Anti-CD38 antibody for children with immune thrombocytopenia who did not respond to earlier treatment

Who can take part

• Age 6 years and above, male or female
• Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)
• Diagnosis of ITP ≥3 months, and with a platelet count of <30 X 10\^9/L measured within 2 days prior to inclusion
• Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPORAs
• The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration
• Signed and dated written informed consent
• With normal hepatic and renal functions
• ECOG physical state score ≤ 2 points
• Cardiac function of the New York Society of Cardiac Function ≤ 2
• Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg/kg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was>3 months；More than 6 months after splenectomy; March 26,2024 After approval by the Ethics Committee，age of subjects has been modified to 6 years and above upon enrollment. Approval Number: IIT2023072-EC-2

Who cannot take part

• Allergy to daratumumab or its excipients, or prior treatment with daratumumab that was refractory or achieved a response lasting <6 months；
• Those who have received allogeneic stem cell transplantation or organ transplantation in the past
• Patients taking antiplatelet drugs at the same time
• 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
• Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up
• 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 whose toxic symptoms caused by pre-trial treatment have not disappeared
• Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients