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A52

A new clinical trial is underway to investigate the potential of A52, a peptide-based vaccine, in treating glioblastoma, an aggressive form of brain cancer. This study, known as NAVIG-1, aims to evaluate the safety and effectiveness of A52 when combined with other treatments. The trial focuses on patients who have already undergone initial therapy and seeks to improve their outcomes through this innovative approach.

Table of Contents

What is A52?

A52 is a new experimental treatment being studied for patients with glioblastoma, which is a type of aggressive brain cancer[1]. It is classified as an adjuvant vaccine, which means it’s designed to help boost the body’s immune response against cancer cells. A52 is also referred to as “Peptide A52 associated to melanin” in medical terms[1].

How A52 Works

A52 is part of a new approach to treating glioblastoma. It works by targeting specific proteins found in glioblastoma cells, namely PTPRZ1 and TERT[1]. The vaccine is designed to stimulate the patient’s immune system, particularly T cells, to recognize and attack cancer cells that express these proteins. This approach is known as immunotherapy, which harnesses the power of the body’s own immune system to fight cancer.

Clinical Trial Details

A52 is currently being studied in a clinical trial called NAVIG-1, which stands for “New adjuvant vaccine in glioblastoma”[1]. This is a Phase 1/2a study, which means it’s in the early stages of testing in humans. The main goals of this study are:

  • To find the safest and most effective dose of A52 (Phase 1)
  • To see how well A52 stimulates the immune system against glioblastoma (Phase 2a)
  • To assess how safe A52 is for patients
  • To measure how long patients live without their cancer getting worse (progression-free survival)
  • To measure how long patients survive overall (overall survival)
  • To evaluate patients’ quality of life during treatment

Eligibility Criteria

Not all glioblastoma patients can participate in this study. Some key eligibility criteria include[1]:

  • Age between 18 and 75 years old
  • Confirmed diagnosis of glioblastoma
  • Previous treatment with radiation therapy and chemotherapy (temozolomide)
  • Good overall health status (Karnofsky Performance Status ≥ 60%)
  • Positive for a specific immune system marker (HLA-A2)
  • Presence of the PTPRZ1 protein in the tumor

There are also several factors that would exclude a patient from participating, such as pregnancy, certain medical conditions, or previous treatments that might interfere with the study.

Treatment Process

In this clinical trial, A52 is given as a subcutaneous injection, which means it’s injected just under the skin in the shoulder area[1]. The treatment is given along with another substance called Litenimod, which helps boost the immune response. Patients receive multiple injections over the course of several months, with regular check-ups and tests to monitor their progress and any side effects.

Potential Benefits

While it’s important to remember that A52 is still experimental, researchers hope it could offer several potential benefits for glioblastoma patients[1]:

  • Stimulate the immune system to fight glioblastoma cells
  • Potentially slow down or stop the growth of the tumor
  • Possibly extend the time patients live without their cancer getting worse
  • Potentially improve overall survival

Safety and Side Effects

As with any new treatment, safety is a top priority in this study. Researchers will closely monitor patients for any side effects or adverse reactions[1]. Common side effects of cancer vaccines can include pain or swelling at the injection site, fever, and flu-like symptoms. However, the specific side effects of A52 are still being studied.

It’s important to note that participating in a clinical trial involves risks, and A52 may not work for everyone. Patients considering this treatment should discuss the potential risks and benefits thoroughly with their healthcare team.

Aspect Details
Trial Name NAVIG-1: New adjuvant vaccine in glioblastoma
Trial Phase Phase 1/2a
Main Objective Assess maximum tolerated dose and immune responses to A52 vaccine
Key Eligibility Adults 18-75, confirmed glioblastoma, HLA-A2 positive, completed initial therapy
Treatment A52 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 A52 and how does it work? A52 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 radiation therapy and chemotherapy. They must be HLA-A2 positive, have a Karnofsky Performance Status of 60% or higher, and meet other specific health criteria.
  • How is the A52 vaccine administered? The A52 vaccine is given through subcutaneous injections in the shoulders. The dosage will be determined during the trial, with Phase 1 testing different dose levels to find the most effective and safe amount.
  • What are the main goals of this clinical trial? The primary goals are to determine the safe dosage of A52, assess its ability to trigger specific immune responses against the cancer, and evaluate its impact on patients' survival and quality of life.
  • How long does the trial last and what follow-up is involved? The trial involves regular check-ups and tests over at least 12 months. Participants will undergo blood tests, brain MRI scans, and quality of life assessments at various time points to monitor their progress and the vaccine's effects.

Ongoing Clinical Trials on A52

  • 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.
  • PTPRZ1: A protein found in glioblastoma cells that the A52 vaccine targets to stimulate an immune response.
  • TERT: Another protein found in glioblastoma cells that the A52 vaccine targets to stimulate an immune response.
  • HLA-A2: A specific type of human leukocyte antigen (HLA) that patients must have to be eligible for this trial.
  • Karnofsky Performance Status: A scale used to measure a cancer patient's general well-being and activities of daily life.
  • Subcutaneous injection: An injection given just under the skin, which is how the A52 vaccine is administered.
  • Phase 1/2a trial: An early stage of clinical research that focuses on finding the right dose and assessing initial effectiveness of a new treatment.
  • Maximum Tolerated Dose (MTD): The highest dose of a treatment that does not cause unacceptable side effects.
  • Progression-free survival: The length of time during and after treatment that a patient lives without the cancer getting worse.
  • RANO 2.0 criteria: A set of guidelines used to assess the response to treatment in brain tumors.
  • EORTC QLQ30 and BN20: Questionnaires used to assess the quality of life in cancer patients, specifically those with brain tumors.
  • Litenimod: A substance given along with the A52 peptide in the vaccine to enhance its effects.
  • IFN-gamma ELISPOT: A laboratory test used to measure specific immune responses triggered by the vaccine.

References

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