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Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

NCT07104565•Incyte Corporation

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+8 more criteria

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.
+20 more criteria

Locations (40)

Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale

Glendale, Arizona, United States

Usc Norris Comprehensive Cancer Center

Los Angeles, California, United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Gnp Research

Cooper City, Florida, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Montefiore Medical Center

The Bronx, New York, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Versiti Bloodcenter of Wisconsin Bcw Milwaukee

Milwaukee, Wisconsin, United States

Key Dates

Start Date

December 29, 2025

Primary Completion Date

September 23, 2027

Completion Date

March 9, 2028

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

Immune Thrombocytopenia

Interventions

INCA000585

DRUG

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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