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NCT07104565PHASE2Recruiting

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

Incyte Corporation

Start Date

12/29/2025

Completion Date

3/9/2028

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

INCA000585

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Conditions

Immune Thrombocytopenia

Locations

Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale

Glendale, Arizona 85304

United States

Usc Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado 80124

United States

Yale University School of Medicine

New Haven, Connecticut 06510-3221

United States

Gnp Research

Cooper City, Florida 33024

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Inova Schar Cancer Institute

Fairfax, Virginia 22031-4867

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Versiti Bloodcenter of Wisconsin Bcw Milwaukee

Milwaukee, Wisconsin 53233

United States

St Vincent'S Hospital Sydney

Darlinghurst, New South Wales 02010

Australia

Townsville University Hospital

Douglas, Queensland 04814

Australia

Princess Alexandra Hospital Australia

Woolloongabba, Queensland 04102

Australia

Box Hill Hospital

Box Hill, Victoria 03128

Australia

Monash Medical Centre Clayton

Clayton, Victoria 03168

Australia

The Alfred Hospital

Melbourne, Victoria 03004

Australia

Chu Angers - Hôpital Hôtel Dieu

Angers, 49933

France

Chu Caen - Hôpital de La Côte de Nacre

Caen, 14033

France

Hôpital Henri Mondor

Créteil, 94010

France

Chu Dijon - Hopital Du Bocage

Dijon, 21079

France

Chu Bordeaux - Hôpital Haut-Lévêque

Pessac, 33604

France

Hopital Purpan

Toulouse, 31059

France

Chru de Nancy- Hopital de Brabois

Vandœuvre-lès-Nancy, 54500

France

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

Bologna, 40138

Italy

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

Brescia, 25123

Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

Meldola, 47014

Italy

Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20122

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Azienda Ospedaliera Universitaria Federico Ii

Naples, 80131

Italy

Azienda Ospedale Universita Di Padova

Padova, 35128

Italy

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Roma, 00136

Italy

Amsterdam Umc, Locatie Vumc

Amsterdam, 1105 AZ

Netherlands

Radboudumc

Nijmegen, 6500 HB

Netherlands

Erasmus Medisch Centrum

Rotterdam, 3015 GD

Netherlands

University Medical Center Utrecht

Utrecht, 3584 CX

Netherlands

Ico Badalona. Hospital Universitario Germans Trias I Pujol

Badalona, 08916

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Castle Hill Hospital

Cottingham, HU16 5JQ

United Kingdom

Barts Hospital

London, E1 2ES

United Kingdom

Plymouth Hospitals Nhs Trust

Plymouth, PL6 8DH

United Kingdom