Anti-CD38 Antibody Treating Evans Syndrome

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China
• Treatments: Antibodies

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.