A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia
To evaluate the safety and efficacy of anti-CD38 antibody in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including rituximab and/or TPO-RA.
• Age 18 and above, male or female.
• Conform to the diagnostic criteria of antiphospholipid syndrome (APS).
• Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab, CSA or CTX etc., or those who cannot chose other second-line therapy.
• Platelet count of \<30 X 10\^9/L.
• With normal hepatic and renal functions.
• ECOG physical state score ≤ 2 points.
• Cardiac function of the New York Society of Cardiac Function ≤ 2.
• Signed and dated written informed consent