Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients
Trial ID: NCT06193538
Interventional - Phase 1 - Unknown status
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.
Conditions
- Advanced Glioblastoma Patients
Interventions
- Recombinant NV-A01 adenovirus injection
Eligibility
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.
Sponsor
First Affiliated Hospital of Wannan Medical College
Source: ClinicalTrials.gov
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