A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Incyte Corporation
Summary
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 b…
Interventions
- DrugINCA000585
Tafasitamab will be administered intravenously at protocol defined timepoints.
Locations (40)
- Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd GlendaleGlendale, Arizona
- Usc Norris Comprehensive Cancer CenterLos Angeles, California
- Rocky Mountain Cancer CentersLone Tree, Colorado
- Yale University School of MedicineNew Haven, Connecticut
- Gnp ResearchCooper City, Florida
- Beth Israel Deaconess Medical CenterBoston, Massachusetts