Anti-CD38 Antibody Treating Evans Syndrome

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Aug 25, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called Anti-CD38 Antibody for adults with Evans Syndrome, a condition where the body destroys its own blood cells, leading to low blood counts. The study is open to adults aged 18 and older who have not responded well to previous treatments or have relapsed after trying at least one other therapy. To qualify, participants need to have a very low platelet count or symptoms of anemia and should be in a state of active hemolysis, which means their blood cells are being destroyed.

If you decide to join this trial, you will receive the Anti-CD38 Antibody, and your health will be closely monitored to see how well the treatment works and if there are any side effects. It's important to note that certain health conditions or previous treatments might exclude you from participating, such as having serious heart or liver issues, recent infections, or if you've had certain types of blood or organ transplants. The trial aims to help improve treatment options for Evans Syndrome, and your involvement could contribute to important research in this area.

Gender

ALL

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.