Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
ConditionGlioblastoma (GBM)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongnan Hospital
About this trial
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 criteria
Qualifiers
Age≥18 years.
Patients must have histologically or cytologically confirmed glioblastoma(WHO 2021).
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.
The relevant adverse reactions from the previous treatment have been restored to ≤1 level(NCI-CTCAE v5.0).
Disqualifiers
Allergy to the components of the test drug and contrast agent.
Unable to undergo imaging examinations required for the research.
A history of cell therapy, gene therapy, or oncolytic virus therapy.
Undergoing other clinical trials.
Trial design
Treatments tested in this trial
- NRG-103
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov