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AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS

Clinical trials of AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS are studying this treatment in people with multiple sclerosis, especially relapsing-remitting multiple sclerosis (RRMS). The main goals are to check whether it helps control disease activity and whether it is safe when used with first-line immunotherapy.

Table of contents

Trial overview

The available trial data describe one interventional study of AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS in multiple sclerosis.[1] The study title says it was a dendritic cell therapy combined treatment in multiple sclerosis, and the brief summary says it tested TolDec together with first-line immunotherapy in RRMS patients.[1]

Who was studied

The target population was people with relapsing-remitting multiple sclerosis (RRMS).[1] RRMS is a form of multiple sclerosis where symptoms can come and go in attacks, with periods of improvement between them.

The trial record does not provide extra details about age limits, sex, or other entry rules.[1]

What was tested

The study tested TolDec, listed as a drug intervention given intravenously, meaning through a vein.[1] The trial also studied TolDec in combination with first-line immunotherapy, so the researchers were looking at the treatment as part of a combined approach.[1]

The source data do not give more detail about the treatment plan beyond the intervention name and route of administration.[1]

What researchers measured

The main efficacy outcome was the change from baseline in the number of CUA lesions at weeks 12, 18, and 24.[1] A CUA lesion was defined in the trial as a new or persisting gadolinium-enhancing lesion on T1 MRI, or a new or enlarging lesion on T2 MRI.[1]

In simple terms, the researchers used brain MRI scans to see whether there were fewer signs of active or new disease over time.[1]

The safety outcomes focused on the proportion of patients with any Grade 3-4 adverse events related to product administration and related to the study product.[1] Grade 3-4 adverse events are serious or severe medical problems recorded during the study.[1]

Trial phase and status

This was a Phase 2 trial.[1] Phase 2 studies are usually designed to look more closely at early signs that a treatment may help, while also continuing to monitor safety.

The study status is completed, which means the trial has finished.[1] The enrollment was 45 participants.[1]

What the trial data show

Based on the provided record, the main research question was whether AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS, used with first-line immunotherapy, could reduce MRI signs of disease activity in RRMS.[1] The trial also aimed to learn whether serious treatment-related side effects occurred during the study period.[1]

Because only one completed study is listed here, the data give a focused view of early clinical research rather than a full picture of all possible uses.[1]

Trial ID Phase Condition studied Status Enrollment
2024-519975-24-00 Phase 2 Multiple sclerosis Completed 45

FAQ

  • What condition is being studied with AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS? The trial data show one study in multiple sclerosis, specifically RRMS. It looks at disease activity on brain MRI and safety during treatment.
  • Who was able to take part in the trial? The study focused on patients with RRMS. The trial summary does not give more details about age, sex, or other entry rules.
  • What phase is the trial? The trial is Phase 2. This means it is an early study that looks more closely at whether the treatment may work and how safe it is.
  • What did the researchers measure? They measured changes in the number of CUA lesions on MRI and checked for serious side effects. CUA lesions are new or changing brain lesions seen on MRI scans.
  • Is the trial still ongoing? No. The trial status is completed. That means the study has already finished collecting its results.

Ongoing Clinical Trials on AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS

  • Study on the Safety and Effectiveness of TolDec and Immunotherapy for Patients with Relapsing-Remitting Multiple Sclerosis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Multiple sclerosis: A long-term disease where the immune system attacks the brain and spinal cord, which can cause problems with movement, vision, balance, and other functions.
  • Relapsing-remitting multiple sclerosis (RRMS): A type of multiple sclerosis where symptoms can flare up, then improve for a time.
  • Interventional study: A clinical trial where researchers give a treatment and then measure what happens.
  • Phase 2: A trial stage that helps researchers learn more about early signs of benefit and safety.
  • MRI: A scan that uses magnets and radio waves to make detailed pictures of the inside of the body, including the brain.
  • Gadolinium-enhancing lesion: An area that lights up on MRI after contrast dye is given, which can show active inflammation.
  • T2 lesion: An area seen on a type of MRI image that can show damage or disease activity.
  • Adverse event: A medical problem that happens during a study. It may or may not be caused by the treatment.
  • Grade 3-4 adverse event: A serious or severe side effect. Grade 3 is severe, and Grade 4 is life-threatening.
  • Efficacy: How well a treatment works.
  • First-line immunotherapy: The first treatment used to control the immune system disease.

References

  1. https://clinicaltrials.gov/study/2024-519975-24-00