The Safety and Effectiveness of NV-A01 in Glioma Patients

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Wannan Medical College

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.