Overview
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.