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A study to evaluate the safety and effectiveness of tafasitamab in adults with autoimmune thrombocytopenia or autoimmune hemolytic anemia

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 study aims to evaluate the safety and effectiveness of tafasitamab in adults living with certain rare conditions where the body's immune system attacks its own blood cells. These conditions include Immune-mediated thrombocytopenia, which is a disorder that leads to a low number of platelets, the cells responsible for blood clotting, and Autoimmune hemolytic anemia, a condition where the immune system destroys red blood cells. In these diseases, the body mistakenly identifies its own blood components as harmful substances and begins to attack them.

The treatment being studied is tafasitamab, which is administered through intravenous infusion. This means the medication is delivered directly into a vein over a set period of time. Participants in the study will receive this medication to see how well it helps stabilize blood cell levels and how the body reacts to the drug.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment administration

    The tafasitamab (minjuvi) treatment is provided as an intravenous infusion, which means the medicine is delivered directly into a vein.

    The dosage for each administration is 1000 mg.

  2. Step 2

    Monitoring and evaluations

    Regular monitoring is performed to assess safety and how the body tolerates the medicine. this includes checking vital signs (such as blood pressure and heart rate), performing electrocardiograms (ECGs, which are tests that record the electrical activity of the heart), and conducting clinical laboratory blood sample evaluations.

    Blood tests are also used to track platelet counts (the cells that help blood clot) and hemoglobin levels (a protein in red blood cells that carries oxygen).

    Blood markers related to hemolysis (the destruction of red blood cells), such as unconjugated bilirubin, LDH, haptoglobin, and reticulocytes, are monitored to check for improvements.

    The physical ability to perform daily activities, known as performance status, is also evaluated.

  3. Step 3

    Assessment of response

    The effectiveness of the treatment is measured at specific intervals, including week 24 and week 48.

    A complete remission (CR) is sought, which refers to a state where blood counts, such as platelets or hemoglobin, return to a healthy, stable level without the need for rescue therapy (additional urgent treatment).

    A partial response (PR) is also monitored, which indicates an improvement in blood counts compared to the starting levels, even if they have not yet reached the full healthy range.

    Between day 56 and week 48, the stability of the blood cell response is observed to determine how long the effects of the medicine last.

Who can join the trial?

15 criteria

  • You must be at least 18 years old and weigh at least 50 kg (about 110 pounds).
  • You must have signed a document called informed consent, which means you have been told about the study and agree to join.
  • You must have a confirmed diagnosis of either primary ITP (a condition where your body has a low number of platelets, which are blood cells that help with clotting) or primary wAIHA (a condition where your body destroys its own red blood cells, which carry oxygen through the body).
  • For primary ITP, your low platelet count must have lasted between 3 and 12 months, or longer than 12 months.
  • For primary wAIHA, you must have anemia (low red blood cell count) and test positive on a DAT (a test that checks if your immune system is attacking your red blood cells).
  • You must not have had a splenectomy, which is the surgical removal of the spleen.
  • You must have had a temporary positive response to at least one previous treatment, such as corticosteroids (steroid medicines), IVIG (special proteins given through a vein), or rituximab (a specific medicine used to treat immune issues).
  • If you have primary ITP, your previous treatment must have increased your platelet count to at least 30 x 10⁹/L.
  • If you have primary wAIHA, your previous treatment must have increased your hemoglobin (the protein in red blood cells that carries oxygen) to at least 10 g/dL.
  • You must have received at least one standard course of rituximab, and your last dose must have been at least 6 months before starting this study.
  • You must have active disease at the time you join the study. This means for primary ITP, your platelet count is below 30 x 10⁹/L, or for primary wAIHA, your hemoglobin is below 10 g/dL and shows signs of hemolysis (the breaking down of red blood cells).
  • You must have an ECOG performance status of 0 to 2, which is a scale used to measure how well you can perform daily activities and your overall physical health.
  • You must agree to use effective contraception (methods to prevent pregnancy) or avoid fathering children during the study and for 90 days after the last dose.
  • Male participants who can have children must agree to avoid donating sperm for 90 days after the last dose.
  • Female participants who can become pregnant must have a negative pregnancy test and agree to use birth control and avoid donating eggs for 90 days after the last dose.

Who cannot join the trial?

17 criteria

  • Symptoms of cold agglutinin disease, which is a condition where the body's immune system attacks red blood cells in response to cold temperatures, including skin discoloration like acrocyanosis (blueish skin on fingers or toes).
  • Congestive heart failure, a condition where the heart cannot pump blood effectively, specifically if the left ventricular ejection fraction (a measurement of how much blood the heart pumps out with each beat) is less than 50%.
  • Active infections, including HCV (Hepatitis C virus), HBV (Hepatitis B virus), or HIV (Human Immunodeficiency Virus).
  • Any active systemic infection, which means an infection spreading throughout the entire body, such as COVID-19.
  • Having a severely immunocompromised system, which means your body's ability to fight off infections is greatly reduced.
  • Receiving a live-attenuated vaccine (a type of vaccine that uses a weakened form of a germ) within 4 weeks before the first dose of the study medication.
  • Disorders that affect coagulation (the body's ability to form blood clots) or platelet function (how well the cells that help stop bleeding work), or the need for anticoagulation (blood-thinning medication).
  • Any health condition that makes it difficult to participate in the study or makes the study results hard to understand.
  • Ongoing toxicities (harmful side effects) from previous medical treatments that are higher than a mild or moderate level.
  • Life-threatening bleeding or a sudden, urgent need to increase platelet counts (the number of cells that help blood clot) or hemoglobin levels (the protein in red blood cells that carries oxygen) within 2 weeks before the study starts.
  • Previous treatment with anti-CD19 therapy, which refers to specific types of drugs or cell therapies designed to target certain immune cells.
  • A history of severe allergic reactions to monoclonal antibodies (a type of laboratory-made protein used as medicine) or known allergies to any ingredients in the study drug.
  • Taking immunosuppressant drugs (medicines that lower the body's immune response) other than steroids within 2 weeks of the study, or taking other experimental drugs within 4 weeks.
  • Recent changes in the dose of allowed medications used to treat your condition, such as corticosteroids (steroid medicines used to reduce inflammation) or other specific disease treatments, within 2 weeks.
  • Evidence of hypogammaglobulinemia, which is a condition where there are too few immunoglobulins (antibodies that help fight infection) in the blood, especially if accompanied by frequent or severe infections.
  • Being pregnant or breastfeeding.
  • A history of malignancy (cancer), unless it was treated with the goal of a full cure and there has been no sign of active disease for more than 2 years, or certain types of skin cancers that are currently well-controlled.
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Investigated drugs

Tafasitamab is a medication given through a vein to help treat certain autoimmune blood disorders where the immune system incorrectly attacks the body's own blood cells.

What is already known about the treatment

Tafasitamab - This medication is administered through an intravenous infusion, which means it is delivered directly into a vein as a liquid solution. Currently being studied for its potential in treating autoimmune blood cell disorders, it is classified as a monoclonal antibody. It works at the molecular level by attaching itself to a specific protein on the surface of certain immune cells to help regulate the body's immune response. This treatment is primarily being investigated for patients suffering from conditions where the immune system mistakenly attacks and destroys their own blood cells.

Investigated diseases

  • Immune thrombocytopenia

    This is a condition where the body's immune system mistakenly attacks and destroys its own platelets. Platelets are the small cells in the blood that help it clot. As the disease progresses, the number of platelets in the bloodstream decreases. This reduction can lead to an increased tendency for bleeding. The severity of the condition often depends on how low the platelet count falls.

  • Autoimmune hemolytic anemia

    This condition occurs when the immune system produces antibodies that target and destroy red blood cells. These red blood cells are responsible for carrying oxygen throughout the body. As the process continues, the body cannot replace the destroyed cells quickly enough. This leads to a decrease in the total number of healthy red blood cells in circulation. The disease can progress by causing a steady decline in the ability of the blood to transport oxygen efficiently.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-521286-27-00Protocol codeINCA000585-201Estimated enrolment56 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

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