Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 safety and effects of a new treatment for people with Progressive Multiple Sclerosis (PMS), a condition where the immune system mistakenly attacks the protective covering of nerves, leading to worsening symptoms over time. The treatment being tested is called YTB323, which involves using a type of cell therapy. This therapy uses a patient's own immune cells, which are modified to better target and fight the disease. The study will also involve other medications, including Cyclophosphamide, Tocilizumab, and Fludarabine Phosphate, which are used to prepare the body for the cell therapy.

The purpose of the study is to assess the safety of different doses of YTB323 in patients with PMS. Participants will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will monitor participants over a period of time to observe any changes in their condition and to check for any side effects. This will help researchers understand how the treatment affects the disease and the body.

Throughout the study, participants will undergo various tests and procedures, such as blood tests and MRI scans, to track the progression of the disease and the body's response to the treatment. The study aims to gather important information that could lead to new treatment options for people living with PMS. The trial is expected to continue for several years to ensure comprehensive data collection and analysis.

The research process

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

  1. Step 1

    Initial visit

    Upon joining the study, you will have an initial visit where you will meet with the study team. During this visit, you will undergo various assessments to ensure you meet the study criteria. These assessments may include a review of your medical history, a physical examination, and tests such as blood draws and brain MRI scans.

  2. Step 2

    Pre-treatment phase

    Before starting the treatment, you will receive two medications: cyclophosphamide and fludarabine phosphate. These medications are given through an intravenous infusion, which means they are delivered directly into your bloodstream through a vein. The purpose of these medications is to prepare your body for the main treatment.

  3. Step 3

    Main treatment

    The main treatment involves the administration of YTB323, which is given through intravenous use. This is the primary medication being studied, and it is designed to assess its safety and effects on your condition.

  4. Step 4

    Monitoring phase

    After receiving the main treatment, you will enter a monitoring phase. During this time, you will have regular follow-up visits with the study team. These visits will include assessments to monitor your health and the effects of the treatment. You may undergo tests such as blood draws, brain MRI scans, and other evaluations to track your progress.

  5. Step 5

    Safety and progress evaluation

    Throughout the study, the safety of the treatment will be closely monitored. The study team will evaluate any side effects or adverse events you may experience. Additionally, your progress will be assessed to determine any changes in your condition.

  6. Step 6

    End of study

    The study is expected to last until June 2030. At the end of the study, you will have a final visit where the study team will conduct a comprehensive evaluation of your health and the overall effects of the treatment.

Who can join the trial?

6 criteria

  • Participants must be male or female and between 18 to 60 years old at the time of screening.
  • Participants must provide signed informed consent before joining the study. This means they agree to participate after understanding the study details.
  • Participants must be able to communicate well with the study team and understand what the study involves. This includes being able to undergo certain procedures like a lumbar puncture (LP), which is a procedure to collect fluid from the spine, and a brain MRI, which is a type of scan.
  • Participants must have a diagnosis of Secondary Progressive Multiple Sclerosis (SPMS) or Primary Progressive Multiple Sclerosis (PPMS) based on specific criteria confirmed during the screening visit.
  • The duration of the disease must be less than 15 years.
  • Participants must be ambulatory, meaning they can walk, with an EDSS score between 3 to 6.5 at screening. The EDSS is a scale used to measure the level of disability in people with multiple sclerosis.

Who cannot join the trial?

3 criteria

  • Patients with any other type of **Multiple Sclerosis** (MS) that is not **Non-active Progressive Multiple Sclerosis** (PMS) cannot participate. **Multiple Sclerosis** is a disease 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 to be within the required age group.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

YTB323 is a new type of treatment being studied for people with a condition called Progressive Multiple Sclerosis (PMS). This treatment involves using special cells from your own body that are changed in a lab to help fight the disease. The goal of this study is to see if YTB323 is safe for people with PMS and to understand how it works in the body. By using these modified cells, researchers hope to slow down the progression of the disease and improve the quality of life for patients. This study is important because it explores a new way to treat PMS, which currently has limited treatment options.

What is already known about the treatment

YTB323 – YTB323 is administered through an infusion, which means it is given directly into the bloodstream via a vein. This medication is currently being studied in clinical trials, specifically for its safety and effects in people with non-active Progressive Multiple Sclerosis (PMS). The main purpose of YTB323 is to help manage the progression of PMS, a condition where the disease gradually worsens over time without active inflammation. At the molecular level, YTB323 works by targeting specific cells in the immune system to help reduce the damage they cause to the nervous system. It is classified as an immunotherapy, which is a type of treatment that uses the body's own immune system to fight disease.

Investigated diseases

Progressive Multiple Sclerosis – Progressive Multiple Sclerosis is a form of multiple sclerosis characterized by a gradual worsening of neurological function over time. Unlike relapsing forms, it does not involve distinct relapses or remissions. The disease primarily affects the central nervous system, leading to symptoms such as muscle weakness, coordination problems, and cognitive difficulties. As the disease progresses, individuals may experience increased disability and a decline in physical and mental abilities. The progression rate can vary significantly among individuals, with some experiencing a slow decline and others a more rapid deterioration. The exact cause of the disease is not fully understood, but it involves immune system attacks on the protective covering of nerve fibers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514006-31-00Protocol codeCYTB323R12101Estimated enrolment23 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.