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First received: December 20, 2022

Clinical Trial: Daratumumab in Primary Antiphospholipid Syndrome

Study Status: Completed

Recruit Status: RECRUITING

Condition: Autoimmune Disorders

Study Type: INTERVENTIONAL


Official Title: Targeting CD38 With Daratumumab in Primary Antiphospholipid Syndrome: A Phase 1b Dose Escalation Safety Trial (ITN093AI)

Brief Summary: The purpose of this study is to see if the study medication, daratumumab, is safe to treat individuals with Anti-Phospholipid Syndrome (APS).Three daratumumab dosing cohorts are planned with up to six participants in each dosing cohort with the potential to enroll an additional 4 subjects in the highest safe dose (HSD) cohort, for a total of up to 22 participants.The dosing cohorts are: 4 mg/kg, 8 mg/kg, and 16 mg/kg.Each cohort will receive intravenous (IV) administration of daratumumab according…

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