Anti-CD38 Antibody Treating Evans Syndrome (2023-D-ES)
Evan Syndrome, Treatment
About this trial
This is an interventional treatment trial for Evan Syndrome
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Secondary Evans syndrome. Received any treatment of anti-CD38 antibody drug Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases; HIV positive; Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive; Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.; At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled; Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis; Those who have received allogeneic stem cell transplantation or organ transplantation in the past; Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up; Patients whose toxic symptoms caused by pre-trial treatment have not disappeared; Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.); Patients with septicemia or other irregular severe bleeding; Patients taking antiplatelet drugs at the same time; Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.
Sites / Locations
- Chinese Academy of Medical Science and Blood Disease HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Intervention(Anti-CD38 antibody)
10 enrolled subjects : once a week x 8 doses