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Study of the safety and effectiveness of tolDC therapy in patients with progressive forms of multiple sclerosis

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What is this trial about?

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

This study focuses on individuals living with progressive forms of Multiple Sclerosis, a condition that affects the central nervous system. The research aims to evaluate the safety and effectiveness of a treatment called tolDC. This therapy involves using tolerogenic dendritic cells, which are specialized immune cells that are modified to help the body stop attacking its own healthy tissues. These cells are prepared using vitamin D3 and pieces of myelin, which is the protective coating around nerve fibers that is often damaged in this disease.

The treatment is administered through an intradermal injection, which is an injection delivered into the skin. During the course of the study, participants will undergo various assessments to monitor how they respond to the therapy. This includes regular neurological examinations and the use of MRI to look for changes in the brain, such as new or growing lesions, which are areas of damage. Additionally, blood samples may be collected to measure specific biomarkers, which are natural substances in the body that provide information about the state of the disease and how the body is reacting to the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>administration of tolDC</b>

    An injection of tolDC, which consists of specialized immune cells treated with vitamin D3 and loaded with myelin-derived peptides (small pieces of proteins from the protective coating of nerves), is received through the skin (intradermal injection).

    The dose provided is 15,000,000 units of the substance.

  2. Step 2

    <b>safety and disability monitoring</b>

    The safety and how well the body tolerates the treatment are monitored by recording any side effects or unexpected medical events throughout the trial.

    The impact on disability is measured by tracking changes in the expanded disability severity scale (EDSS), which is a tool used to assess physical function.

  3. Step 3

    <b>neurological and cognitive assessments</b>

    Neurological examinations are conducted, including the 9-HPT to check hand dexterity (skill in using the hands) and the SDMT to evaluate cognitive performance (mental processing speed).

    The progression of disability is analyzed to see if the condition remains stable.

  4. Step 4

    <b>imaging and laboratory tests</b>

    MRI scans are used to monitor brain volume, brain shrinkage (atrophy), and the presence of any new or growing lesions (areas of damage) in the brain.

    Blood samples are taken to measure biomarkers, specifically neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), which are substances in the blood that provide information about nerve health.

    Immune profiling is performed using blood cells (PBMCs) and serum or plasma (the liquid part of the blood) collected at specific times to study changes in the immune system.

  5. Step 5

    <b>symptom and quality of life reporting</b>

    Pain levels are reported using a visual analog scale (VAS), which is a tool used to measure the intensity of pain.

    Quality of life is measured using the EQ-5D-5L questionnaire.

Who can join the trial?

8 criteria

  • You must be between 18 and 65 years old at the time of the first screening visit.
  • You must have a confirmed diagnosis of Multiple Sclerosis (a condition affecting the central nervous system) based on specific medical standards known as the McDonald Criteria.
  • You must have a progressive form of the disease, meaning the condition worsens over time without distinct periods of recovery.
  • Your disability level, measured by the Expanded Disability Severity Scale (EDSS)—which is a scale used to measure how much the disease affects your ability to walk and function—must be between 2.0 and 7.5.
  • You must not have had any relapses (sudden increases in symptoms or new neurological problems) in the last 2 years.
  • You must be able to understand the study details and be willing to sign a written informed consent document, which is a formal paper stating you agree to participate after being fully informed.
  • You must have appropriate venous access, meaning you have veins that are suitable for medical procedures like blood draws or giving medication.
  • You must use effective birth control or not be at a stage in life where you can become pregnant.

Who cannot join the trial?

13 criteria

  • You have used certain medications, such as alemtuzumab, autologous hematopoietic stem cell transplantation (a procedure where a person's own blood-forming stem cells are collected and then returned to the body), or cladribine within the last 3 years.
  • You have an active or long-term infection with hepatitis B, hepatitis C, HIV (a virus that attacks the body's immune system), syphilis, or tuberculosis.
  • You have had a splenectomy, which is the surgical removal of the spleen.
  • You have dementia (a decline in mental ability) or severe issues with mental health, thinking, or behavior that might make it difficult to follow the study rules.
  • You have taken any experimental medicine within the last 3 months, or within a timeframe determined by how long the medicine stays in your body (known as 5 half-lives).
  • You are currently taking an approved DMT (disease-modifying therapy), which is a medicine used to change the course of multiple sclerosis.
  • You have used specific medicines like S1P receptor modulators, natalizumab, dimethylfumarate, or teriflunomide within the last 3 months.
  • You have used B cell depleting monoclonal antibodies (medicines that reduce certain immune cells) within the last 6 months, or if your CD19 B cell counts (a measure of specific immune cells in your blood) are not normal.
  • You are pregnant, breastfeeding, or planning to become pregnant within the next 12 months.
  • You have a history of drug or alcohol abuse.
  • You are unable to undergo an MRI (a medical imaging test that uses strong magnets to create detailed pictures of the inside of the body).
  • You have a history of or current signs of immunodeficiency (a weakened immune system) or malignancies (cancer), unless it is a treated basal cell carcinoma (a common, slow-growing type of skin cancer).
  • You have other major health problems involving the heart, immune system, lungs, nervous system, or kidneys that could affect your safety or the results of the study.
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Investigated drugs

tolDC is a specialized cell therapy made from the patient's own immune cells. These cells are treated with vitamin D3 and loaded with specific pieces of myelin (the protective coating around nerve cells) to help train the immune system to stop attacking the nervous system in people with progressive multiple sclerosis.

What is already known about the treatment

tolDC - This experimental treatment is administered through an injection into the skin to help manage progressive multiple sclerosis. It consists of specialized immune cells that have been treated with vitamin D3 and loaded with specific proteins from the body's nerve coating to teach the immune system to stop attacking itself. Currently, this substance is being studied in clinical trials to determine if it is safe and effective for patients. This therapy is classified as a cell-based immunotherapy that works by calming an overactive immune response at the cellular level.

Investigated diseases

Multiple Sclerosis - This is a condition where the body's immune system attacks the protective covering that surrounds nerve cells in the brain and spinal cord. This process causes damage to the nerves and disrupts the communication signals between the brain and the rest of the body. As the condition progresses, it can lead to a steady increase in physical disability. It often involves various neurological changes that affect movement and coordination. The progression can occur in different patterns, including stages where symptoms worsen over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522040-40-01Estimated enrolment14 patientsSponsorAntwerp University Hospital

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).