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Study on the Safety and Effects of Rapcabtagene Autoleucel, Tocilizumab, Fludarabine Phosphate, and Cyclophosphamide for Patients with Rheumatoid Arthritis and Sjogren's Disease

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 two challenging diseases: rheumatoid arthritis and Sjögren's disease. Rheumatoid arthritis is a condition where the immune system mistakenly attacks the joints, causing pain and swelling. Sjögren's disease is another immune system disorder that primarily affects the glands that produce tears and saliva, but in severe cases, it can involve other organs. The study will explore the effects of a new treatment called rapcabtagene autoleucel, also known by its code name YTB323. This treatment is a type of cell therapy, which involves using specially modified cells to target and treat the disease.

The purpose of the study is to assess the safety of rapcabtagene autoleucel in participants with difficult-to-treat rheumatoid arthritis and severe, refractory Sjögren's disease with organ involvement. Participants will receive the treatment through an intravenous infusion, which means it will be administered directly into the bloodstream. The study will also involve monitoring the behavior of the treatment in the body, known as cellular kinetics, to understand how it moves and changes over time.

In addition to rapcabtagene autoleucel, the study will also involve the use of other medications, including tocilizumab, fludarabine phosphate, and cyclophosphamide. These medications are commonly used in treating autoimmune diseases and will be administered as part of the study protocol. Some participants may receive a placebo instead of the active treatment. The study aims to gather information over a period of time to evaluate the treatment's safety and its potential effectiveness in managing these complex diseases.

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 visit

    Upon joining the study, you will have an initial visit. During this visit, your medical history will be reviewed, and a physical examination will be conducted. This is to ensure that you meet the study's criteria.

    You will be informed about the study procedures, and any questions you have will be answered. You will also be asked to sign a consent form to confirm your participation.

  2. Step 2

    Pre-treatment assessment

    Before starting the treatment, several assessments will be conducted. These include blood tests, vital signs measurement, and an electrocardiogram (ECG) to check your heart's activity.

    These assessments help in establishing a baseline for your health status before the treatment begins.

  3. Step 3

    Treatment phase

    The treatment involves receiving medications through an intravenous (IV) infusion. The medications include tocilizumab, fludarabine phosphate, cyclophosphamide, and rapcabtagene autoleucel.

    The exact dosage, frequency, and duration of each medication will be explained to you by the study team. The treatment aims to assess the safety and effects of these medications on your condition.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring will be conducted to assess your health and the effects of the treatment. This includes repeated blood tests, vital signs checks, and ECGs.

    You will be asked to report any side effects or changes in your health. This information is crucial for evaluating the safety of the treatment.

  5. Step 5

    End of study visit

    At the end of the study, a final visit will be scheduled. During this visit, a comprehensive assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

    You will have the opportunity to discuss your experience and any concerns with the study team.

Who can join the trial?

7 criteria

  • Must provide a signed informed consent before joining the study.
  • Must be a man or woman aged between 18 and 65 years at the time of screening.
  • For those with Difficult to treat rheumatoid arthritis (D2T RA):
    • Must have a diagnosis of rheumatoid arthritis.
    • Must have experienced treatment failure with standard therapies.
    • Must show signs of active and progressive disease.
    • For those with Severe, refractory Sjogren’s disease (srSjD):
      • Must have a diagnosis of Sjogren’s disease.
      • Must have severe systemic disease that is difficult to treat, with moderate to high disease activity.

Who cannot join the trial?

2 criteria

  • Patients with **severe, refractory Sjogren’s disease** that affects organs cannot participate. This means the disease is very serious and does not respond to treatment.
  • Patients with **difficult to treat rheumatoid arthritis** are excluded. This refers to a type of arthritis that is hard to manage with standard treatments.
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Investigated drugs

Rapcabtagene autoleucel is a type of therapy that uses your own immune cells to help fight diseases like rheumatoid arthritis and Sjogren's disease. In this treatment, some of your immune cells are taken from your body and modified in a lab to better recognize and attack the cells causing your disease. After this modification, the cells are put back into your body to help reduce symptoms and improve your condition. This therapy is being studied to see how safe it is and how well it works for people with difficult-to-treat rheumatoid arthritis and severe Sjogren's disease that affects organs.

What is already known about the treatment

Rapcabtagene autoleucel – This medication is administered through an infusion, which means it is given directly into the bloodstream. It is currently being studied in clinical trials to determine its safety and effectiveness for treating severe, hard-to-treat conditions like Sjogren’s disease with organ involvement and rheumatoid arthritis. The medication works by modifying certain cells in the body to help them better fight these diseases. It belongs to a class of treatments known as gene therapies, which aim to correct or modify genetic issues to improve health.

Investigated diseases

  • Sjogren's Syndrome

    Sjogren's Syndrome is an autoimmune disorder characterized by the body's immune system attacking its own moisture-producing glands. This leads to symptoms such as dry mouth and dry eyes. In severe cases, the disease can involve other organs, including the kidneys, liver, and lungs. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may have more severe organ involvement. Over time, the persistent dryness can lead to complications such as dental decay, oral infections, and vision problems. The disease can also cause fatigue and joint pain.

  • Rheumatoid Arthritis

    Rheumatoid Arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body's own tissues, leading to inflammation. This inflammation can cause joint pain, swelling, and stiffness, often affecting the hands and feet. As the disease progresses, it can lead to joint damage and deformities. The inflammation can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. The severity and progression of symptoms can vary widely among individuals.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514596-18-00Protocol codeCYTB323M12101BEstimated enrolment28 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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