Clinical Study on the Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
Trial ID: NCT06757153
Interventional - Phase 1 - Recruiting
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
Glioblastoma (GBM)
Interventions
NRG-103
Eligibility
Inclusion criteria
Age≥18 years.
2. Patients must have histologically or cytologically confirmed glioblastoma(WHO 2021).
3. 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.
4. The relevant adverse reactions from the previous treatment have been restored to ≤1 level(NCI-CTCAE v5.0).
5. Karnofsky Performance Score≥70.
6. Stable doses of dexamethasone during the week prior to inclusion.
7. 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.
8. Normal heart, renal and liver function.
9. Effective method of contraception for patients and their partners.
10. Written informed consent.
Exclusion criteria
Allergy to the components of the test drug and contrast agent.
2. Unable to undergo imaging examinations required for the research.
3. A history of cell therapy, gene therapy, or oncolytic virus therapy.
4. Undergoing other clinical trials.
5. A history of anti-tumor vaccines or other immunomodulatory drugs with 4 weeks.
6. A history of other type of malignant tumors.
7. Unexplained fever.
8. A history of autoimmune disease.
9. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
10. Active hepatitis B, or hepatitis C.
11. Severe heart disease (NYHA III or IV), or poorly controlled diabetes.
12. Two or more GBM lesions.
13. GBM lesion located in the brainstem, cerebellum, posterior fossa, or spinal cord, as well as leptomeningeal diseases.
14. A history of diffuse subarachnoid and subarachnoid diseases.
15. GBM lesion invades the ventricular wall or tumor cavity communicates with the ventricle after surgery.
16. A history of encephalitis, multiple sclerosis, or other central nervous system infections.
17. Cerebral herniation syndrome.
18. Pregnant and lactating women.
19. Other situations that the researcher deems unsuitable for entry into the study.