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A49

A groundbreaking clinical trial is underway to evaluate the effectiveness of a new adjuvant vaccine, known as A49, for patients with glioblastoma. This Phase 1/2a study, called NAVIG-1, aims to assess the safety, immune response, and potential benefits of A49 in combination with other treatments for this aggressive form of brain cancer. The trial focuses on patients who have already undergone initial treatment and seeks to improve their outcomes through this innovative approach.

Table of Contents

What is A49?

A49 is a new experimental treatment being studied for patients with glioblastoma, which is a type of aggressive brain cancer[1]. It is classified as a peptide (a small protein-like molecule) and is being developed as a vaccine to help the immune system fight against glioblastoma cells.

The full name of the treatment is “Peptide A49 associated to melanin,” and it’s being tested in a clinical trial called NAVIG-1 (New Adjuvant Vaccine in Glioblastoma)[1]. This vaccine is given as a solution for injection and is administered subcutaneously (under the skin), typically in the shoulders.

How A49 Works

A49 is designed to work as a therapeutic vaccine, which means it aims to stimulate the patient’s immune system to recognize and attack glioblastoma cells. The vaccine targets two specific proteins found in glioblastoma tumors:

  • PTPRZ1: A protein that may be involved in the growth and spread of glioblastoma cells
  • TERT: An enzyme that helps cancer cells divide indefinitely

By targeting these proteins, A49 aims to trigger an immune response specifically against glioblastoma cells[1]. The vaccine is given along with another substance called Litenimod, which likely helps boost the immune response.

Clinical Trial Details

The NAVIG-1 trial is a Phase 1/2a study, which means it’s an early-stage trial designed to test the safety and initial effectiveness of A49[1]. The trial is divided into two parts:

  1. Phase 1: This part aims to determine the safest and most effective dose of A49. Patients will receive different doses (50, 100, or 250 micrograms) along with 1mg of Litenimod.
  2. Phase 2a: This part will use the best dose determined in Phase 1 to further study the vaccine’s effectiveness and safety.

The main goals of the trial are to assess:

  • The safety of A49
  • The immune response triggered by the vaccine
  • How long patients live without their cancer getting worse (progression-free survival)
  • How long patients survive overall (overall survival)
  • The quality of life of patients receiving the treatment

Eligibility Criteria

To participate in the NAVIG-1 trial, patients must meet certain criteria[1]. Some key eligibility requirements include:

  • Age between 18 and 75 years old
  • Confirmed diagnosis of glioblastoma
  • Previous treatment with radiation therapy and chemotherapy (temozolomide)
  • Positive for a specific immune system marker (HLA-A2)
  • Presence of the PTPRZ1 protein in the tumor

There are also several factors that may exclude a patient from participating, such as certain medical conditions or previous treatments. It’s important to discuss eligibility with a healthcare provider.

Potential Benefits

While it’s too early to know the full benefits of A49, the vaccine is being studied with the hope that it may:

  • Stimulate the immune system to fight glioblastoma cells
  • Potentially slow down or stop the growth of glioblastoma tumors
  • Improve survival rates for patients with glioblastoma
  • Offer a new treatment option for a difficult-to-treat cancer

However, it’s important to remember that A49 is still in the experimental stages, and its effectiveness has not yet been proven[1].

Safety and Side Effects

One of the main goals of the NAVIG-1 trial is to assess the safety of A49. The researchers will be closely monitoring patients for any side effects or adverse reactions[1]. Side effects will be evaluated through:

  • Regular clinical check-ups
  • Blood tests
  • Brain scans (MRI)

As with any new treatment, there may be unknown risks and side effects. Patients in the trial will be closely monitored and should report any unusual symptoms to their healthcare team.

Aspect Details
Trial Name NAVIG-1: New adjuvant vaccine in glioblastoma
Phase 1/2a
Main Objective Assess maximum tolerated dose and immune response to A49
Key Eligibility Adults 18-75, confirmed glioblastoma, HLA-A2 positive
Treatment A49 peptide vaccine + Litenimod, subcutaneous injections
Primary Endpoints Safety and immune response at 2 months
Secondary Endpoints Progression-free survival, overall survival, quality of life
Follow-up Duration At least 12 months

FAQ

  • What is A49 and how does it work? A49 is a peptide vaccine associated with melanin, designed to stimulate the immune system to fight glioblastoma. It works by targeting specific proteins (PTPRZ1 and TERT) found in glioblastoma cells, potentially helping the body's immune system recognize and attack the cancer.
  • Who is eligible for this clinical trial? Eligible participants are adults aged 18-75 with confirmed glioblastoma who have completed initial treatment with radiation and chemotherapy. They must be HLA-A2 positive, have a Karnofsky Performance Status of 60% or higher, and meet other specific criteria outlined in the study.
  • How is A49 administered in this trial? A49 is administered through subcutaneous injections in the shoulders. The dosage will be determined in the Phase 1 part of the study, with three pre-specified dose levels being tested (50, 100, and 250 μg) along with a fixed dose of 1mg Litenimod.
  • What are the main goals of this clinical trial? The main objectives are to determine the safe dosage of A49, assess the immune response it generates, evaluate its safety profile, and measure outcomes such as progression-free survival and overall survival in glioblastoma patients.
  • How long does the trial last and what follow-up is involved? The trial involves regular follow-ups for at least 12 months. Participants will have clinical assessments, blood tests, and brain MRI scans at various time points throughout the study to monitor their progress and any potential side effects.

Ongoing Clinical Trials on A49

  • Study on A49, A52, and Litenimod Sodium for Patients with Glioblastoma

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Glioblastoma: An aggressive type of cancer that occurs in the brain or spinal cord, forming from cells called astrocytes that support nerve cells.
  • Adjuvant vaccine: A substance added to a vaccine to boost the body's immune response to the vaccine.
  • PTPRZ1: A protein found in certain brain cancers, including glioblastoma, which is targeted by the A49 vaccine.
  • TERT: Telomerase Reverse Transcriptase, an enzyme often overactive in cancer cells, which is also targeted by the A49 vaccine.
  • HLA-A2: A specific type of Human Leukocyte Antigen, which is important for the immune system's ability to recognize the vaccine.
  • Karnofsky Performance Status: A scale used to measure a cancer patient's general well-being and activities of daily life.
  • Progression-free survival: The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Overall survival: The length of time from the start of treatment that patients diagnosed with the disease are still alive.
  • ELISPOT: A laboratory technique used to measure immune responses by detecting cells that produce specific immune molecules.
  • Litenimod: A substance used in combination with A49 in this trial, likely to enhance the immune response.

References

  1. http://clinicaltrials.eu/trial/study-on-a49-a52-and-litenimod-sodium-for-patients-with-glioblastoma/