Actively Recruiting
Anti-CD38 Antibody Treating Elderly Patients With Primary Immune Thrombocytopenia (ITP)
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-07-14
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of elderly patients with primary immune thrombocytopenia in patients who have failed multiple treatment.
CONDITIONS
Official Title
Anti-CD38 Antibody Treating Elderly Patients With Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older, male or female
- Diagnosed with primary immune thrombocytopenia for at least 3 months according to established guidelines
- Have failed glucocorticoid therapy and at least one standard second-line therapy
- History of response to previous first-line ITP therapy (glucocorticoids and/or intravenous human immunoglobulin)
- Platelet count below 30 × 10⁹/L within 24 hours before first study drug administration
- Average platelet count below 30 × 10⁹/L during screening with no count above 35 × 10⁹/L
- ECOG performance status score of 2 or less
- Maintenance therapy allowed if stable for at least 4 weeks prior to first dose
- Negative pregnancy test for fertile females; effective contraception required for fertile females and males during study and for 4-6 months after
- Ability to understand and adhere to study protocol and willing to sign informed consent
You will not qualify if you...
- Allergy to anti-CD38 monoclonal antibody or excipients, or previous use with poor or short response
- Secondary thrombocytopenia or autoimmune hemolytic anemia
- History of severe bleeding, thrombotic or embolic events, sepsis, or irregular bleeding within 12 months before first medication
- Participation in any other investigational drug study within 4 weeks or 5 half-lives prior to first dose
- Use of antiplatelet drugs within 3 weeks before first dose
- Emergency ITP treatments within 2 weeks before first dose
- Use of certain immunosuppressive drugs within 4 to 6 months before first dose
- Splenectomy within 6 months before first dose
- Live vaccines within 4 weeks before or planned during study
- Diagnosed myelodysplastic syndromes or recent malignancy within 5 years (except certain cured cancers)
- History of allogeneic stem cell or organ transplantation
- Significant medical history posing safety risks, including serious heart, lung, immune, or metabolic diseases
- Severe or chronic infections or acute infections requiring systemic treatment within 4 weeks before first dose
- Known or suspected immunosuppression or recurrent infections
- Laboratory abnormalities such as elevated liver enzymes, low hemoglobin, low immune globulin, low lymphocytes, or reduced kidney function
- Positive for HIV, syphilis, hepatitis B or C infections unless controlled
- Pregnant or breastfeeding women and male partners planning pregnancy during study
- Any other conditions deemed unsuitable by investigators
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, 301600
Actively Recruiting
Research Team
T
Ting Sun, MD
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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