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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation

About this trial

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

Eligibility criteria

Qualifiers

Aged ≥ 18 years.

Primary ITP.

Primary wAIHA.

No history of splenectomy.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • INCA000585

Treatment groups

56 Participants
are divided into 2 treatment groups

Sponsors and collaborators