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A Study of Cizutamig for Patients with Severe Autoimmune Inflammatory Diseases That Did Not Respond to Previous Treatments

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study involves patients with severe immune-mediated inflammatory diseases that have not responded well to previous treatments. The specific conditions being studied are primary Sjögren's disease, idiopathic inflammatory myopathy, systemic sclerosis, and rheumatoid arthritis. The treatment being investigated is cizutamig, which is a bispecific antibody that works by engaging certain immune cells in the body. This medication is given as an intravenous infusion, meaning it is delivered directly into a vein.

The purpose of this study is to assess the safety of cizutamig in patients with these severe inflammatory conditions and to examine how well the treatment works in controlling disease activity. During the study, patients will receive the medication and will be closely monitored for any side effects, particularly Cytokine Release Syndrome and other treatment-related reactions. The study will track various measures of disease activity specific to each condition, such as skin thickness scores for systemic sclerosis, muscle strength measurements for inflammatory myopathy, disease activity scores for rheumatoid arthritis, and symptom scores for Sjögren's disease. For patients who have lung involvement, lung function tests will also be performed.

The study will last approximately 52 weeks, with regular assessments at different time points to evaluate both the safety and effectiveness of the treatment. Patients will have measurements taken at weeks 16, 24, and 52 to see how their disease responds to cizutamig. The study will also look at whether patients can reduce or stop other medications they may be taking, how often their disease flares up, and how their overall quality of life and daily functioning change during the treatment period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    Upon joining the trial, your treatment will begin with cizutamig, which is the medication being tested in this study.

    The medication will be given through intravenous infusion, which means it will be delivered directly into your vein through a needle.

    The medication is provided as a solution for infusion.

  2. Step 2

    Treatment administration phase

    Your treatment will continue for a specific period during the trial.

    The exact dosage, frequency, and duration of the medication administration will be determined based on the trial protocol.

    Your healthcare team will monitor your response to the treatment throughout this phase.

  3. Step 3

    Week 16 assessment

    At week 16, your condition will be evaluated to measure how your body has responded to the treatment.

    Depending on your specific condition, different measurements will be taken to assess improvement or changes in your symptoms.

    This assessment is an important milestone in the trial to evaluate the effectiveness of the medication.

  4. Step 4

    Week 24 assessment

    At week 24, another evaluation will be conducted to continue monitoring your response to the treatment.

    Additional measurements will be taken to track any changes in your condition compared to earlier assessments.

  5. Step 5

    Treatment completion and final assessment

    The treatment phase will continue until week 52, which marks one year from the start of your participation.

    At week 52, a comprehensive final evaluation will be performed to assess the overall effectiveness of the medication.

    Various aspects of your health and disease activity will be measured and compared to your condition at the beginning of the trial.

  6. Step 6

    Post-treatment monitoring

    After your last dose of cizutamig, your health will continue to be monitored for 28 days.

    This monitoring period is important to observe any delayed effects or side effects that may occur after treatment has ended.

    Your healthcare team will track any adverse events or changes in your condition during this time.

  7. Step 7

    Safety monitoring throughout the trial

    Throughout your participation, your healthcare team will closely monitor for specific side effects, including Cytokine Release Syndrome (a reaction that can occur when certain cells in your immune system release substances into your blood) and Immune Cell Associated Neurotoxicity Syndrome (effects on the nervous system related to the treatment).

    Any adverse events or serious adverse events will be recorded and assessed during the entire trial period.

    Regular safety checks will be performed at each visit to ensure your wellbeing.

Who can join the trial?

24 criteria

  • You must provide written informed consent and agree to data protection rules before any study procedures begin
  • You must be at least 18 years old at the time of consent
  • You must be willing and able to follow all study procedures and requirements
  • You must have updated vaccinations according to recommendations for people with weakened immune systems
  • If you are a male participant who has not had surgery to prevent fathering children, you must agree to use two acceptable methods of contraception (birth control methods such as spermicide and condom) during the study and must not father a child from the time you sign the consent form throughout the study
  • If you are a female who can become pregnant, you must have a negative pregnancy test at screening (the initial evaluation visit) and must agree to use a highly effective birth control method from the time you sign the consent form throughout the study. If you take birth control pills, you must also agree to use two other acceptable methods of contraception during the study
  • For Rheumatoid Arthritis patients: You must meet the 2010 classification criteria for rheumatoid arthritis (a condition where the immune system attacks the joints causing pain and swelling)
  • For Rheumatoid Arthritis patients: You must test positive for rheumatoid factor or anti-citrullinated protein antibody (specific proteins in your blood that indicate rheumatoid arthritis) at screening
  • For Rheumatoid Arthritis patients: Your disease activity score must be greater than 3.2 at screening, which measures how active your disease is
  • For Rheumatoid Arthritis patients: You must have at least 3 tender joints and at least 3 swollen joints at screening
  • For Rheumatoid Arthritis patients: You must have failed treatment with at least one conventional disease-modifying drug and at least two other disease-modifying drugs with different ways of working, where failure means the treatment did not work well enough after at least 3 months or you could not tolerate it
  • For Systemic Sclerosis patients: You must meet the 2013 classification criteria for systemic sclerosis (a condition where the immune system causes hardening and tightening of the skin and connective tissues)
  • For Systemic Sclerosis patients: You must test positive for at least one specific antibody associated with systemic sclerosis
  • For Systemic Sclerosis patients: You must have diffuse skin disease, meaning widespread skin involvement
  • For Systemic Sclerosis patients: You must have severe disease defined by skin disease that has worsened, lung disease that has worsened, or heart involvement with elevated troponin levels
  • For Systemic Sclerosis patients: You must have failed treatment with at least two medications with different ways of working, where failure means the treatment did not work well enough after at least 3 months or you could not tolerate it
  • For Inflammatory Myopathy patients: You must have a diagnosis of inflammatory myopathy (conditions where the immune system attacks the muscles causing weakness) according to 2017 classification criteria
  • For Inflammatory Myopathy patients: You must test positive for at least one specific antibody associated with myositis (muscle inflammation)
  • For Inflammatory Myopathy patients: You must have severe, active disease shown by recent evidence of muscle inflammation or lung disease that has worsened
  • For Inflammatory Myopathy patients: You must have failed treatment with at least two medications with different ways of working, where failure means the treatment did not work well enough after at least 3 months or you could not tolerate it
  • For Sjögren's Disease patients: You must meet the 2016 classification criteria for Sjögren's disease (a condition where the immune system attacks glands that produce moisture, causing dry eyes and mouth)
  • For Sjögren's Disease patients: You must test positive for SSA antibodies (specific proteins in your blood) in your blood
  • For Sjögren's Disease patients: You must have moderate to severe disease with a disease activity score of at least 5
  • For Sjögren's Disease patients: You must have failed treatment with at least two medications with different ways of working, where failure means the treatment did not work well enough after at least 3 months or you could not tolerate it

Who cannot join the trial?

15 criteria

  • You have an active infection or have had a serious infection in the past 3 months that required treatment with antibiotics given through a vein
  • You have a history of tuberculosis (a bacterial lung infection) or have an active tuberculosis infection
  • You have a known infection with HIV (a virus that affects the immune system), hepatitis B or hepatitis C (viruses that affect the liver)
  • You have received a live vaccine within 4 weeks before starting the study treatment
  • You have a history of cancer within the past 5 years, except for certain skin cancers or early-stage cervical cancer that have been successfully treated
  • You have a known allergy or severe reaction to the study medicine or any of its ingredients
  • You are pregnant, breastfeeding, or planning to become pregnant during the study
  • You have severe heart disease, including recent heart attack or unstable chest pain
  • You have severe lung disease that requires oxygen therapy
  • You have severe kidney disease requiring dialysis (a treatment to filter waste from blood when kidneys do not work properly)
  • You have severe liver disease
  • You have an active bleeding disorder or are at high risk for serious bleeding
  • You have received certain treatments that affect your immune system within specific time periods before joining the study
  • You have another autoimmune disease (condition where the body attacks itself) that is not part of this study
  • You have a condition that affects your brain or nervous system that could interfere with the study
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Investigated drugs

Cizutamig is an experimental medication being tested in this study. It is a type of antibody that works by helping the body's immune system cells called T-cells to recognize and target specific proteins. This medication is designed to help treat certain immune system disorders where the body's immune system is overactive and causes inflammation and damage to the body's own tissues.

What is already known about the treatment

Cizutamig – Cizutamig is an experimental bispecific antibody medication that is currently being studied in clinical trials for severe autoimmune diseases that have not responded to standard treatments, including primary Sjögren's disease, inflammatory myopathy, systemic sclerosis, and rheumatoid arthritis. It is administered as an infusion into the bloodstream and works by simultaneously binding to two different targets: BCMA (a protein found on certain immune cells called B cells and plasma cells) and CD3 (a protein found on T cells), which brings these immune cells together so that T cells can eliminate the harmful B cells and plasma cells that contribute to autoimmune inflammation. This medication belongs to a class of drugs called bispecific T-cell engaging antibodies, which represent a newer approach to treating immune-mediated diseases by redirecting the body's own immune system. The safety and effectiveness of cizutamig are still being evaluated in early-phase research studies, and it is not yet approved for routine medical use.

Investigated diseases

  • Primary Sjögren's Disease

    Primary Sjögren's disease is an autoimmune condition where the body's immune system mistakenly attacks its own moisture-producing glands. The disease mainly affects the tear and saliva glands, leading to dry eyes and dry mouth. Over time, the condition can progress to affect other organs and systems in the body. Patients may experience fatigue, joint pain, and swelling of the salivary glands. The disease can also cause complications in the lungs, kidneys, blood vessels, and nervous system. The severity of symptoms varies among individuals, with some experiencing mild discomfort while others face more significant health challenges.

  • Idiopathic Inflammatory Myopathy

    Idiopathic inflammatory myopathy is a group of rare autoimmune disorders characterized by chronic muscle inflammation and weakness. The immune system attacks the muscle fibers, causing them to become inflamed and damaged. Muscle weakness typically develops gradually and affects the muscles closest to the trunk of the body, such as those in the hips, thighs, shoulders, and neck. Patients may have difficulty climbing stairs, lifting objects, or raising their arms above their head. Some forms of this disease can also affect the skin, lungs, and heart. The condition can progress at different rates, with periods of worsening symptoms alternating with periods of stability.

  • Systemic Sclerosis

    Systemic sclerosis is an autoimmune disease that causes abnormal growth of connective tissue in the skin and internal organs. The disease leads to hardening and tightening of the skin, particularly on the hands, arms, and face. As the condition progresses, it can affect blood vessels and internal organs including the lungs, heart, kidneys, and digestive system. Patients often experience Raynaud's phenomenon, where fingers and toes change color in response to cold or stress. The skin becomes thick and tight, which can limit movement and cause discomfort. The progression of the disease varies widely, with some people experiencing rapid changes while others have a slower course.

  • Rheumatoid Arthritis

    Rheumatoid arthritis is a chronic autoimmune disease that primarily affects the joints throughout the body. The immune system attacks the lining of the joints, causing inflammation, pain, swelling, and stiffness. The disease typically affects joints on both sides of the body symmetrically, most commonly the hands, wrists, and knees. Over time, the inflammation can damage cartilage and bone, leading to joint deformity and loss of function. The condition can also affect other parts of the body, including the eyes, lungs, heart, and blood vessels. Symptoms often fluctuate, with periods of increased disease activity called flares alternating with periods of relative remission.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-522857-20-00Protocol codeTMP-23062025-2Estimated enrolment12 patientsSponsorFraunhofer Institute For Translational Medicine And Pharmacology ITMP

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