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The Safety and Effectiveness of NV-A01 in Glioma Patients

Study Purpose

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. The effectiveness of NV-A01 in treating patients with advanced glioblastoma.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with advanced malignant glioma confirmed by histopathology; 2. Patients who have received radiotherapy and/or temozolomide (TMZ) treatment and have residual or recurrent tumors; 3. Patients diagnosed with lesions ≥ 1.0 cm after qualified assessment; 4. KPS score ≥ 60 points; 5. The subjects had informed consent to this study before the experiment and voluntarily signed an informed consent form.

Exclusion Criteria:

1. 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; 2. Patients with severe cardiovascular diseases, active autoimmune diseases, and other diseases that have been determined by researchers to be unsuitable for enrollment; 3. 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; 4. Patients with an expected survival period of less than 3 months and judged by the researchers as unsuitable for enrollment; 5. Researchers believe that patients with other serious systemic diseases or other reasons are not suitable for participating in this clinical study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06193538
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	First Affiliated Hospital of Wannan Medical College
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Xiao Chun Jiang, Doctor
Principal Investigator Affiliation	Wannan Medical College Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Glioblastoma Patients

Arms & Interventions

Arms

Experimental: Intratumoral injection of NV-A01 adenovirus

Interventions

Drug: - Recombinant NV-A01 adenovirus injection

Patients with advanced glioblastoma were intratumoral injected with NV-A01. Or the NV-A01 was injected after tumor resection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Wannan medical college hospital, Wuhu, Jiangsu, China

Status

Recruiting

Address

Wannan medical college hospital

Wuhu, Jiangsu,

Site Contact

Jie Shen

[email protected]

86 159 2231 8586

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