This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
Aged ≥ 18 years.
Primary ITP.
Primary wAIHA.
No history of splenectomy.
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.
Incyte Corporation
Lead sponsor