HGGPhase 1NCT07710690
A Clinical Trial Evaluating the Tolerability, Safety, and Preliminary Efficacy of NRG-103 Injection in Patients With Recurrent or Progressive High-grade Glioma
A Phase 1 study testing NRG-103 in people with HGG and High Grade Glioma (III or IV), run by Neuregen Therapeutics Co., Ltd. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HGG, High Grade Glioma (III or IV), High Grade Glioma
- What is being tested?
- NRG-103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesChina
- Study dates
- 9 Jul 2026to 30 Apr 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Huashan Hospital Affiliated with Fudan University
Shanghai
PI, +86 21 5288 8828
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
PI, +86 27 67812888
- Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi'an
About this study
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
- Being tested
- NRG-103
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRG-103Drug
NRG-103
| Study group | Role | What they receive |
|---|---|---|
| NRG-103 | Experimental | Not described Receives: Drug: NRG-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE/SAE/AESI
Measured: 2 year
DLT
Measured: 8 weeks
Secondary outcomes (1)
PFS6
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start9 Jul 2026
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HGGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuregen Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710690
- Sponsor's protocol ID
- NeuregenThera
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No