Taste of hope: testing NRG-103 safety and dosing for adults with high-grade glioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study to determine a safe and potentially effective dose range for NRG-103 in adults with WHO grade 3 or 4 glioma who have exhausted standard therapies. The trial will monitor safety, tolerability, and preliminary efficacy to guide dose selection for future studies. Participants will receive NRG-103 and undergo regular assessments, including imaging and laboratory tests, to evaluate responses and adverse events. Enrollment is limited to adults with documented recurrent or progressive disease and adequate organ function, at multiple collaborating centers in China. The lead sponsor is Neuregen Therapeutics Co., Ltd., with participating sites at Huashan Hospital (Shanghai), Zhongnan Hospital (Wuhan), and The Second Affiliated Hospital of the Air Force Medical University (Xi'an).

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Chris Wang
• Email: wangxiaochen@nrg-therapeutics.com
• Phone: +86 186 1657 2030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.