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Study on the Safety and Effectiveness of TolDec and Immunotherapy for Patients with Relapsing-Remitting 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 Multiple Sclerosis (MS), a condition that affects the brain and spinal cord, leading to a range of symptoms such as vision problems, difficulty walking, and fatigue. The study is testing a new treatment called TolDec, which involves the use of autologous tolerogenic dendritic cells. These are special cells taken from the patient's own body and modified to help the immune system function better. The treatment is given as a solution for injection directly into the bloodstream.

The purpose of this study is to evaluate how effective and safe TolDec is when used alongside standard first-line immunotherapy treatments for people with a type of MS known as Relapsing-Remitting Multiple Sclerosis (RRMS). These standard treatments may include medications like interferon beta or glatiramer acetate. The study will monitor changes in the brain using imaging techniques and track any side effects experienced by participants.

Participants in the study will receive the TolDec treatment over a period of three months. During this time, they will have regular check-ups to assess the treatment's impact on their condition and to ensure their safety. Some participants may receive a placebo instead of the active treatment to help compare the results. The study aims to provide valuable information on whether this new approach can improve outcomes for people living with MS.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of relapsing-remitting multiple sclerosis (RRMS), and disease duration.

    The assessment also checks the expanded disability status scale (EDSS) score, which should be between 0 and less than 5.5.

    A review of previous treatments and relapses is performed to ensure eligibility for the study.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is conducted to establish initial health status. This includes a magnetic resonance imaging (MRI) scan to identify any new or persisting lesions.

    A pregnancy test is required for women of child-bearing potential, and effective contraceptive methods must be agreed upon for the study duration.

  3. Step 3

    Treatment administration

    The treatment involves the administration of TolDec, a solution for injection containing autologous tolerogenic dendritic cells.

    The solution is administered intravenously, in combination with first-line immunomodulatory treatments such as interferon beta 1a, interferon beta 1b, glatiramer acetate, teriflunomide, or dimethyl fumarate.

    The frequency and dosage of TolDec are determined by the study protocol and are administered under medical supervision.

  4. Step 4

    Follow-up evaluations

    Follow-up evaluations are conducted at weeks 12, 18, and 24 to monitor changes in the number of lesions and assess the efficacy of the treatment.

    Safety assessments are performed to identify any adverse events related to the treatment.

  5. Step 5

    Completion of study

    The study is estimated to conclude by December 31, 2025.

    Final assessments are conducted to evaluate the overall efficacy and safety of the treatment.

Who can join the trial?

14 criteria

  • Age between 18-65 years old.
  • Diagnosed with **RRMS** (Relapsing-Remitting Multiple Sclerosis) according to specific guidelines from 2017.
  • Have had **MS** (Multiple Sclerosis) for less than 10 years.
  • Have a score on the **Expanded Disability Status Scale (EDSS)** between 0 and less than 5.5. This scale measures disability in people with MS.
  • Eligible to start or already receiving first-line **immunomodulatory treatment**. This includes medications like interferon beta 1a, interferon beta 1b, glatiramer acetate, teriflunomide, or dimethyl fumarate.
  • Experienced one or more relapses in the 2 years before the study screening. This includes either:
    • One relapse in the last year before the study screening.
    • Presence of one or more new lesions in the brain as seen on an **MRI** (Magnetic Resonance Imaging) scan in the last 12 months.
    • Able to sign an informed consent form, which means understanding and agreeing to participate in the study.
    • Women who can have children must have a negative pregnancy test before joining the study and agree to use highly effective birth control methods during the study. These methods include:
      • Hormonal contraception that stops ovulation (oral, intravaginal, transdermal).
      • Progestogen-only hormonal contraception that stops ovulation (oral, injectable, implantable).
      • Intrauterine device (IUD).
      • Bilateral tubal occlusion (blocking of the fallopian tubes).
      • Partner with a vasectomy.
      • Sexual abstinence (not having sexual intercourse).

Who cannot join the trial?

5 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 receiving first-line immunotherapy for RRMS cannot participate. Immunotherapy is a treatment that helps the immune system fight diseases. RRMS stands for Relapsing-Remitting Multiple Sclerosis, a type of multiple sclerosis where symptoms flare up and then improve.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial group cannot participate. The specific group is not detailed here, but it is a requirement for the study.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection or care.
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Investigated drugs

  • TolDec

    is a therapy that uses dendritic cells, which are a type of immune cell. In this trial, TolDec is being tested to see how well it works and how safe it is when used with other treatments for multiple sclerosis. Dendritic cells help the immune system recognize and fight off harmful substances, and this therapy aims to improve the body's ability to manage multiple sclerosis.

  • First Line Immunotherapy

    refers to the initial treatment given to patients with multiple sclerosis to help manage their symptoms and slow the progression of the disease. These therapies work by modifying the immune system's response to reduce inflammation and prevent further damage to the nervous system. The specific medications used in first line immunotherapy can vary, but they are generally well-established treatments for managing multiple sclerosis.

What is already known about the treatment

TolDec – This medication is administered through an injection, typically under the skin. It is currently being studied in clinical trials for its potential use in treating multiple sclerosis, specifically in combination with other immunomodulatory treatments. The main therapeutic indication for TolDec is to help manage relapsing-remitting multiple sclerosis (RRMS). At the molecular level, TolDec works by modulating the immune system, potentially reducing inflammation and preventing immune cells from attacking the nervous system. It is classified as an immunomodulatory agent.

Investigated diseases

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It occurs when the immune system mistakenly attacks the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, this can cause permanent damage or deterioration of the nerves themselves. Symptoms can vary widely, including fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The disease often progresses with periods of new symptoms or relapses that can last for days or months, followed by periods of remission. The progression and severity of symptoms can differ greatly among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519975-24-00Protocol codeTolDec-COMBINEMEstimated enrolment45 patientsSponsorFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

sourced from the EU Clinical Trials Register and site verification

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