Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

NCT07104565 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: INCA000585-201
• Study Type: interventional
• Target: 56
• Locations: 7 countries
• Sites: 40

Brief Summary

This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.

Conditions

Immune Thrombocytopenia

Keywords

primary warm autoimmune hemolytic anemia; primary immune thrombocytopenia; anti-CD19 monoclonal antibody

Outcome Measures

Primary Outcomes (3)

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Defined as any adverse event, either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug.

  Up to 52 weeks

• Stable platelet response

  Defined as platelet count ≥ 50 × 109/L in the absence of clinically significant bleeding or rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary ITP.

  After Day 56 up to Week 48

• Stable hemoglobin response

  Defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline in the absence of rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary wAIHA.

  After Day 56 up to Week 48

Secondary Outcomes (14)

• Complete Response (CR)

  Week 24

• CR (complete remission)

  Week 48

• Partial Response (PR)

  Week 24

• Duration of stable platelet response

  Up to Week 48

• Duration of CR

  Up to Week 48

Study Arms (2)

Cohort 1 - primary immune thrombocytopenia (ITP)

EXPERIMENTAL

INCA000585 will be administered intravenously.

Drug: INCA000585

Cohort 2 - primary warm autoimmune hemolytic anemia (wAIHA)

EXPERIMENTAL

INCA000585 will be administered intravenously.

Drug: INCA000585

Interventions

INCA000585 DRUG

Tafasitamab will be administered intravenously at protocol defined timepoints.

Cohort 1 - primary immune thrombocytopenia (ITP); Cohort 2 - primary warm autoimmune hemolytic anemia (wAIHA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (40)

Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale

Glendale, Arizona, 85304, United States

RECRUITING

Usc Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Rocky Mountain Cancer Centers

Lone Tree, Colorado, 80124, United States

NOT YET RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

Gnp Research

Cooper City, Florida, 33024, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031-4867, United States

NOT YET RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

NOT YET RECRUITING

Versiti Bloodcenter of Wisconsin Bcw Milwaukee

Milwaukee, Wisconsin, 53233, United States

NOT YET RECRUITING

St Vincent'S Hospital Sydney

Darlinghurst, New South Wales, 02010, Australia

RECRUITING

Townsville University Hospital

Douglas, Queensland, 04814, Australia

RECRUITING

Princess Alexandra Hospital Australia

Woolloongabba, Queensland, 04102, Australia

RECRUITING

Box Hill Hospital

Box Hill, Victoria, 03128, Australia

RECRUITING

Monash Medical Centre Clayton

Clayton, Victoria, 03168, Australia

NOT YET RECRUITING

The Alfred Hospital

Melbourne, Victoria, 03004, Australia

RECRUITING

Chu Angers - Hôpital Hôtel Dieu

Angers, 49933, France

NOT YET RECRUITING

Chu Caen - Hôpital de La Côte de Nacre

Caen, 14000, France

NOT YET RECRUITING

Hôpital Henri Mondor

Créteil, 94010, France

RECRUITING

Chu Dijon - Hopital Du Bocage

Dijon, 21079, France

RECRUITING

Chu Bordeaux - Hôpital Haut-Lévêque

Pessac, 33604, France

RECRUITING

Hopital Purpan

Toulouse, 31059, France

RECRUITING

Chru de Nancy- Hopital de Brabois

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

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

Bologna, 40138, Italy

RECRUITING

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

Brescia, 25123, Italy

RECRUITING

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

Meldola, 47014, Italy

RECRUITING

Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Ospedale San Raffaele

Milan, 20132, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Federico Ii

Naples, 80131, Italy

NOT YET RECRUITING

Azienda Ospedale Universita Di Padova

Padova, 35128, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Roma, 00136, Italy

RECRUITING

Amsterdam Umc, Locatie Vumc

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Radboudumc

Nijmegen, 6500 HB, Netherlands

RECRUITING

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

NOT YET RECRUITING

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Ico Badalona - Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Castle Hill Hospital

Cottingham, HU16 5JQ, United Kingdom

RECRUITING

Barts Hospital

London, E1 2ES, United Kingdom

RECRUITING

Plymouth Hospitals Nhs Trust

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Related Links

• Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): September 23, 2027
• Study Completion (Estimated): March 9, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

US (10); NL (4); AU (6); GB (3); FR (7); IT (8); ES (2)