Recurrent glioblastoma
Conditions
Interventions
Test group:NRG-103 Injection
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old, regardless of gender; 2.Previous histopathology meets the diagnostic criteria of WHO (2021) for glioblastoma; 3.Patients who have experienced recurrence after previous anti-tumor treatments such as surgery and/or chemotherapy (recurrence criteria refer to RANO 2.0) and meet one of the following two conditions: i The tumor has been surgically removed and an Ommaya sac has been placed inside the tumor cavity; Ii. If the tumor is not suitable or the patient refuses surgical resection, or if there are still residual lesions after surgery, the lesion can be measured (with two maximum vertical diameters of 1.0-5.0 cm, or >=2 times the layer thickness), and the researcher determines that the tumor site is suitable (including but not limited to stereotactic surgery) for the placement of Ommaya cysts inside the tumor; 4.At the time of enrollment, the relevant adverse reactions from the previous treatment have been restored to =70 and expected survival >=3 months, if there is limb hemiplegia caused by tumor resection, an acceptable score of >= 50 is acceptable; 6.Those who have stable or decreased steroid hormone dosage within one week before the first administration of NRG-103 injection; 7.White blood cell count>2.0 × 109/L, neutrophil count>1.0 × 109/L, platelet count>100 × 109/L, international normalized ratio (INR) <=1.5 times ULN, and activated partial thromboplastin time (APTT) <=1.5 times ULN; 8.Individuals whose important organ functions are generally normal, or who have mild abnormalities but are deemed clinically insignificant by the researchers, and whose participation in this study does not increase their risk; 9.Men and women of childbearing age should agree to take effective non pharmacological contraceptive measures from the time of signing the informed consent form until 6 months after the last dose; 10.Patients voluntarily participate in the study, sign informed consent forms, have good compliance, and are able to cooperate with follow-up visits;
Exclusion criteria
Exclusion criteria: 1.Known or suspected allergy to the components of the test drug and contrast agent; 2.Those who are unable or unwilling to undergo imaging examinations required for the research; 3.Individuals with a history of cell therapy, gene therapy, or oncolytic virus therapy; 4.Those who are currently using other investigational drugs; 5.Patients who have received anti-tumor vaccines or other immunomodulatory drugs (such as interferon, interleukin-2, thymosin, shiitake mushroom polysaccharides, etc.) within 4 weeks before their first medication; Patients who have received or will receive attenuated live or recombinant vaccines within 4 weeks prior to their first medication; Individuals who have received or will receive inactivated vaccines within one week prior to their first medication; 6.Those who have had other malignant tumors within the past 3 years or at the same time; 7.Patients with co infection requiring intravenous medication treatment or unexplained fever (body temperature = 37.5 ?); 8.Individuals with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism); 9.History of immunodeficiency (HIV antibody test positive), or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 10.Active hepatitis B (HBV DNA >=500 IU/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method) or patients with co infection of hepatitis B and hepatitis C; 11.People with unstable or serious other diseases, such as severe heart disease (NYHA III or IV), or poorly controlled diabetes; 12.Patients with two or more GBM lesions in the skull; 13.Patients with tumor lesions in the brainstem, cerebellum, posterior fossa, or spinal cord, as well as leptomeningeal diseases; 14.Patients with diffuse subarachnoid and subarachnoid diseases; 15.Head MRI suggests tumor enhancement with marginal invasion of the ventricular wall or tumor cavity communicating with the ventricle after surgery; 16.Individuals with a history of encephalitis, multiple sclerosis, or other central nervous system infections; 17.Patients with cerebral herniation syndrome; 18.Pregnant and lactating women; 19.Other situations that the researcher deems unsuitable for entry into the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To preliminarily evaluate the safety and tolerability of NRG-103 in the treatment of relapsed GBM; | — |
Countries
China
Contacts
Public ContactZhiqiang Li
Zhongnan Hospital of Wuhan University
Outcome results
None listed