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

NCT07710690 | Recruiting Phase 1 DMC

• 1 other identifier: NeuregenThera
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HGG; High Grade Glioma (III or IV); High Grade Glioma

Outcome Measures

Primary Outcomes (2)

• AE/SAE/AESI

  2 year

• DLT

  8 weeks

Secondary Outcomes (1)

• PFS6

  2 years

Study Arms (1)

NRG-103

EXPERIMENTAL

Drug: NRG-103

Interventions

NRG-103 DRUG

NRG-103

NRG-103

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• , 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.

Sponsors & Collaborators

• Neuregen Therapeutics Co., Ltd.: lead

Study Sites (3)

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

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Chris Wang

CONTACT

+86 186 1657 2030; wangxiaochen@nrg-therapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (3)