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The Safety and Effectiveness of NV-A01 in Glioma Patients | Clinical Trials | Clareo Health

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The Safety and Effectiveness of NV-A01 in Glioma Patients

Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients

NCT06193538•First Affiliated Hospital of Wannan Medical College

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Wannan medical college hospital

Wuhu, Jiangsu, China

Key Dates

Start Date

September 14, 2023

Primary Completion Date

December 1, 2024

Completion Date

July 1, 2025

Last Updated

January 5, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced Glioblastoma Patients

Interventions

Recombinant NV-A01 adenovirus injection

DRUG

Contacts

Jie Shen, Doctor

CONTACT

86 553 5738200 5845348@qq.com