The Safety and Effectiveness of NV-A01 in Glioma Patients

First Affiliated Hospital of Wannan Medical College

Status and phase: Enrolling; Phase 1

Conditions: Advanced Glioblastoma Patients

Treatments: Drug: Recombinant NV-A01 adenovirus injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06193538

2023IIT003

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intratumoral injection of NV-A01 adenovirus

Experimental group

Treatment:

Drug: Recombinant NV-A01 adenovirus injection