RecruitingEarly Phase 1NCT06757153

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


Sponsor

Zhongnan Hospital

Enrollment

15 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called NRG-103, injected directly into a tumor cavity in the brain, for people with a type of aggressive brain cancer called glioblastoma (GBM) that has come back after initial treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with glioblastoma that has recurred after prior treatment - Your recurrent tumor has been surgically removed and a small reservoir device (Ommaya) has been placed in the cavity - You are in reasonably good health (Karnofsky score of 70 or above) with adequate blood, heart, liver, and kidney function **You may NOT be eligible if...** - You have had prior cell therapy, gene therapy, or oncolytic virus therapy - You have another active cancer - You have autoimmune disease, immune deficiency, or organ transplant history - You have active hepatitis B, hepatitis C, or poorly controlled diabetes - You have multiple GBM lesions or your tumor is in the brainstem or cerebellum - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNRG-103

NRG-103 is an oncolytic virus, which can kill GBM cells via three manners.


Locations(1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06757153


Related Trials