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Clinical Trials in the UK / NCT07104565
Recruiting Phase 2

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

NCT07104565 · tracked via the Priya Life Science UK tracker
Sponsor
Incyte Corporation
Phase
Phase 2
Started
2025-12-29
Last updated
2026-09-14

Condition(s) studied

Immune Thrombocytopenia

Investigational drug(s) / intervention(s)

INCA000585

INCA000585: Tafasitamab will be administered intravenously at protocol defined timepoints.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale Glendale Arizona Recruiting
Usc Norris Comprehensive Cancer Center Los Angeles California Recruiting
Rocky Mountain Cancer Centers Lone Tree Colorado Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
Gnp Research Cooper City Florida Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Inova Schar Cancer Institute Fairfax Virginia Recruiting
Fred Hutchinson Cancer Center Seattle Washington Not Yet Recruiting
St Vincent'S Hospital Sydney Darlinghurst New South Wales Recruiting
Townsville University Hospital Douglas Queensland Recruiting
Princess Alexandra Hospital Australia Woolloongabba Queensland Recruiting
Box Hill Hospital Box Hill Victoria Recruiting
Monash Medical Centre Clayton Clayton Victoria Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Chu Angers - Hôpital Hôtel Dieu Angers France Recruiting
Chu Caen - Hôpital de La Côte de Nacre Caen France Recruiting
Hôpital Henri Mondor Créteil France Recruiting
Chu Dijon - Hopital Du Bocage Dijon France Recruiting
Chu Bordeaux - Hôpital Haut-Lévêque Pessac France Recruiting
Hopital Purpan Toulouse France Recruiting
Chru de Nancy- Hopital de Brabois Vandœuvre-lès-Nancy France Recruiting
Azienda Ospedaliero-Universitaria Orsola-Malpighi - Universita Degli Studi Di Bologna Bologna Italy Recruiting
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Montichiari) Brescia Italy Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Meldola Italy Recruiting
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico Milan Italy Recruiting
Ospedale San Raffaele Milan Italy Recruiting
Azienda Ospedaliera Universitaria Federico Ii Naples Italy Recruiting
Azienda Ospedale Universita Di Padova Padova Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma Italy Recruiting
Amsterdam Umc, Locatie Vumc Amsterdam Netherlands Recruiting
Radboudumc Nijmegen Netherlands Recruiting
Erasmus Medisch Centrum Rotterdam Netherlands Recruiting
University Medical Center Utrecht Utrecht Netherlands Recruiting
Ico Badalona. Hospital Universitario Germans Trias I Pujol Badalona Spain Recruiting
Hospital Universitario La Paz Madrid Spain Recruiting
Castle Hill Hospital Cottingham United Kingdom Recruiting
Barts Hospital London United Kingdom Recruiting
Plymouth Hospitals Nhs Trust Plymouth United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07104565 on ClinicalTrials.gov ↗ ← All trials in the UK