A Prospective, One-arm Open Clinical Study Evaluating Anti-CD38 Antibody for Antiphospholipid Syndrome With Secondary Thrombocytopenia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an anti-CD38 antibody treatment for patients with antiphospholipid syndrome (APS) who also have secondary thrombocytopenia. This study focuses on patients who have not responded well or have relapsed after first-line treatment and at least one second-line therapy, including rituximab or thrombopoietin receptor agonists. APS is an autoimmune disorder that causes blood clots and pregnancy complications, associated with certain antibodies that increase clotting risk. Thrombocytopenia, a low platelet count, occurs in many APS patients and increases bleeding risk, making treatment challenging. The study involves a single group of 10 participants who will receive intravenous anti-CD38 antibody infusions at a dose of 16 mg/kg once a week for 8 weeks. This initial treatment phase is followed by a 16-week observation period to monitor the ongoing safety and continued effect of the antibody after treatment ends. The anti-CD38 antibody targets plasma cells and has been used in other autoimmune conditions and blood cancers, with early reports suggesting it may reduce antibody levels and improve platelet counts in APS. During the study, participants will be closely monitored for treatment response and safety. Researchers will assess platelet counts, antibody levels, bleeding episodes, and any clotting events. The primary goal is to evaluate how well participants respond to the treatment within 8 weeks and to observe safety for up to 24 weeks. Additional measures include time to platelet improvement, duration of response, and immune cell changes. This study offers an opportunity to explore a new therapeutic option for difficult-to-treat APS with thrombocytopenia over a total participation period of about 24 weeks.

Anti-CD38 Antibody Treating APS With Thrombocytopenia