Status:
UNKNOWN
The Safety and Effectiveness of NV-A01 in Glioma Patients
Lead Sponsor:
First Affiliated Hospital of Wannan Medical College
Conditions:
Advanced Glioblastoma Patients
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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-A0...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06193538
Start Date
September 14 2023
End Date
July 1 2025
Last Update
January 5 2024
Active Locations (1)
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1
Wannan medical college hospital
Wuhu, Jiangsu, China