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The Safety and Effectiveness of NV-A01 in Glioma Patients

The Safety and Effectiveness of NV-A01 in Glioma Patients

Recruiting
18-65 years
All
Phase 1

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Overview

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.

Eligibility

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 details
    Advanced Glioblastoma Patients

NCT06193538

First Affiliated Hospital of Wannan Medical College

27 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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