Advanced Glioblastoma PatientsPhase 1NCT06193538
The Safety and Effectiveness of NV-A01 in Glioma Patients
A Phase 1 study testing Recombinant NV-A01 adenovirus injection in people with Advanced Glioblastoma Patients, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the safety and effectiveness of NV-A01 in the treatment of advanced glioma patients. The main questions it aims to answer are: 1. The safety of NV-A01 in the treatment of advanced glioblastoma patients. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Glioblastoma Patients
- What is being tested?
- Recombinant NV-A01 adenovirus injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2023to Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced malignant glioma confirmed by histopathology;
- Patients who have received radiotherapy and/or temozolomide (TMZ) treatment and have residual or recurrent tumors;
- Patients diagnosed with lesions ≥ 1.0 cm after qualified assessment;
- KPS score ≥ 60 points;
- The subjects had informed consent to this study before the experiment and voluntarily signed an informed consent form.
Who cannot join
- Patients with unstable central nervous system metastases or meningeal metastases with clinical symptoms, with a risk of brain herniation or severe brain herniation, and judged by researchers as unsuitable for inclusion;
- Patients with severe cardiovascular diseases, active autoimmune diseases, and other diseases that have been determined by researchers to be unsuitable for enrollment;
- Patients who have received immunotherapy in the past and have an irAE level ≥ 3, and have been determined by the researchers to be unsuitable for enrollment;
- Patients with an expected survival period of less than 3 months and judged by the researchers as unsuitable for enrollment;
- Researchers believe that patients with other serious systemic diseases or other reasons are not suitable for participating in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wannan medical college hospital
Wuhu, Jiangsu
Jie Shen, 86 159 2231 8586
About this study
Official title: Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients
The goal of this clinical trial is to learn about the safety and effectiveness of NV-A01 in the treatment of advanced glioma patients. The main questions it aims to answer are:
- The safety of NV-A01 in the treatment of advanced glioblastoma patients.
- The effectiveness of NV-A01 in treating patients with advanced glioblastoma.
- Conditions
- Advanced Glioblastoma Patients
- Being tested
- Recombinant NV-A01 adenovirus injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant NV-A01 adenovirus injectionDrug
Patients with advanced glioblastoma were intratumoral injected with NV-A01. Or the NV-A01 was injected after tumor resection.
| Study group | Role | What they receive |
|---|---|---|
| Intratumoral injection of NV-A01 adenovirus | Experimental | Not described Receives: Drug: Recombinant NV-A01 adenovirus injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events
All events with a Grade 3 or above toxicity (defined by the NCI-CTCAE 5.0) will be tabulated by event and by relationship to NV-A01.
Measured: One months after the last injection
Secondary outcomes (2)
Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma
Evaluate objective response rate (ORR), disease control rate (DCR), and progression free survival (PFS) according to the evaluation criteria for solid tumor efficacy (RECIST 1.1).
Measured: Six months after the last injection
Developing pharmacodynamic indicators Discovering pharmacodynamic indicators Discovering pharmacodynamic indicators
Proportion of CD3+, CD4+, CD8+T cells and the expression of CD69 on the surface of T cells in peripheral blood are detected by flow cytometry. The concentration of IL2 and IFN-gamma in plasma are measured by ELISA. Samples are collected prior to the administration of NV-A01 and at regular intervals after treatment.
Measured: Six months after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start14 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Glioblastoma PatientsStudies 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
- Model description
- This trial is a single arm, single center IIT clinical study to evaluate the safety and efficacy of NV-A01 in patients with advanced glioblastoma.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Xiao-chun, First Affiliated Hospital of Wannan Medical College
- Investigators
- Xiao Chun Jiang, Doctor, Principal investigator, Wannan Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193538
- Sponsor's protocol ID
- 2023IIT003
- Status last verified
- Dec 2023
- First submitted
- 15 Sep 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients
- ClinicalTrials.gov ID
- NCT06193538
- Acronym / sponsor ID
- 2023IIT003
- Conditions
- Advanced Glioblastoma Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 5 Jan 2024 (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 about the safety and effectiveness of NV-A01 in the treatment of advanced glioma patients. The main questions it aims to answer are:
- The safety of NV-A01 in the treatment of advanced glioblastoma patients.
- The effectiveness of NV-A01 in treating patients with advanced glioblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is a single arm, single center IIT clinical study to evaluate the safety and efficacy of NV-A01 in patients with advanced glioblastoma.
| Arm | Type | Receives |
|---|---|---|
| Intratumoral injection of NV-A01 adenovirus | Experimental | Drug: Recombinant NV-A01 adenovirus injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with advanced malignant glioma confirmed by histopathology;
- Patients who have received radiotherapy and/or temozolomide (TMZ) treatment and have residual or recurrent tumors;
- Patients diagnosed with lesions ≥ 1.0 cm after qualified assessment;
- KPS score ≥ 60 points;
- The subjects had informed consent to this study before the experiment and voluntarily signed an informed consent form.
Key exclusion criteria (5 listed)
- Patients with unstable central nervous system metastases or meningeal metastases with clinical symptoms, with a risk of brain herniation or severe brain herniation, and judged by researchers as unsuitable for inclusion;
- Patients with severe cardiovascular diseases, active autoimmune diseases, and other diseases that have been determined by researchers to be unsuitable for enrollment;
- Patients who have received immunotherapy in the past and have an irAE level ≥ 3, and have been determined by the researchers to be unsuitable for enrollment;
- Patients with an expected survival period of less than 3 months and judged by the researchers as unsuitable for enrollment;
- Researchers believe that patients with other serious systemic diseases or other reasons are not suitable for participating in this clinical study.
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 |
|---|---|---|
| Recombinant NV-A01 adenovirus injectionPatients with advanced glioblastoma were intratumoral injected with NV-A01. Or the NV-A01 was injected after tumor resection. | Drug | Intratumoral injection of NV-A01 adenovirus |
Primary outcome
Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events
Time frame: One months after the last injection
All events with a Grade 3 or above toxicity (defined by the NCI-CTCAE 5.0) will be tabulated by event and by relationship to NV-A01.
2 secondary outcomes
Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma
Time frame: Six months after the last injection
Developing pharmacodynamic indicators Discovering pharmacodynamic indicators Discovering pharmacodynamic indicators
Time frame: Six months after the last injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Xiao Chun Jiang, Doctor principal investigator
Wannan Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant NV-A01 adenovirus injection in people with Advanced Glioblastoma Patients, run by First Affiliated Hospital of Wannan Medical College 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 5 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Shen, Doctor (86 553 5738200, 5845348@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events (time frame: One months after the last injection). 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 5 Jan 2024.