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.
Parallel
INCA000585
DrugTafasitamab will be administered intravenously at protocol defined timepoints.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as any adverse event, either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug.
Stable platelet response
Defined as platelet count ≥ 50 × 109/L in the absence of clinically significant bleeding or rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary ITP.
Stable hemoglobin response
Defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline in the absence of rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary wAIHA.
Complete Response (CR)
Defined as platelet count ≥ 100 × 109/L at Week 24 in the absence of clinically significant bleeding or rescue therapy in participants with primary ITP.
CR (complete remission)
Defined as platelet count ≥ 100 × 109/L at Week 48 in the absence of clinically significant bleeding or rescue therapy in participants with primary ITP.
Partial Response (PR)
Defined as platelet count ≥ 30 × 109/L and at least a 2-fold increase of baseline platelet count at Week 24 in the absence of clinically significant bleeding or rescue therapy in participants with primary ITP.
Duration of stable platelet response
Defined as time from start of stable platelet response to loss of platelet response (\< 50 × 109/L), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first in participants with primary ITP.
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