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New drug aims to control rare blood disorders without lifelong steroids

NCT ID NCT07104565

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 10 times

Summary

This study tests a drug called tafasitamab in adults with two rare autoimmune blood disorders: immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA). The goal is to see if it can safely raise blood cell counts and reduce the need for other treatments. About 56 participants will receive the drug and be monitored for up to 48 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Ability to comprehend and willingness to sign a written ICF for the study. * Aged ≥ 18 years. * Confirmed historical diagnosis of one of the following autoimmune blood disorders: * Primary ITP. * Primary wAIHA. * No history of splenectomy. * Confirmed transient response to at least 1 prior early-line treatment (eg, corticosteroids, IVIG, rituximab): * Primary ITP: Increase in platelet count to ≥ 30 × 109/L with at least a 2-fold increase of baseline platelet count. * Primary wAIHA: Increase in hemoglobin to ≥ 10 g/dL with an increase of at least 2 g/dL from baseline. * Received ≥ 1 standard course of rituximab (375 mg/kg × 4 weekly doses or 2 doses of 1000 mg flat dose every 2 weeks) with last dose given at least 6 months prior to initiation of study treatment. Note: If rituximab was the only prior therapy, individuals with NR to rituximab will not be eligible. * Primary ITP: a PR (platelet count ≥ 30 × 109/L with at least a 2-fold increase of baseline platelet count) within 6 months of the last administered dose followed by relapse OR a CR (platelet count \> 100 × 109/L) lasting \< 48 weeks OR NR (platelet count \< 30 × 109/L or less than 2-fold increase of baseline platelet count or bleeding) within 6 months of the last administered dose. * Primary wAIHA: a PR with hemoglobin ≥ 10 g/dL and with an increase of at least 2 g/dL from baseline OR a CR (hemoglobin ≥ 12 g/dL and normalization of hemolytic markers) OR NR (hemoglobin \< 10 g/dL or \< 2 g/dL increase of baseline hemoglobin). * Persistent or chronic active primary ITP or active primary wAIHA with indication for treatment at the time of inclusion. * Primary ITP: platelet count \< 30 × 109/L within the 15 days before treatment is scheduled to begin (Day 1). Note: Participants treated with a rescue therapy during screening in response to a documented platelet count \< 30 × 109/L are eligible, irrespective of platelet count within 15 days of Day 1. • Primary wAIHA: hemoglobin \< 10 g/dL documented with DAT result positive for IgG, with or without C3d, and evidence of hemolysis based on low haptoglobin, elevated LDH, and/or indirect bilirubin. * ECOG performance status of 0 to 2. * Willingness to avoid pregnancy or fathering children. * Further inclusion criteria apply. Exclusion Criteria: * Clinical manifestations typical for cold agglutinin disease. * Life-threatening bleeding or urgent need to elevate the platelet count for primary ITP or hemodynamic instability or hemoglobin \< 6 g/dL with urgent need to elevate hemoglobin for primary wAIHA within 2 weeks prior to Day 1. * Prior treatment with anti-CD19 therapy (eg, mAb, bispecific T-cell engager, or CAR T cell) for any indication. * Previous severe allergic reaction to a mAb or known allergy to any component/excipient of tafasitamab. * Changes in doses (\> 10%) of permitted disease-related therapies, including oral corticosteroids and TPO-RA (primary ITP participants) within 2 weeks prior to Day 1, or change in ESA (primary wAIHA participants) dose within 2 weeks prior to Day 1. * Evidence of hypogammaglobulinemia during screening (IgA \< 70 mg/dL, IgG \< 700 mg/dL, and/or IgM \< 40 mg/dL) and frequent and/or severe infections. * Women who are pregnant or breastfeeding. * History of malignancy except for the following: * Malignancy treated with curative intent with no evidence of active disease for more than 2 years before screening. * Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanoma skin cancer. * Adequately treated carcinoma in situ without current evidence of disease. * Congestive heart failure (left ventricular ejection fraction of \< 50%, assessed by 2 dimensional echocardiography or a multigated acquisition scan). * Participants with: * Known positive test result for HCV (with HCV antibody serology testing) and a positive test for HCV RNA. Note: Participants with positive serology must have been tested for HCV RNA and are eligible only in the case of negative HCV RNA test result. • Known positive test result for chronic HBV infection (defined by HBsAg positivity or positive HBV DNA test result). Note: Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable, provided that they are willing to undergo monthly ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines. Note: Participants who have protective titers of HBsAb (HBsAb positive, HBcAb negative, and HBsAg negative) after vaccination or prior HBV infection are eligible. • Seropositivity for or history of active viral infection with HIV. * Active systemic infection (including infection with SARS-CoV-2). * Participants in a severely immunocompromised state, per investigator's clinical assessment. * Receipt of a live-attenuated vaccine within 4 weeks prior to the first infusion of tafasitamab (inactivated and killed vaccines are acceptable). * Coagulation or platelet function abnormality. * An active medical condition with a strong indication for treatment with anticoagulation agents (eg, intracoronary stent within 12 months). * Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * Toxicities related to prior therapies must be CTCAE (v5.0) ≤ Grade 1 at the time of study treatment/enrollment (except for chronic toxicities \[≤ Grade 2\] not expected to resolve). * Chronic infectious disease requiring systemic antibiotics or antifungal or antiviral medications. * Unwillingness to undergo transfusion with blood components. * Current use of prohibited medication as described in the protocol. * Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy. * Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia, warm type autoimmune thrombocytopenic purpura Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune thrombocytopenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    39 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Amsterdam Umc, Locatie Vumc

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Azienda Ospedale Universita Di Padova

    RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Federico Ii

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliero-Universitaria Orsola-Malpighi - Universita Degli Studi Di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Montichiari)

    RECRUITING

    Brescia, 25123, Italy

  • Barts Hospital

    RECRUITING

    London, E1 2ES, United Kingdom

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 03128, Australia

  • Castle Hill Hospital

    RECRUITING

    Cottingham, HU16 5JQ, United Kingdom

  • Chru de Nancy- Hopital de Brabois

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • Chu Angers - Hôpital Hôtel Dieu

    RECRUITING

    Angers, 49933, France

  • Chu Bordeaux - Hôpital Haut-Lévêque

    RECRUITING

    Pessac, 33604, France

  • Chu Caen - Hôpital de La Côte de Nacre

    RECRUITING

    Caen, 14033, France

  • Chu Dijon - Hopital Du Bocage

    RECRUITING

    Dijon, 21079, France

  • Erasmus Medisch Centrum

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    RECRUITING

    Roma, 00136, Italy

  • Fred Hutchinson Cancer Center

    NOT_YET_RECRUITING

    Seattle, Washington, 98109, United States

  • Gnp Research

    RECRUITING

    Cooper City, Florida, 33024, United States

  • Hopital Purpan

    RECRUITING

    Toulouse, 31059, France

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hôpital Henri Mondor

    RECRUITING

    Créteil, 94010, France

  • Ico Badalona. Hospital Universitario Germans Trias I Pujol

    RECRUITING

    Badalona, 08916, Spain

  • Inova Schar Cancer Institute

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

    RECRUITING

    Meldola, 47014, Italy

  • Monash Medical Centre Clayton

    RECRUITING

    Clayton, Victoria, 03168, Australia

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale

    RECRUITING

    Glendale, Arizona, 85304, United States

  • Plymouth Hospitals Nhs Trust

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Princess Alexandra Hospital Australia

    RECRUITING

    Woolloongabba, Queensland, 04102, Australia

  • Radboudumc

    RECRUITING

    Nijmegen, 6500 HB, Netherlands

  • Rocky Mountain Cancer Centers

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • St Vincent'S Hospital Sydney

    RECRUITING

    Darlinghurst, New South Wales, 02010, Australia

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 03004, Australia

  • Townsville University Hospital

    RECRUITING

    Douglas, Queensland, 04814, Australia

  • University Medical Center Utrecht

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • Usc Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06510, United States

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