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

First Affiliated Hospital of Wannan Medical College1 site in 1 country15 target enrollmentSeptember 14, 2023

ConditionsAdvanced Glioblastoma Patients

InterventionsRecombinant NV-A01 adenovirus injection

DrugsRecombinant NV-A01 adenovirus injection

Overview

Phase: Phase 1
Intervention: Recombinant NV-A01 adenovirus injection
Conditions: Advanced Glioblastoma Patients
Sponsor: First Affiliated Hospital of Wannan Medical College
Enrollment: 15
Locations: 1
Primary Endpoint: Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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:

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

Registry

clinicaltrials.gov

Start Date

September 14, 2023

End Date

July 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

First Affiliated Hospital of Wannan Medical College

Responsible Party

Principal Investigator

Jiang Xiao-chun

Professor

First Affiliated Hospital of Wannan Medical College

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Arms & Interventions

Intratumoral injection of NV-A01 adenovirus

Intervention: Recombinant NV-A01 adenovirus injection

Outcomes

Primary Outcomes

Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events

Time Frame: One months after the last injection

All events with a Grade 3 or above toxicity (defined by the NCI-CTCAE 5.0) will be tabulated by event and by relationship to NV-A01.

Secondary Outcomes

Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma(Six months after the last injection)
Developing pharmacodynamic indicators Discovering pharmacodynamic indicators Discovering pharmacodynamic indicators(Six months after the last injection)