Actively Recruiting
Study of NRG-103 Injection Safety and Effectiveness in Adults with Recurrent Glioblastoma
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
Researchers are evaluating the safety and effectiveness of NRG-103, a gene therapy drug, in adults with recurrent glioblastoma (GBM), a highly invasive and malignant brain tumor. GBM often returns after treatments like surgery, radiotherapy, and chemotherapy, with a median survival time after recurrence of only 9 months. NRG-103 is designed to target and kill GBM tumor cells, regulate the immune system to attack tumors, and convert remaining tumor cells into non-tumor neuronal cells to delay recurrence and improve survival. Participants in this early-phase study will receive two doses of NRG-103 within 14 days. The treatment involves injecting the oncolytic virus directly into the brain tumor cavity through an Ommaya reservoir placed during previous surgery. The study will monitor how well NRG-103 works to prolong survival and disease-free periods after treatment. During the study, participants will visit the clinic every two weeks for checkups and tests, and keep a diary to record their symptoms. Researchers will assess progression-free survival six months after treatment and monitor for medical issues during therapy. The study includes careful safety evaluations and ongoing monitoring to understand the impact of NRG-103 over time.
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
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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
F
Feng Tang
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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