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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Evaluating the Tolerability, Safety, and Preliminary Efficacy of NRG-103 Injection in Patients With Recurrent or Progressive High-grade Glioma
- ClinicalTrials.gov ID
- NCT07710690
- Acronym / sponsor ID
- NeuregenThera
- Conditions
- HGG, High Grade Glioma (III or IV), High Grade Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Neuregen Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRG-103 | Experimental | Drug: NRG-103 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRG-103NRG-103 | Drug | NRG-103 |
Primary outcome
AE/SAE/AESI
Time frame: 2 year
DLT
Time frame: 8 weeks
1 secondary outcome
PFS6
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Wang (+86 186 1657 2030, wangxiaochen@nrg-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE/SAE/AESI (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.