Actively Recruiting
Anti-CD38 Antibody Treating Evans Syndrome
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-21
10
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti-CD38 Antibody Treating Evans Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years
- Clinical diagnosis of primary Evans syndrome before enrollment
- Platelet count less than 30 x 10^9/L or hemoglobin less than 100 g/L or symptomatic anemia within 48 hours before first dose
- Lack of response or relapse after corticosteroids and at least one second-line therapy or no suitable second-line therapy
- Emergency treatment for Evans syndrome stopped more than 2 weeks before first dose
- Positive direct antiglobulin test (IgG+, with or without C3+)
- Active hemolysis at enrollment
- Normal liver and kidney function
- ECOG performance status of 2 or less
- Cardiac function New York Heart Association class 2 or less
- Stable corticosteroid dose for at least 2 weeks before first dose if on maintenance treatment
- TPO receptor agonists and certain immunosuppressants stopped at least 4 weeks before first dose
- Anti-CD20 antibody treatment ended more than 6 months prior
- Alkylating agent treatment ended more than 2 months prior
- Able to understand study procedures and provide informed consent
You will not qualify if you...
- Secondary Evans syndrome
- Previous treatment with any anti-CD38 antibody drug
- Uncontrolled major organ diseases including cancer, liver failure, heart failure, or kidney failure
- HIV positive
- Active uncontrolled infections including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or syphilis
- Severe bleeding such as hemoptysis, gastrointestinal hemorrhage, or intracranial hemorrhage
- Heart disease, arrhythmias requiring treatment, or poorly controlled hypertension
- Thrombotic diseases including pulmonary embolism, thrombosis, or atherosclerosis
- History of allogeneic stem cell or organ transplantation
- Mental disorders preventing informed consent or participation
- Persistent toxic symptoms from prior treatments
- Other serious diseases limiting study participation such as diabetes, severe cardiac insufficiency, recent unstable angina or arrhythmia, gastric ulcer
- Septicemia or other irregular severe bleeding
- Current use of antiplatelet drugs
- Pregnant or breastfeeding women, or positive pregnancy test at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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