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Looking for participantsPhase2

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

Sponsor: Incyte Corporation

NCT ID: NCT07104565

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
INCA000585 (drug)
How long the study runs
Study runs about 27 months (dates as stated)
About the drug or intervention
INCA000585 — drug: Tafasitamab will be administered intravenously at protocol defined timepoints.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
56
Started
2025-12-29
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for immune thrombocytopenia
  • • Phase2 - 56 participants
  • • This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with immune thrombocytopenia

Where?

  • • Cottingham - Castle Hill Hospital
  • • London - Barts Hospital
  • • Plymouth - Plymouth Hospitals Nhs Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Immune Thrombocytopenia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

PRresult positiveCD19Known positiveand a positivewith positivecase of negativepositivity or positive

What the study is looking for

  • ✓\- 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.

Who cannot take part

  • ✗Clinical manifestations typical for cold agglutinin disease.
  • ✗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.
  • ✗Evidence of hypogammaglobulinemia during screening (IgA \< 70 mg/dL, IgG \< 700 mg/dL, and/or IgM \< 40 mg/dL) and...
  • ✗Women who are pregnant or breastfeeding.
See the full criteria
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.

Where Is This Study? (3 UK sites)

Castle Hill Hospital

Cottingham HU16 5JQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Barts Hospital

London E1 2ES, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Plymouth Hospitals Nhs Trust

Plymouth PL6 8DH, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&D Manager

plh-tr.RD-office@nhs.net01752 431776

How to Get in Touch

Incyte Corporation Call Center (US)

Sponsor contact

CONTACT

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

Sponsor contact

CONTACT

+800 00027423 eumedinfo@incyte.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09