Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients

Prior treatment

• GBM lesion invades the ventricular wall or tumor cavity communicates with the ventricle after surgery.

Other illness

• Allergy to the components of the test drug and contrast agent.
• A history of cell therapy, gene therapy, or oncolytic virus therapy.
• A history of anti-tumor vaccines or other immunomodulatory drugs with 4 weeks.
• A history of other type of malignant tumors.
• A history of autoimmune disease.
• A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
• Active hepatitis B, or hepatitis C.
• Severe heart disease (NYHA III or IV), or poorly controlled diabetes.
• GBM lesion located in the brainstem, cerebellum, posterior fossa, or spinal cord, as well as leptomeningeal diseases.
• A history of diffuse subarachnoid and subarachnoid diseases.
• A history of encephalitis, multiple sclerosis, or other central nervous system infections.
• Cerebral herniation syndrome.

Other

• Unable to undergo imaging examinations required for the research.
• Undergoing other clinical trials.
• Unexplained fever.
• Two or more GBM lesions.
• Pregnant and lactating women.
• Other situations that the researcher deems unsuitable for entry into the study.

• Age≥18 years.
• Patients must have histologically or cytologically confirmed glioblastoma(WHO 2021).
• Patients have experienced recurrence (RANO 2.0) after previous anti-tumor treatments, including the recurrent tumor has been surgically removed and an Ommaya reservoir has been placed inside the tumor cavity.
• The relevant adverse reactions from the previous treatment have been restored to ≤1 level(NCI-CTCAE v5.0).
• Karnofsky Performance Score≥70.
• Stable doses of dexamethasone during the week prior to inclusion.
• Adequate bone marrow reserve: White blood cell count\>2.0 × 109/L, neutrophil count\>1.0 × 109/L, platelet count\>100 × 109/L, international normalized ratio ≤1.5 times ULN, and activated partial thromboplastin time≤1.5 times ULN.
• Normal heart, renal and liver function.
• Effective method of contraception for patients and their partners.
• Written informed consent.