergic, hypersensitive or intolerant to study oncolytic viruses (including any excipients).
• History of encephalitis, or multiple sclerosis, or other central nervous system (CNS) infections, or primary CNS disease.

Laborértékek

• Have poorly controlled clinical diseases, such as liver aminotransferase (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin > 2 times the upper normal limit.

Egyéb

• Incompatibility of patients with the inclusion criteria mentioned above.
• Patients with extracranial metastases.
• Female subjects: during pregnancy or lactation.
• Male or female patients who refused contraception during the study period and for 6 months after dosing.

• Patients with recurrent glioblastoma, for whom the standard methods of treatment are considered ineffective by the medical commission.
• Histologically confirmed recurrent glioblastoma.
• Magnetic resonance imaging (MRI) showed that the maximum diameter of recurrent lesions is greater than 1.0 cm.
• Before inclusion of patients in the study, at least one of the following types of therapy was previously performed: 4.1 Time from the last radiotherapy/surgery is more than 28 days; 4.2 Subjects maintained stable or declining for at least 7 days prior to corticosteroid regimen; 4.3 Most recent antitumor therapy must have been completed within the specified time prior to treatment: vincristine 2 weeks, nitrosoureas 4 weeks, bevacizumab 4 weeks, temozolomide 6 weeks.
• Age >=18 years, <=70 years.
• Hematological indicators, kidney and liver function are normal.
• The subjects must agree to the use of an acceptable contraceptive method throughout the study, from the time informed consent is provided to 180 days after receiving treatment.
• Patient's ability to perform the study procedure and provide written informed consent in accordance with the GCP and local laws.