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Not yet recruitingRare disease

Study comparing rapcabtagene autoleucel and rituximab in patients with severe refractory diffuse cutaneous systemic sclerosis

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with diffuse cutaneous systemic sclerosis (dcSSc), a severe autoimmune disease that causes hardening of the skin and can affect internal organs. The main treatment being tested is rapcabtagene autoleucel (also known as YTB323), which is a type of cell therapy where a patient's own immune cells are modified to fight the disease. This treatment will be compared to rituximab, which is an existing medication used to treat autoimmune conditions.

The purpose of this research is to determine if rapcabtagene autoleucel is more effective than rituximab in treating severe dcSSc that has not responded well to previous treatments. Before receiving the main treatment, patients may receive preparation medications including cyclophosphamide, fludarabine phosphate, and tocilizumab. All medications will be given through an intravenous line directly into the bloodstream.

Throughout the study, which lasts for 52 weeks, doctors will monitor changes in lung function, skin thickness, and ability to perform daily activities. They will also track any side effects that may occur during or after treatment. The study will continue to follow participants for several years to understand the long-term effects of the treatment.

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 Treatment Phase

    You will receive lymphodepletion therapy consisting of fludarabine phosphate and cyclophosphamide through intravenous infusion

    This preparatory treatment helps your body receive the main therapy

  2. Step 2

    Main Treatment Administration

    You will receive a single infusion of rapcabtagene autoleucel (YTB323) through intravenous administration

    This is a specialized treatment that uses modified immune cells to target your condition

  3. Step 3

    Monitoring Period

    Regular assessments will track your progress over 52 weeks

    Medical staff will measure changes in your lung function, skin condition, and overall health status

    Your ability to perform daily activities will be evaluated throughout this period

  4. Step 4

    Safety Evaluations

    Regular health checks will include blood tests, vital signs monitoring, and heart activity recordings (ECG)

    If needed, you may receive tocilizumab through intravenous infusion to manage specific side effects

    Any health changes or side effects will be documented and addressed

  5. Step 5

    Final Assessment

    At week 52, a comprehensive evaluation will determine the effectiveness of the treatment

    This includes measuring improvements in your condition using specialized assessment tools

    Long-term follow-up will continue to monitor your health status

Who can join the trial?

11 criteria

  • You must be diagnosed with diffuse cutaneous systemic sclerosis (dcSSc) according to specific medical criteria established by rheumatology experts
  • Your disease symptoms (not including Raynaud's phenomenon - a condition where fingers and toes feel numb and cold) must have started within the last 7 years. These symptoms may include:
    • Swollen hands
    • Hardening of the skin
    • Sores on fingers or toes
    • Joint pain
    • Difficulty breathing
    • You must have severe, progressive disease with at least one of these conditions:
      • Progressive lung involvement (breathing problems related to systemic sclerosis)
      • Severe, worsening skin involvement (skin hardening that is getting worse)
      • Heart problems related to systemic sclerosis
      • Both men and women can participate in this study
      • Adults of all ages can participate

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Previous treatment with rituximab (a type of medication that affects immune system cells)
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • History of severe allergic reactions to biological treatments
  • Current pregnancy or breastfeeding
  • Significant heart problems or uncontrolled high blood pressure
  • Severe kidney or liver problems
  • Active cancer or history of cancer in the past 5 years (except for successfully treated skin cancer)
  • Major surgery within 8 weeks before starting the study
  • Participation in other clinical trials within 30 days before this study
  • Mental conditions that could interfere with following study procedures
  • Substance abuse within the past year
  • Any condition that, in the opinion of study doctors, would make participation unsafe
  • Unable to provide informed consent
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Investigated drugs

  • Rapcabtagene autoleucel

    is a type of cell therapy where a patient's own T cells (a type of immune cell) are modified in a laboratory. These modified cells are designed to target specific cells in the body that are involved in systemic sclerosis, a serious autoimmune condition affecting the skin and internal organs. The therapy is given as a single infusion into the bloodstream.

  • Rituximab

    is an antibody medication that works by targeting and reducing certain types of B cells (immune cells) in the body. It is commonly used to treat various autoimmune conditions and certain types of cancer. The medication is given through an infusion into the bloodstream and works by modifying the immune system's response.

What is already known about the treatment

  • Rapcabtagene autoleucel

    A cell therapy product administered as a single intravenous infusion, consisting of genetically modified T cells designed to target specific cells involved in systemic sclerosis. This innovative treatment belongs to the class of CAR T-cell therapies and is currently being investigated in clinical trials for the treatment of diffuse cutaneous systemic sclerosis (dcSSc). The therapy works by reprogramming the patient's own immune cells to recognize and combat the cells responsible for the excessive collagen production and tissue fibrosis characteristic of systemic sclerosis.

  • Rituximab

    An established monoclonal antibody medication administered through intravenous infusion, which targets and depletes B cells in the immune system. It belongs to the class of biological response modifiers and is currently used in various autoimmune conditions, with ongoing investigation for diffuse cutaneous systemic sclerosis. The medication works by binding to CD20 proteins on B cells, leading to their destruction and thereby reducing inflammatory and autoimmune responses in the body.

Investigated diseases

Diffuse cutaneous systemic sclerosis (dcSSc) - A rare autoimmune disease that causes hardening and tightening of the skin and connective tissues throughout the body. The condition begins with inflammation and swelling of the skin, which later leads to excessive collagen production causing skin thickening. It affects large areas of the skin, particularly on the trunk, face, and limbs. The disease typically progresses relatively quickly over the first few years after onset. Internal organs may also be affected as the condition develops. The term "diffuse" refers to the widespread nature of skin involvement, distinguishing it from other forms of systemic sclerosis.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510380-34-00Protocol codeCYTB323K12201Estimated enrolment143 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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