The Safety and Effectiveness of NV-A01 in Glioma Patients

Phase 1

Recruiting

• Conditions: Advanced Glioblastoma Patients
• Interventions: Drug: Recombinant NV-A01 adenovirus injection

• Registration Number: NCT06193538
• Lead Sponsor: First Affiliated Hospital of Wannan Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-14
• Study First Submitted: 2023-09-15
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intratumoral injection of NV-A01 adenovirus	Recombinant NV-A01 adenovirus injection	-

Primary Outcome Measures

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

Name	Time	Method
Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma	Six months after the last injection	Evaluate objective response rate (ORR), disease control rate (DCR), and progression free survival (PFS) according to the evaluation criteria for solid tumor efficacy (RECIST 1.1).
Developing pharmacodynamic indicators Discovering pharmacodynamic indicators Discovering pharmacodynamic indicators	Six months after the last injection	Proportion of CD3+, CD4+, CD8+T cells and the expression of CD69 on the surface of T cells in peripheral blood are detected by flow cytometry. The concentration of IL2 and IFN-gamma in plasma are measured by ELISA. Samples are collected prior to the administration of NV-A01 and at regular intervals after treatment.

Trial Locations

Locations (1)

Wannan medical college hospital; 🇨🇳 Wuhu, Jiangsu, China