Not yet recruiting

Study on the Safety and Effects of YTB323, Tocilizumab, and Cyclophosphamide in Patients with Relapsing Multiple Sclerosis Who Have Active Disease Despite Treatment

Verified siteRegistered drugNo 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 Relapsing Multiple Sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The study will use a treatment called YTB323, which involves a type of cell therapy. This therapy uses a patient's own T cells, a type of white blood cell, that are modified to better recognize and attack certain cells in the body. The main goal of the study is to assess the safety of different doses of YTB323 in patients who have experienced disease activity despite previous treatments.

Participants in the study will receive YTB323 through an intravenous infusion, which means the treatment is delivered directly into the bloodstream. In addition to YTB323, some participants may also receive other medications such as Tocilizumab, Cyclophosphamide, and Fludarabine Phosphate, which are commonly used in medical treatments to manage immune responses and support the main therapy. The study will monitor the participants over time to observe any changes in their condition and to ensure the treatment is safe.

The trial will also involve regular check-ups, including tests like MRI scans, to track the progress of the disease and the effects of the treatment. The study aims to gather information on how the treatment affects the body and how well it works in managing the symptoms of Relapsing Multiple Sclerosis. This information will help in understanding the potential benefits and risks of using YTB323 for this condition.

The research process

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

Step 1
Initial assessment
The study begins with an initial assessment to confirm eligibility. This includes reviewing medical history and conducting various tests to ensure adequate kidney, liver, heart, blood, and lung function.
Participants must be between 18 and 55 years old and have a diagnosis of relapsing multiple sclerosis with recent disease activity.
Step 2
Pre-treatment phase
Before starting the main treatment, participants receive two medications: cyclophosphamide and fludarabine phosphate. These are administered through an intravenous infusion.
The purpose of these medications is to prepare the body for the main treatment.
Step 3
Main treatment
The main treatment involves the administration of YTB323, which is given as a single dose through an intravenous infusion.
The goal of this treatment is to assess its safety and how it behaves in the body.
Step 4
Monitoring phase
After receiving the main treatment, participants are closely monitored for any changes in health. This includes regular check-ups and tests to track safety and effectiveness.
Monitoring includes observing any side effects, changes in disease activity, and the body's response to the treatment.
Step 5
Follow-up
Participants continue to be monitored over time to gather long-term safety and effectiveness data.
This phase involves periodic visits and tests to ensure ongoing health and to collect data on the treatment's impact.

Who can join the trial?

6 criteria

Must sign an informed consent form and be able to communicate well with the study doctor and follow the study requirements.
Must have proper functioning of the kidneys, liver, heart, blood, and lungs.
Can be a male or female participant, aged between 18 and 55 years at the time of screening, with a diagnosis of Relapsing Multiple Sclerosis (RMS) according to specific criteria from 2017.
Must have had recent breakthrough disease activity within the last year, which means the disease has shown signs of worsening despite treatment.
Must be able to walk, with an EDSS score between 3 and 6, which is a scale used to measure disability in people with multiple sclerosis, assessed when not having a relapse.
The disease must have been present for less than 10 years.

Who cannot join the trial?

5 criteria

Patients who do not have Relapsing Multiple Sclerosis cannot participate. This is a condition where the immune system attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body.
Patients who are not experiencing breakthrough disease activity during previous treatment with highly effective therapy cannot participate. This means that the disease is still active despite being on strong medication.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Both male and female patients are eligible, so exclusion is not based on gender.
Patients who are not part of the vulnerable population may be excluded. Vulnerable populations include groups that may need special protection or consideration.

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Verified sites

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

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany

Trial locations

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Investigated drugs

YTB323 is an investigational therapy being studied for its safety and effectiveness in patients with Relapsing Multiple Sclerosis (RMS) who have experienced disease activity despite previous treatment with highly effective therapies. This study aims to understand how the body processes this therapy and its potential benefits for managing RMS.

What is already known about the treatment

YTB323 – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its safety and effectiveness in treating Relapsing Multiple Sclerosis, particularly in patients who have experienced disease activity despite previous treatments. YTB323 is designed to target and modify immune cells at the molecular level to reduce inflammation and prevent further nerve damage. It falls under the pharmacological classification of immunotherapy, which involves using the body's immune system to fight disease.

Investigated diseases

Relapsing Multiple Sclerosis – This is a chronic disease affecting the central nervous system, characterized by episodes of new or worsening neurological symptoms. These episodes, known as relapses, are followed by periods of partial or complete recovery. The disease can cause a wide range of symptoms, including fatigue, vision problems, muscle weakness, and difficulties with coordination and balance. Over time, relapses may lead to an accumulation of disability. The exact cause of relapsing multiple sclerosis is unknown, but it involves an abnormal immune response that damages the protective covering of nerve fibers. The progression of the disease varies greatly among individuals, with some experiencing frequent relapses and others having long periods of stability.