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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Glioblastoma Patients
• Intervention / Treatment: Drug: Recombinant NV-A01 adenovirus injection

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jie Shen, Doctor; Phone Number: 86 553 5738200; Email: 5845348@qq.com

Study Locations

• China
  • Jiangsu
    • Wuhu, Jiangsu, China
      • Recruiting
      • Wannan medical college hospital
      • Contact: Jie Shen; Phone Number: 86 159 2231 8586

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intratumoral injection of NV-A01 adenovirus	Drug: Recombinant NV-A01 adenovirus injection; Patients with advanced glioblastoma were intratumoral injected with NV-A01. Or the NV-A01 was injected after tumor resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events	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.	One months after the last injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma	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).	Six months after the last injection
Developing pharmacodynamic indicators Discovering pharmacodynamic indicators Discovering pharmacodynamic indicators	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.	Six months after the last injection

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wannan Medical College
• Investigators: Principal Investigator: Xiao Chun Jiang, Doctor, Wannan medical college hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 2023IIT003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No