Actively Recruiting
Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
Led by Zhongnan Hospital · Updated on 2025-01-03
15
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed glioblastoma (WHO 2021)
- Recurrence of glioblastoma after previous anti-tumor treatments, with tumor surgically removed and Ommaya reservoir placed
- Recovery from previous treatment adverse reactions to Grade 1 or lower (NCI-CTCAE v5.0)
- Karnofsky Performance Score of 70 or higher
- Stable doses of dexamethasone during the week before inclusion
- Adequate bone marrow function: white blood cells >2.0 x 10^9/L, neutrophils >1.0 x 10^9/L, platelets >100 x 10^9/L, INR ≤1.5 times ULN, aPTT ≤1.5 times ULN
- Normal heart, kidney, and liver function
- Effective contraception for participants and their partners
- Written informed consent provided
You will not qualify if you...
- Allergy to components of the study drug or contrast agents
- Unable to undergo required imaging examinations
- History of cell therapy, gene therapy, or oncolytic virus therapy
- Participation in other clinical trials
- Use of anti-tumor vaccines or immunomodulatory drugs within 4 weeks
- History of other malignant tumors
- Unexplained fever
- History of autoimmune disease
- History of immunodeficiency or organ transplantation
- Active hepatitis B or C infection
- Severe heart disease (NYHA III or IV) or poorly controlled diabetes
- Two or more GBM lesions
- GBM lesion located in brainstem, cerebellum, posterior fossa, spinal cord, or leptomeningeal diseases
- History of diffuse subarachnoid diseases
- GBM lesion invading ventricular wall or tumor cavity communicating with ventricle after surgery
- History of encephalitis, multiple sclerosis, or other CNS infections
- Cerebral herniation syndrome
- Pregnant or lactating women
- Any other condition deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Z
Zhiqiang Li
CONTACT
F
Feng Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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