Actively Recruiting
A Prospective, Open-Label Study to Assess Safety and Efficacy of Anti-CD38 Antibody in Adults with Evans Syndrome
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-21
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and biological activity of Anti-CD38 antibody treatment in adults with primary Evans Syndrome (ES) who have not responded well or have relapsed after first-line and at least one second-line therapy. ES is a rare autoimmune condition involving destruction of red blood cells and platelets, often treated with corticosteroids and other therapies, but with a higher mortality rate than isolated autoimmune cytopenias. This study aims to explore a new treatment option targeting plasma cells that produce harmful antibodies in refractory cases. Participants will receive intravenous infusions of Anti-CD38 antibody at a dose of 16 mg/kg once a week for 8 weeks. This single-center, open-label study will enroll about 10 participants. After the 8-week treatment phase, there will be a follow-up period lasting until week 24 to assess continued safety and ongoing treatment effects. During the study, participants will be closely monitored with regular blood tests to measure platelet counts, hemoglobin levels, and markers of hemolysis such as reticulocyte count, LDH, haptoglobin, and bilirubin. Researchers will also assess response to treatment, bleeding events, fatigue, and overall health status. Safety will be evaluated throughout the treatment and follow-up periods. Total participation lasts approximately 24 weeks, including treatment and observation phases.
CONDITIONS
Brief Title
Anti-CD38 Antibody Treating Evans Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Clinical diagnosis of primary Evans Syndrome before enrollment
- Platelet count less than 30 x 10^9/L or hemoglobin below 100 g/L or symptomatic anemia within 48 hours before first study drug dose
- Failure to respond or relapse after corticosteroid therapy and at least one second-line therapy, or unsuitable for other second-line treatments
- Emergency treatment stopped more than 2 weeks before first dose
- Positive direct antiglobulin test (IgG+, with or without C3+)
- Active hemolysis present
- Normal liver and kidney function
- ECOG performance status 2 or lower
- Cardiac function New York Heart Association class 2 or lower
- Stable corticosteroid dose for at least 2 weeks before first dose; other immunosuppressants stopped at least 4 weeks before first dose; anti-CD20 antibody treatment ended over 6 months ago; alkylating agent treatment ended over 2 months ago
- Able to understand study procedures and voluntarily sign informed consent
You will not qualify if you...
- Secondary Evans Syndrome
- Prior treatment with any anti-CD38 antibody
- Uncontrolled serious diseases of vital organs such as malignant tumors, liver failure, heart failure, or renal failure
- HIV positive
- Uncontrolled active infections including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or syphilis
- Severe bleeding events such as hemoptysis, gastrointestinal hemorrhage, or intracranial hemorrhage
- Current heart diseases, arrhythmias requiring treatment, or poorly controlled hypertension
- History of thrombotic diseases like pulmonary embolism, thrombosis, or atherosclerosis
- Previous allogeneic stem cell or organ transplantation
- Mental disorders preventing informed consent or trial participation
- Persistent toxic symptoms from prior treatment
- Other serious illnesses limiting study participation (e.g., diabetes, recent unstable cardiac conditions, gastric ulcer)
- Septicemia or severe irregular bleeding
- Concurrent use of antiplatelet drugs
- Pregnant, breastfeeding, or suspected pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive intravenous Anti-CD38 antibody once a week for 8 weeks to evaluate safety and efficacy of the treatment.
Weekly visits for 8 weeks (in-person)
Duration - 16 weeks
Participants are observed for safety and continuous efficacy after the treatment ends.
Periodic visits during 16 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
T
Ting Sun, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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