Clinical trial · Interventional
Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
Clinical Study on the Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
NCT06757153CI-TRIAL-00084311recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NRG-103 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NRG-103
- description
- NRG-103 is an innovative gene therapy drug developed based on the in situ trans-differentiation technology. Through multiple mutation modifications of the adenovirus genome, it can enhance the specific recognition and killing effect of oncolytic virus on GBM tumor cells without being limited by tumor gene phenotype, and regulate the immune microenvironment to induce stronger anti-tumor immune response. In addition, the two transcription factors expressed on NRG-103 can efficiently transdifferentiate residual GBM tumor cells into non tumor like neuronal cells, in order to achieve the goal of delaying tumor recurrence and long-term survival.
- interventionNames
- Drug: NRG-103
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 6 months after NRG-103 treatment
- description
- The participants will be followed until disease progression by RANO criteria
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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: 1. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.