Clinical Trial

The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia

Study acronym: DARA-AA-001
Not Yet Recruiting Phase 1/2
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Summary
This study consists of two phases, phase Ib and phase II. The primary objective of phase Ib is to evaluate the safety and tolerability of multiple doses of daratumumab in patients with refractory aplastic anemia. The primary objective of phase II is to preliminarily assess the efficacy of multiple doses of daratumumab in patients with refractory aplastic anemia. Secondary objectives include evaluation of other efficacy endpoints, safety (phase II), and pharmacodynamic characteristics of multiple doses of daratumumab in these patients. The exploratory objective is to assess biological functional changes in peripheral blood and bone marrow before and after daratumumab treatment.
Trial Details
NCT Number NCT07287228
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Aplastic Anemia, Refractory, Relapse
Enrollment 37 participants
Start Date 2025-12-10
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-17