The Safety and Effectiveness of NV-A01 in Glioma Patients

NCT ID: NCT06193538

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-14
• Study Completion Date: 2025-07-31

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-A01 in the treatment of advanced glioblastoma patients.

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

Conditions

Advanced Glioblastoma Patients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intratumoral injection of NV-A01 adenovirus

Group Type: EXPERIMENTAL

Recombinant NV-A01 adenovirus injection

Intervention Type: DRUG

Patients with advanced glioblastoma were intratumoral injected with NV-A01. Or the NV-A01 was injected after tumor resection.

Interventions

Recombinant NV-A01 adenovirus injection

Patients with advanced glioblastoma were intratumoral injected with NV-A01. Or the NV-A01 was injected after tumor resection.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Jiang Xiao-chun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao Chun Jiang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Wannan Medical College Hospital

Locations

Wannan medical college hospital

Wuhu, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Shen, Doctor

Role: CONTACT

5845348@qq.com

86 553 5738200

Facility Contacts

Jie Shen

Role: primary

86 159 2231 8586

Other Identifiers

2023IIT003

Identifier Type: -

Identifier Source: org_study_id