NIPH Clinical Trials Search

A phase I clinical trial of a bevacizumab-expressing oncolytic herpesvirus T-BV in patients with malignant glioma

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	malignant glioma
Date of first enrollment	01/12/2025
Target sample size	12
Countries of recruitment
Study type	Interventional
Intervention(s)	T-BV is administered at a dose of 1 billion pfu per injection. A total volume of 1 mL, diluted with saline to a concentration of 1 billion pfu/mL, is slowly injected in divided portions into up to two target sites. Administer the second dose within 5 to 14 days.

Outcome(s)

Primary Outcome	Safety -Spectrum and frequency of adverse events
Secondary Outcome	Efficacy -Overall survival -Progression free survival -Tumor changes on MRI images

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients who have experienced tumor progression or recurrence following standard initial treatment for glioblastoma (IDH-wildtype) or grade 4 astrocytoma (IDH-mutant), and who meet all of the following criteria, will be eligible for inclusion in this study. 1) A confirmed histopathological diagnosis of glioblastoma (IDH-wildtype) or grade 4 astrocytoma (IDH-mutant) based on the WHO 2021 classification is required. 2) Patients who have experienced tumor progression or recurrence following standard initial treatment. 3) Patients with a confirmed lesion measuring >=1.0 cm on magnetic resonance imaging (MRI) performed within 14 days prior to the eligibility assessment date. 4) Patients with a Karnofsky Performance Status (KPS) of >=60% (or >=50% if the reduction is due to surgery-related paralysis). 5) The patient must be at least 18 years old at the time informed consent is obtained. 6) Patients who are capable of providing written informed consent themselves. 7) Maintain a constant steroid dosage for at least one week prior to Eligibility Determination Date. 8) Willing to use effective barrier birth control for at least 6 months after T-BV administration. 9) Expected survival >= 3 months. 10) Laboratory test results meet the following criteria - White blood cell count>2000/mm3, Absolute neutrophil count (ANC)>1000 /mm3, Platelets>100,000 /mm3, Hemoglobin>9.0 g/dL - Prothrombin time-international normalized ratio <= 1.3 times the upper limit of facility reference value - Serum creatinine<1.7mg/dL - AST and ALT <= 4 times the upper limit of facility reference value - Total bilirubin<=1.5 mg/dL
Exclude criteria	1) Patients with a medical history or current condition of any of the following: - A history of encephalitis, multiple sclerosis, or other central nervous system infections - Known HIV seropositivity - Any contraindication for undergoing gadolinium contrast enhanced MRI such as: individuals with pacemakers, infusion pumps, or allergy to MRI contrast media 2) Patients in whom any of the following tumor conditions have been confirmed: - Extracranial metastasis of the tumor - Multiple (two or more) intracranial malignant glioma lesions - Tumors located in the ventricles, brainstem, or posterior fossa, or tumors requiring administration of the investigational drug via the ventricular route - Subependymal and subarachnoid dissemination 3) Patients with any of the following comorbidities: - Active herpesvirus infection - Herpesvirus infection requiring treatment with antiviral agents such as acyclovir, valacyclovir, famciclovir, vidarabine, or amenamevir - Active, uncontrolled infection that would interfere with the performance of surgery - Uncontrolled or severe medical condition such as heart failure, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, and autoimmune disease - History of alcohol or other drug dependency - Other active cancer 4) Allergy to anti-HSV drug 5) Patients who have received any of the following treatments: - Administration of other clinical study drugs or research treatments within 30 days of T-BV administration - Surgical resection of a brain tumor within 30 days of T-BV administration - Bevacizumab within 30 days of T-BV administration -Prior gene therapy or oncolytic virus therapy other than T-BV 6) Pregnant or nursing females 7) Conditions considered inadequate for the subject to be enrolled in the study