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Study of WT1 LAMP mRNA DC Vaccine for Patients with Malignant Pleural Mesothelioma

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called Malignant Pleural Mesothelioma, which is a type of cancer that affects the lining of the lungs. The treatment being tested is a new form of immunotherapy using a vaccine called WT1 LAMP mRNA DC. This vaccine is made from special cells called dendritic cells, which are modified to target a protein known as Wilms' tumor 1 (WT1). The vaccine is given as an injection under the skin.

The purpose of the study is to see if this new vaccine is safe and can be used effectively as a first treatment for patients with Malignant Pleural Mesothelioma, alongside standard chemotherapy. Participants in the study will receive the vaccine and chemotherapy over a period of time. The study will monitor how well the vaccine is tolerated and whether it can be successfully produced and administered.

Throughout the study, researchers will also look at how the disease responds to the treatment, including how long it takes for the disease to progress and how long patients live without the disease getting worse. Additionally, the study will examine the body's immune response to the vaccine to understand if it helps the immune system fight the cancer more effectively.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and medical history.

    Written informed consent is required before participation.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate overall health and readiness for the trial.

    This includes a review of medical history and current health status.

  3. Step 3

    Leukapheresis procedure

    A procedure called leukapheresis is performed to collect white blood cells.

    These cells are used to prepare the WT1 LAMP mRNA DC vaccine.

  4. Step 4

    Vaccine preparation

    The collected cells are processed to create the WT1 LAMP mRNA DC vaccine.

    At least four doses of the vaccine are prepared for administration.

  5. Step 5

    Vaccine administration

    The vaccine is administered through intradermal injection.

    This is done in combination with standard chemotherapy.

  6. Step 6

    Monitoring and follow-up

    Regular monitoring is conducted to assess safety and any side effects.

    This includes clinical laboratory tests and reporting of any adverse events.

  7. Step 7

    Evaluation of treatment response

    The effectiveness of the treatment is evaluated through various clinical endpoints.

    This includes measuring time to progression, progression-free survival, and overall survival.

  8. Step 8

    Immunological response analysis

    An analysis is performed to evaluate the immune response to the vaccine.

    This helps determine the development of effective anti-mesothelioma immunity.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of **epithelial Malignant Pleural Mesothelioma (MPM)**, which is a type of cancer affecting the lining of the lungs.
  • Must be **18 years or older** at the time of joining the study.
  • Must have a **WHO performance status of 0-1**, which means the patient is fully active or has some symptoms but can carry out light work.
  • Must be able to undergo **general anesthesia**, which is a type of medicine that makes you sleep during surgery, and other procedures like **thoracoscopy** (a procedure to look inside the chest), **leukapheresis** (a procedure to collect white blood cells), **chemotherapy**, **immunotherapy**, and possibly **P/D** (a surgery to remove part of the lung lining if the disease can be operated on).
  • Must not have received any **investigational treatment** (experimental treatment) within 28 days before joining the study.
  • Must not have a history of being unable to tolerate **pemetrexed** and/or **cisplatin**, which are types of chemotherapy drugs.
  • Must provide **written informed consent** before joining the study, which means agreeing to participate after being fully informed about the study, according to international and local rules.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than Malignant Pleural Mesothelioma cannot participate. This is a specific type of cancer that affects the lining of the lungs.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not able to receive the standard chemotherapy treatment cannot participate. This is a common cancer treatment that uses drugs to kill cancer cells.
  • Patients who have any medical condition that makes it unsafe for them to receive the study treatment cannot participate. This is to ensure the safety of all participants.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate. This is important for the accuracy and success of the study.
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Investigated drugs

  • Wilms' tumor 1 mRNA-electroporated dendritic cell vaccinations

    This therapy involves using a type of immune cell called dendritic cells that have been modified with a specific mRNA. The mRNA is related to the Wilms' tumor protein 1, which is often found in certain cancer cells. The goal of this vaccination is to help the immune system recognize and attack cancer cells in patients with malignant pleural mesothelioma.

  • Standard chemotherapy

    This refers to the usual treatment using drugs that kill or stop the growth of cancer cells. In this trial, standard chemotherapy is used in combination with the dendritic cell vaccinations to treat malignant pleural mesothelioma.

What is already known about the treatment

Wilms' Tumor 1 mRNA-electroporated Dendritic Cell Vaccine – This medication is administered as a vaccine, specifically designed to target the Wilms' tumor protein 1 in patients with malignant pleural mesothelioma. It is currently being studied in clinical trials to assess its feasibility and safety when used as a first-line treatment in combination with standard chemotherapy. The main therapeutic indication is for malignant pleural mesothelioma, a type of cancer affecting the lining of the lungs. The vaccine works by using dendritic cells that have been modified with mRNA to stimulate the immune system to recognize and attack cancer cells expressing the Wilms' tumor protein 1. It falls under the pharmacological classification of immunotherapy, which aims to enhance the body's natural defenses to fight cancer.

Investigated diseases

Malignant Pleural Mesothelioma – This is a rare and aggressive cancer that affects the lining of the lungs, known as the pleura. It is primarily caused by exposure to asbestos fibers, which can lead to inflammation and scarring over time. The disease progresses as cancerous cells form in the pleura, leading to thickening and fluid buildup, which can cause breathing difficulties and chest pain. As the cancer advances, it may spread to other parts of the body, including the chest wall, diaphragm, and nearby organs. The progression of malignant pleural mesothelioma can vary, with some individuals experiencing rapid advancement while others may have a slower course. Early detection is challenging due to the disease's nonspecific symptoms and long latency period.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517970-35-00Protocol codeMESODECEstimated enrolment30 patientsSponsorAntwerp University Hospital

sourced from the EU Clinical Trials Register and site verification

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