A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Evans Syndrome
A single-center, open-label, off-label use investigator-initiated clinical study with safety run-in to explore the clinical activity and safety of Anti-CD38 Antibody in adult ES patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including immunosuppressive agents, Anti-CD20 Antibody and/or TPO-RA, or those in whom no other second-line treatment options are suitable.
• Male or female aged ≥18 years.
• Prior to enrollment, a clinical diagnosis of primary Evans syndrome was made.
• Platelet count \< 30×10\^9/L or Hb \< 100g/L or symptomatic anemia within 48 hours before the first administration of study drug;
• Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy or those who cannot chose other second-line therapy;
• If receiving emergency care for ES, treatment should be stopped \>2 weeks before first dose.
• DAT positive (IgG+, with or without C3+).
• The patient need to be in the state of active hemolysis.
• With normal hepatic and renal functions.
• ECOG performance status ≤2.
• Cardiac function: New York Heart Association functional class ≤2.
• For patients receiving maintenance treatment, corticosteroids must have a stable dose at least 2 weeks before the first administration, TPO receptor agonists and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of anti-CD20 antibody treatment was\>6 months.The end of alkylating agent treatment was\>2 months.
• Understand the study procedures and voluntarily sign the informed consent form in person.