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Study of Isatuximab for Patients with Type I Cryoglobulinemia

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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 a condition called Type I Cryoglobulinemia. This is a rare blood disorder where abnormal proteins in the blood can cause various symptoms, including issues with the skin, joints, kidneys, and other organs. The study is testing a treatment using a medication called Isatuximab, which is given as a solution through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well Isatuximab works in treating the symptoms of Type I Cryoglobulinemia. Participants in the study will receive the medication over a period of time, and their health will be monitored to see if there is a complete clinical response, meaning that the symptoms of the disease improve significantly. The study will also look at the safety of the treatment and any side effects that may occur.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. The study will track various health indicators, such as the presence of disease symptoms, kidney function, and overall quality of life. The study aims to provide valuable information on the effectiveness and safety of Isatuximab for people with Type I Cryoglobulinemia.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring all criteria are met.

    A blood test is performed to check for specific markers and ensure no infections are present.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of isatuximab through an intravenous infusion. This means the medication is given directly into a vein.

    The dosage and frequency of the medication are determined by the study protocol and are explained before starting the treatment.

  3. Step 3

    Regular monitoring

    Regular monitoring is conducted to assess the response to the treatment. This includes scheduled visits at specific weeks, such as week 4, week 12, and week 20.

    During these visits, various tests are performed to evaluate the effectiveness of the treatment and monitor any side effects.

  4. Step 4

    Evaluation of response

    At week 20, a comprehensive evaluation is conducted to determine the complete clinical response rate. This involves assessing the improvement in symptoms related to cryoglobulinemia vasculitis.

    Additional assessments may include checking for the clearance of cryoglobulinemia and other related factors.

  5. Step 5

    Follow-up period

    After the initial 20-week period, a follow-up phase continues for up to 48 weeks to monitor long-term effects and any potential relapses.

    During this time, regular check-ups are scheduled to ensure ongoing health and safety.

Who can join the trial?

9 criteria

  • Must be over 18 years old.
  • Must provide written informed consent, which means you agree to participate after being fully informed about the study.
  • Must have a condition called Monoclonal gammopathy of unknown significance (MGUS) with a specific type of protein called monoclonal IgG.
  • Must have active cryoglobulinemia vasculitis, which is a condition where abnormal proteins in the blood cause inflammation in various parts of the body like skin, joints, kidneys, lungs, heart, muscles, digestive system, and nervous system.
  • Must be either new to treatment or have had a return of type I cryoglobulinemia after previous treatment.
  • Must be affiliated with the National French social security system.
  • Must agree to use effective contraception during the study and for at least 5 months after the last dose of the study treatment:
    • Male participants: Must use a highly effective method of contraception and refrain from donating sperm during this period.
    • Female participants: Must not be pregnant or breastfeeding and must either not be of childbearing potential or have a negative pregnancy test before starting the study. They must also use a highly effective method of contraception and refrain from donating eggs during this period.
    • Must have negative test results for HIV, Hepatitis B (HBs Ag test), and Hepatitis C (HCV) or a negative HCV RNA test if HCV serology was positive within 3 months before joining the study.

Who cannot join the trial?

12 criteria

  • Patients with any other serious medical condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another type of cancer in the past 5 years, except for skin cancer that is not melanoma.
  • Patients who have an active infection that requires treatment.
  • Patients who have received another investigational drug within the last 30 days.
  • Patients with known allergies to the study medication or its ingredients.
  • Patients with severe heart disease.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver disease.
  • Patients with severe kidney disease.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

Isatuximab is a medication being studied for its potential to help people with a condition called type I cryoglobulinemia. This condition involves abnormal proteins in the blood that can cause various health issues. Isatuximab is a type of therapy known as a monoclonal antibody. It works by targeting specific cells in the immune system that may be involved in the disease process. The goal of using Isatuximab in this study is to see if it can help reduce or eliminate the symptoms of type I cryoglobulinemia, leading to a complete clinical response, which means the symptoms of the disease are significantly reduced or gone.

What is already known about the treatment

Isatuximab – Isatuximab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in medical research, particularly in a pilot study for its effects on type I cryoglobulinemia, a rare blood disorder. The main therapeutic indication for Isatuximab in this study is to evaluate its ability to achieve a complete clinical response in patients with type I IgG cryoglobulinemia. At the molecular level, Isatuximab works by targeting and binding to a specific protein on the surface of certain immune cells, which helps to modulate the immune system's activity. It is classified pharmacologically as a monoclonal antibody, a type of medication designed to interact with specific proteins in the body.

Investigated diseases

Type I Cryoglobulinemia – Type I cryoglobulinemia is a condition characterized by the presence of abnormal proteins in the blood that precipitate at low temperatures. These proteins, known as cryoglobulins, can lead to blood vessel inflammation, a condition called vasculitis. The disease often affects the skin, kidneys, and nerves, causing symptoms such as skin rashes, joint pain, and kidney problems. As the disease progresses, it can lead to more severe symptoms, including significant kidney damage and nerve issues. The condition is often associated with other disorders, such as certain blood cancers. The progression of the disease can vary, with some individuals experiencing mild symptoms and others facing more severe complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515039-31-00Protocol codeAPHP210369Estimated enrolment21 patientsSponsorAssistance Publique Hopitaux De Paris

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).