Tests NRG-103 injection in adults with recurring glioblastoma brain cancer
Tests NRG-103 injection for safety and effect in adults with returning glioblastoma.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose glioblastoma has come back after earlier treatment. The returned tumor must have been removed by surgery, with an Ommaya reservoir placed in the tumor cavity.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Glioblastoma (WHO 2021) confirmed by tissue or cell tests. The tumor has recurred (RANO 2.0). Only one lesion, and not in the brainstem, cerebellum, posterior fossa or spinal cord.
- Earlier treatment
- Must have had earlier anti-tumor treatment. Side effects from it must have settled to grade 1 or lower. Dexamethasone dose must be stable in the week before joining. Cannot have had cell therapy, gene therapy or oncolytic virus therapy.
Main reasons for not taking part
- Two or more GBM lesions, or a lesion in the brainstem, cerebellum, posterior fossa or spinal cord
- History of autoimmune disease, immunodeficiency or organ transplant
- Active hepatitis B or hepatitis C
- Pregnant or breastfeeding women
- Other cancer types in the past, or another clinical trial at the same time
Read by machine on 9 November 2026.
Where in China
- Zhongnan Hospital of Wuhan UniversityWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhongnan Hospital
- Trial code
- NCT06757153
- Record updated
- 3 January 2025
- Original description
The goal of this clinical trial is to learn if NRG103 works to treat recurrent GBM in adults. It will also learn about the safety of NRG103.Read full original descriptionShow less
Clinical Study on the Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
The goal of this clinical trial is to learn if NRG103 works to treat recurrent GBM in adults. It will also learn about the safety of NRG103.
The main questions it aims to answer are:
Does NRG103 prolong overall survival or disease-free survival in patients with GBM? What medical problems do participants have when receiving NRG103 treatment? Researchers will give patients with NRG103 to see if NRG103 works to treat recurrent GBM.
Participants will:
Receive NRG103 twice in 14 days Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms
Inclusion: 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.
Exclusion: GBM lesion invades the ventricular wall or tumor cavity communicates with the ventricle after surgery; 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; 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.