A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders (NCT07104565)

To determine the safety and tolerability of 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.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Huyen Tran

Key inclusion data

INCLUSION Criteria: Confirmed historical diagnosis of one of the following autoimmune blood disorders: Primary ITP: isolated thrombocytopenia (peripheral blood count < 100 × 109/L) in the absence of other causes or disorders associated with isolated thrombocytopenia. Participants must have persistent (3- to 12-month duration) or chronic (> 12-month duration) ITP. OR Primary wAIHA: isolated anemia and DAT result positive for IgG, with or without C3d, not due to another cause. Confirmed transient response to at least 1 prior early-line treatment (eg, corticosteroids,IVIG, rituximab). Received ≥ 1 standard course of rituximab (375 mg/kg × 4 weekly doses or 2 doses of 1000 mg flat dose every 2 weeks) with last dose given at least 6 months prior to initiation of study treatment. Note: If rituximab was the only prior therapy, individuals with NR to rituximab will not be eligible. EXCLUSION Criteria: 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. Previous severe allergic reaction to a mAb or known allergy to any component/excipient of tafasitamab. Receipt of medications or investigational drugs for primary ITP/wAIHA within the following interval before the first administration of study drug. Changes in doses (> 10%) of permitted disease-related therapies (see Section 6.6.1), including oral corticosteroids and TPO-RA (primary ITP participants) within 2 weeks prior to Day 1, or change in ESA (primary wAIHA participants) dose within 2 weeks prior to Day 1.