Treatment of recurrent glioblastoma with NRG-103 injection

Clinical Study on the Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients

This study is testing if a new gene therapy called NRG-103 can help adults with recurrent glioblastoma live longer and feel better after receiving two injections.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06757153 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of NRG-103, an innovative gene therapy, in treating adults with recurrent glioblastoma (GBM). Participants will receive NRG-103 injections twice within a 14-day period and will undergo regular check-ups and symptom tracking. The study seeks to determine whether NRG-103 can prolong overall survival or disease-free survival in these patients, while also monitoring any medical issues that arise during treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed recurrent glioblastoma who have undergone previous anti-tumor treatments.

Not a fit: Patients with allergies to the components of NRG-103 or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent glioblastoma, potentially improving survival rates.

How similar studies have performed: Other studies involving oncolytic virus therapies for glioblastoma have shown promising results, indicating potential for success with this novel approach.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Zhiqiang Li — Zhongnan Hospital
• Study coordinator: Zhiqiang Li

Conditions Glioblastoma; Oncolytic virus; NRG103; Trans-differentiation