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Study on the Safety and Effectiveness of tolDC for Patients with Relapsing Remitting and Progressive Multiple Sclerosis

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 the disease known as Multiple Sclerosis (MS), which affects the brain and spinal cord, leading to a range of symptoms such as fatigue, difficulty walking, and vision problems. The treatment being tested in this study is called tolDC, which is a type of cell therapy. This treatment involves using special cells called dendritic cells, which are taken from the patient's own blood and modified outside the body to help the immune system work better. These cells are then injected back into the patient through a method called intradermal injection, which means the injection is given just under the skin.

The purpose of this study is to evaluate the safety and effectiveness of this new treatment in patients with two types of MS: Relapsing Remitting MS and Progressive MS. The study will involve patients receiving the tolDC treatment, while some may receive a placebo. The trial will monitor the number of new or growing lesions in the brain using MRI scans, which are detailed images of the brain, to see how well the treatment is working. Additionally, the study will track any side effects and changes in the frequency of relapses, which are periods when symptoms get worse.

Participants in the study will be observed over a period of time to assess changes in their condition, including any improvements in their symptoms or overall health. The study aims to provide valuable information on whether tolDC can be a safe and effective treatment option for people living with Multiple Sclerosis. The trial is expected to continue until 2027, with recruitment starting in 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis of Multiple Sclerosis (MS), and ability to comply with the protocol.
Participants must have appropriate venous access and agree to use adequate contraceptive measures if of reproductive potential.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health status, including a review of medical history and a physical examination.
MRI scans are performed to evaluate the presence of new or enlarging T2 lesions, which are areas of damage in the brain.
Step 3
Treatment administration
Participants receive the treatment, which involves an intradermal injection of myelin peptide-loaded tolDC.
The treatment is administered according to a schedule determined by the study protocol.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor the participant's health and response to the treatment.
MRI scans are repeated to assess changes in T2 lesions and other brain structures.
Step 5
Evaluation of outcomes
The primary outcome is evaluated by the number of new and enlarging T2 lesions on MRI scans.
Secondary outcomes include the number and severity of adverse events, proportion of relapse-free patients, and changes in relapse rate and disability scores.
Step 6
Completion of the study
The study is estimated to conclude by October 2027.
Final assessments are conducted to determine the overall efficacy and safety of the treatment.

Who can join the trial?

12 criteria

Have a diagnosis of **Multiple Sclerosis (MS)** according to the most recent guidelines.
Be able to follow the study's procedures and assessments.
Have suitable veins for blood tests and treatments.
Use effective birth control methods during the study if you can have children. This applies to both men and women. Accepted methods include hormonal contraceptives (like pills or patches), intrauterine devices, sterilization, being postmenopausal, or using condoms with spermicide.
Be between 18 and 60 years old.
Have a score between 0 and 6.0 on the **Expanded Disability Status Scale (EDSS)**, which measures disability in MS.
Have **active MS**, meaning at least one relapse in the past year, or at least one new or growing lesion on a brain scan in the past year.
Be either on first-line treatment for MS or not receiving treatment due to side effects or personal choice.
Have no MS relapse in the month before starting the study and during the initial screening phase.
Have a normal total count of **lymphocytes**, which are a type of white blood cell.
Have a normal count of **peripheral B cells**, another type of white blood cell.
Be able to understand and sign a consent form agreeing to participate in the study.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with **Multiple Sclerosis** cannot participate. **Multiple Sclerosis** is a condition that affects the brain and spinal cord.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, like children or people with certain disabilities.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
Verified
Badalona, Spain
University Of Antwerp
Verified
Edegem, Belgium

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Investigated drugs

Myelin Peptide-Loaded tolDC is an experimental therapy being tested for its safety and effectiveness in treating Multiple Sclerosis (MS). This therapy involves using dendritic cells (tolDC) that are loaded with myelin peptides. These cells are specially prepared in a laboratory following strict manufacturing standards. The goal is to help the immune system better manage the disease by potentially reducing the frequency and severity of MS relapses and slowing down disease progression.

Toldc

What is already known about the treatment

Myelin Peptide-Loaded TolDC – This medication is administered through injection, specifically designed for patients with Multiple Sclerosis. It is currently being evaluated in a phase II clinical trial to determine its safety and effectiveness. The main therapeutic indication is for treating Relapsing Remitting and Progressive forms of Multiple Sclerosis. The medication works by using dendritic cells that are loaded with myelin peptides, aiming to modulate the immune system's response to reduce inflammation and prevent further damage to nerve cells. It falls under the pharmacological classification of immunomodulatory therapies.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system mistakenly attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms can vary widely, depending on the amount of nerve damage and which nerves are affected, and may include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The disease often progresses with periods of relapses and remissions, or it may steadily worsen over time. There are different types of Multiple Sclerosis, including Relapsing-Remitting and Progressive forms, each with its own pattern of progression.