NCT06014775 Anti-CD38 Antibody Treating Evans Syndrome

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 10 participants in total. It began in 2023-12-01 with a primary completion date of 2025-08.

Brief Summary

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.

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.

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