Actively Recruiting
Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-05
30
Participants Needed
1
Research Sites
104 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 primary immune thrombocytopenia in patients who have failed first-line treatment.
CONDITIONS
Official Title
Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to 18 years, male or female
- Diagnosed with primary immune thrombocytopenia for at least three months as per established guidelines
- Failed glucocorticoid therapy or unable to maintain response or relapsed after first-line treatment
- Platelet count below 30 x 10^9/L measured at least twice during screening with no counts above 35 x 10^9/L
- ECOG performance status score of 2 or less
- Stable maintenance therapy with only one medication such as glucocorticoids (up to 0.5 mg/kg prednisone or equivalent) or TPO receptor agonists for at least 4 weeks
- Negative pregnancy test for fertile females; use of effective contraception during and for 4-6 months after treatment
- Ability to understand and comply with study requirements and provide informed consent
You will not qualify if you...
- Allergy to anti-CD38 monoclonal antibody or previous anti-CD38 antibody treatment with poor or short response
- Secondary thrombocytopenia or autoimmune hemolytic anemia
- History of blood clots, severe bleeding, sepsis, or irregular bleeding within 12 months before treatment
- Participation in other investigational drug studies within 4 weeks or 5 half-lives before treatment
- Use of antiplatelet drugs within 3 weeks before treatment
- Emergency ITP treatments within 2 weeks before treatment
- Use of certain immunosuppressive drugs within 4 to 6 months before treatment
- Splenectomy within 6 months before treatment
- Receipt of live vaccines within 4 weeks before or planned during the study
- Diagnosis of myelodysplastic syndromes or recent malignancy within 5 years except certain cured cancers
- History of stem cell or organ transplantation
- Significant medical history posing safety risks, including recent heart conditions, severe asthma or COPD
- History of severe or recurrent infections or immunosuppression
- Abnormal lab results including liver enzymes, bilirubin, neutrophil count, hemoglobin, IgG, lymphocytes, or kidney function
- Positive tests for HIV, syphilis, hepatitis B or C under specified conditions
- Pregnancy, breastfeeding, or intention to conceive during the study
- Any other condition judged unsuitable by the investigator
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, 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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