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Clinical Trials in China / NCT07710690
Recruiting Phase 1

A Clinical Trial Evaluating the Tolerability, Safety, and Preliminary Efficacy of NRG-103 Injection in Patients With Recurrent or Progressive High-grade Glioma

NCT07710690 · tracked via the Priya Life Science China tracker
Sponsor
Neuregen Therapeutics Co., Ltd.
Phase
Phase 1
Started
2026-07-09
Last updated
2026-07-17

Condition(s) studied

HGGHigh Grade Glioma (III or IV)High Grade Glioma

Investigational drug(s) / intervention(s)

NRG-103

NRG-103: NRG-103

Study summary

The primary objective of this study is to determine the safe dose range of NRG-103 in patients and to recommend the dosage for subsequent treatment, while also evaluating the preliminary efficacy and tolerability of the product.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Willing to voluntarily participate in the study, able to sign the Informed Consent Form (ICF), and willing to comply with the procedures specified in the study protocol. * Age ≥18 years, regardless of gender. * Participants must have a prior diagnosis of World Health Organization (WHO) Grade 3 or 4 glioma, according to the WHO (2021) classification criteria. A pathology report containing histopathological typing and necessary molecular pathology test results must be provided; this report will serve as sufficient histological documentation for study enrollment. * Patients must have exhausted standard anti-tumor therapies or be intolerant to standard treatments (including chemoradiotherapy, targeted therapy, or immunotherapy), as evidenced by the occurrence of Grade ≥3 non-hematologic toxicities or Grade 4 hematologic toxicities. There must be definitive evidence of recurrent or progressive glioma on magnetic resonance imaging (MRI) scans (assessed according to the RANO 2.0 criteria), with no recognized effective treatment options remaining. If MRI scans are inconclusive regarding tumor recurrence or progression, surgery/biopsy is recommended; however, surgery/biopsy is not required if the investigator determines that the combination of the imaging report and clinical manifestations is sufficient to indicate tumor recurrence or progression. Exclusion Criteria: * Patients with known or suspected hypersensitivity to any components of the investigational medicinal product or to contrast agents. * Patients with contraindications to magnetic resonance imaging (MRI) scanning, including but not limited to: cardiac pacemakers, epicardial pacing leads, surgical and/or aneurysm clips, shrapnel, metal prostheses, potentially magnetically active implants, metallic foreign bodies in the eye, and non-removable metal dentures. * Patients with a history of prior gene therapy or oncolytic virus therapy. * Patients who have participated in other clinical trials and received other investigational drugs within 28 days prior to the first administration of NRG-103. 5, Patients who have received anti-tumor vaccines or other immunomodulatory agents (e.g., interferons, interleukin-2, thymosin, lentinan, etc.) within 4 weeks prior to enrollment. Patients who have received or are scheduled to receive live attenuated or recombinant vaccines within 4 weeks; or patients who have received or are scheduled to receive inactivated vaccines within 1 week.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Huashan Hospital Affiliated with Fudan University Shanghai China Recruiting
Zhongnan Hospital of Wuhan University Wuhan China Recruiting
The Second Affiliated Hospital of Air Force Medical University Xi'an China Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07710690 on ClinicalTrials.gov ↗ ← All trials in China