A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
∙ \- Ability to comprehend and willingness to sign a written ICF for the study.
• Aged ≥ 18 years.
• Confirmed historical diagnosis of one of the following autoimmune blood disorders:
‣ Primary ITP.
⁃ Primary wAIHA.
• No history of splenectomy.
• 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.
• 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.
‣ Primary ITP: a PR (platelet count ≥ 30 × 109/L with at least a 2-fold increase of baseline platelet count) within 6 months of the last administered dose followed by relapse OR a CR (platelet count \> 100 × 109/L) lasting \< 48 weeks OR NR (platelet count \< 30 × 109/L or less than 2-fold increase of baseline platelet count or bleeding) within 6 months of the last administered dose.
⁃ Primary wAIHA: a PR with hemoglobin ≥ 10 g/dL and with an increase of at least 2 g/dL from baseline OR a CR (hemoglobin ≥ 12 g/dL and normalization of hemolytic markers) OR NR (hemoglobin \< 10 g/dL or \< 2 g/dL increase of baseline hemoglobin).
• Persistent or chronic active primary ITP or active primary wAIHA with indication for treatment at the time of inclusion.
‣ Primary ITP: platelet count \< 30 × 109/L within the 15 days before treatment is scheduled to begin (Day 1).
∙ Note: Participants treated with a rescue therapy during screening in response to a documented platelet count \< 30 × 109/L are eligible, irrespective of platelet count within 15 days of Day 1.
∙ • Primary wAIHA: hemoglobin \< 10 g/dL documented with DAT result positive for IgG, with or without C3d, and evidence of hemolysis based on low haptoglobin, elevated LDH, and/or indirect bilirubin.
• ECOG performance status of 0 to 2.
• Willingness to avoid pregnancy or fathering children.
• Further inclusion criteria apply.