INCA000585-201: A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants with Primary Autoimmune Blood Cell Disorders

• To determine the safety and tolerabilityof tafasitamab in participants with primary ITP or primary wAIHA. 
• To determine the efficacy of tafasitamab in participants with primary ITP. 
• To determine the efficacy of tafasitamab in participants with primary wAIHA. 
• To further determine the efficacy of tafasitamab in participants with primary ITP and primary wAIHA. 

For more information, please visit: https://clinicaltrials.gov/study/NCT07104565

Inova Schar Cancer
8081 Innovation Park Drive
Fairfax, VA 22031

• Aged ≥ 18 years.
• Confirmed historical diagnosis of one of the following autoimmune blood disorders:
  • Primary ITP.
  • Primary wAIHA.
• No history of splenectomy.
• Willingness to avoid pregnancy or fathering children.
• 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.

• 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.
• Women who are pregnant or breastfeeding.