Glioblastoma (GBM)Early Phase 1NCT06757153
Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
A Early Phase 1 study testing NRG-103 in people with Glioblastoma (GBM), run by Zhongnan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if NRG103 works to treat recurrent GBM in adults. It will also learn about the safety of NRG103. The main questions it aims to answer are: Does NRG103 prolong overall survival or disease-free survival in patients with GBM? What medical problems do participants have when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- NRG-103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2024to Dec 2027
- Phase
- Early 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
- Age≥18 years.
- Patients must have histologically or cytologically confirmed glioblastoma(WHO 2021).
- Patients have experienced recurrence (RANO 2.0) after previous anti-tumor treatments, including the recurrent tumor has been surgically removed and an Ommaya reservoir has been placed inside the tumor cavity.
- The relevant adverse reactions from the previous treatment have been restored to ≤1 level(NCI-CTCAE v5.0).
- Karnofsky Performance Score≥70.
- Stable doses of dexamethasone during the week prior to inclusion.
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- Adequate bone marrow reserve: White blood cell count>2.0 × 109/L, neutrophil count>1.0 × 109/L, platelet count>100 × 109/L, international normalized ratio ≤1.5 times ULN, and activated partial thromboplastin time≤1.5 times ULN.
- Normal heart, renal and liver function.
- Effective method of contraception for patients and their partners.
- Written informed consent.
Who cannot join
- Allergy to the components of the test drug and contrast agent.
- Unable to undergo imaging examinations required for the research.
- A history of cell therapy, gene therapy, or oncolytic virus therapy.
- Undergoing other clinical trials.
- A history of anti-tumor vaccines or other immunomodulatory drugs with 4 weeks.
- A history of other type of malignant tumors.
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- Unexplained fever.
- A history of autoimmune disease.
- A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Active hepatitis B, or hepatitis C.
- Severe heart disease (NYHA III or IV), or poorly controlled diabetes.
- Two or more GBM lesions.
- GBM lesion located in the brainstem, cerebellum, posterior fossa, or spinal cord, as well as leptomeningeal diseases.
- A history of diffuse subarachnoid and subarachnoid diseases.
- GBM lesion invades the ventricular wall or tumor cavity communicates with the ventricle after surgery.
- A history of encephalitis, multiple sclerosis, or other central nervous system infections.
- Cerebral herniation syndrome.
- Pregnant and lactating women.
- Other situations that the researcher deems unsuitable for entry into the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Zhiqiang Li, +8618907123005, lizhiqiang@whu.edu.cn
About this study
Official title: Clinical Study on the Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
The goal of this clinical trial is to learn if NRG103 works to treat recurrent GBM in adults. It will also learn about the safety of NRG103.
The main questions it aims to answer are:
Does NRG103 prolong overall survival or disease-free survival in patients with GBM? What medical problems do participants have when receiving NRG103 treatment? Researchers will give patients with NRG103 to see if NRG103 works to treat recurrent GBM.
Participants will:
Receive NRG103 twice in 14 days Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms
Read the detailed description
The annual incidence rate of malignant brain tumors in China is 4.2/100000, and GBM accounts for 50.9%. GBM is highly invasive and malignant. After undergoing anti-tumor treatments such as surgery, radiotherapy, and chemotherapy, the short-term recurrence rate is extremely high. The median survival time after recurrence is only 9 months, and the 1-year survival rate is 30%. It is urgent to explore new therapy strategy.
Transgenic oncolytic virus therapy for GBM is an emerging anti-tumor therapy. The genetically engineered oncolytic virus has improved selectivity towards tumor cells, replicating and lysing only within infected tumor cells, while activating the body's immune system to launch a more extensive attack on tumors. At present, various genetically modified oncolytic viruses targeting GBM have entered the clinical trial stage both domestically and internationally. For example, G47Δ, with superior anti-tumor activity and good safety in early clinical trials, has been conditionally approved for marketing in Japan for the treatment of malignant gliomas. DNX-2401, JL15003, and others are also in the early stages of clinical research. NRG-103 is an innovative gene therapy drug developed based on the in situ trans-differentiation technology. Through multiple mutation modifications of the adenovirus genome, it can enhance the specific recognition and killing effect of oncolytic virus on GBM tumor cells without being limited by tumor gene phenotype, and regulate the immune microenvironment to induce stronger anti-tumor immune response. In addition, the two transcription factors expressed on NRG-103 can efficiently transdifferentiate residual GBM tumor cells into non tumor like neuronal cells, in order to achieve the goal of delaying tumor recurrence and long-term survival. NRG-103 exhibits significant anti-tumor activity and clear in situ trans-differentiation effects in preclinical models, providing scientific evidence for the potential clinical efficacy of NRG-103.
- Conditions
- Glioblastoma (GBM)
- Being tested
- NRG-103
- Keywords
- Glioblastoma;Oncolytic virus;NRG103;Trans-differentiation;
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRG-103Drug
NRG-103 is an oncolytic virus, which can kill GBM cells via three manners.
| Study group | Role | What they receive |
|---|---|---|
| NRG-103 | Experimental | NRG-103 is an innovative gene therapy drug developed based on the in situ trans-differentiation technology. Through multiple mutation modifications of the adenovirus genome, it can enhance the specific recognition and killing effect of oncolytic virus on GBM tumor cells without being limited by tumor gene phenotype, and regulate the immune microenvironment to induce stronger anti-tumor immune response. In addition, the two transcription factors expressed on NRG-103 can efficiently transdifferentiate residual GBM tumor cells into non tumor like neuronal cells, in order to achieve the goal of delaying tumor recurrence and long-term survival. Receives: Drug: NRG-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The participants will be followed until disease progression by RANO criteria
Measured: 6 months after NRG-103 treatment
Secondary outcomes (1)
Overall survival
The participants will be followed until death
Measured: 12 months after NRG-103 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start19 Dec 2024
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiqiang Li, Zhongnan Hospital
- Investigators
- Zhiqiang Li, Principal investigator, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757153
- Sponsor's protocol ID
- NRG103001
- Other IDs
- ChiCTR2400093705
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data related to this clinical trial will be protected by Zhongnan Hospital
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT06757153
- Acronym / sponsor ID
- NRG103001
- Conditions
- Glioblastoma (GBM)
- Keywords
- Glioblastoma;Oncolytic virus;NRG103;Trans-differentiation;
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jan 2025 (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 goal of this clinical trial is to learn if NRG103 works to treat recurrent GBM in adults. It will also learn about the safety of NRG103.
The main questions it aims to answer are:
Does NRG103 prolong overall survival or disease-free survival in patients with GBM? What medical problems do participants have when receiving NRG103 treatment? Researchers will give patients with NRG103 to see if NRG103 works to treat recurrent GBM.
Participants will:
Receive NRG103 twice in 14 days Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms
Detailed description
The annual incidence rate of malignant brain tumors in China is 4.2/100000, and GBM accounts for 50.9%. GBM is highly invasive and malignant. After undergoing anti-tumor treatments such as surgery, radiotherapy, and chemotherapy, the short-term recurrence rate is extremely high. The median survival time after recurrence is only 9 months, and the 1-year survival rate is 30%. It is urgent to explore new therapy strategy.
Transgenic oncolytic virus therapy for GBM is an emerging anti-tumor therapy. The genetically engineered oncolytic virus has improved selectivity towards tumor cells, replicating and lysing only within infected tumor cells, while activating the body's immune system to launch a more extensive attack on tumors. At present, various genetically modified oncolytic viruses targeting GBM have entered the clinical trial stage both domestically and internationally. For example, G47Δ, with superior anti-tumor activity and good safety in early clinical trials, has been conditionally approved for marketing in Japan for the treatment of malignant gliomas. DNX-2401, JL15003, and others are also in the early stages of clinical research. NRG-103 is an innovative gene therapy drug developed based on the in situ trans-differentiation technology. Through multiple mutation modifications of the adenovirus genome, it can enhance the specific recognition and killing effect of oncolytic virus on GBM tumor cells without being limited by tumor gene phenotype, and regulate the immune microenvironment to induce stronger anti-tumor immune response. In addition, the two transcription factors expressed on NRG-103 can efficiently transdifferentiate residual GBM tumor cells into non tumor like neuronal cells, in order to achieve the goal of delaying tumor recurrence and long-term survival. NRG-103 exhibits significant anti-tumor activity and clear in situ trans-differentiation effects in preclinical models, providing scientific evidence for the potential clinical efficacy of NRG-103.
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-103NRG-103 is an innovative gene therapy drug developed based on the in situ trans-differentiation technology. Through multiple mutation modifications of the adenovirus genome, it can enhance the specific recognition and killing effect of oncolytic virus on GBM tumor cells without being limited by tumor gene phenotype, and regulate the immune microenvironment to induce stronger anti-tumor immune response. In addition, the two transcription factors expressed on NRG-103 can efficiently transdifferentiate residual GBM tumor cells into non tumor like neuronal cells, in order to achieve the goal of delaying tumor recurrence and long-term survival. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age≥18 years.
- Patients must have histologically or cytologically confirmed glioblastoma(WHO 2021).
- Patients have experienced recurrence (RANO 2.0) after previous anti-tumor treatments, including the recurrent tumor has been surgically removed and an Ommaya reservoir has been placed inside the tumor cavity.
- The relevant adverse reactions from the previous treatment have been restored to ≤1 level(NCI-CTCAE v5.0).
- Karnofsky Performance Score≥70.
Key exclusion criteria (19 listed)
- Allergy to the components of the test drug and contrast agent.
- Unable to undergo imaging examinations required for the research.
- A history of cell therapy, gene therapy, or oncolytic virus therapy.
- Undergoing other clinical trials.
- A history of anti-tumor vaccines or other immunomodulatory drugs with 4 weeks.
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 is an oncolytic virus, which can kill GBM cells via three manners. | Drug | NRG-103 |
Primary outcome
Progression-free survival
Time frame: 6 months after NRG-103 treatment
The participants will be followed until disease progression by RANO criteria
1 secondary outcome
Overall survival
Time frame: 12 months after NRG-103 treatment
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 3 Jan 2025.
- Individual participant dataSharing planned: No. Data related to this clinical trial will be protected by Zhongnan Hospital
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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.
Zhiqiang Li principal investigator
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NRG-103 in people with Glioblastoma (GBM), run by Zhongnan Hospital at 1 site 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 10 inclusion and 19 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 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Zhiqiang Li (+86-18907123005, lizhiqiang@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 6 months after NRG-103 treatment). 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 3 Jan 2025.