Status:
RECRUITING
Anti-CD38 Antibody Treating APS With Thrombocytopenia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Antiphospholipid Syndrome
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the safety and efficacy of anti-CD38 antibody in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in patients who have not responded adequately or relapsed after ...
Detailed Description
The anti-phospholipid syndrome (APS) is a systemic autoimmune disorder characterized by recurrent thrombosis and/or obstetrical morbidity along with persistent anti-phospholipid antibodies (APLA), inc...
Eligibility Criteria
Inclusion
- Age 18 and above, male or female.
- Conform to the diagnostic criteria of antiphospholipid syndrome (APS).
- Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab, CSA or CTX etc., or those who cannot chose other second-line therapy.
- Platelet count of \<30 X 10\^9/L.
- With normal hepatic and renal functions.
- ECOG physical state score ≤ 2 points.
- Cardiac function of the New York Society of Cardiac Function ≤ 2.
- Signed and dated written informed consent
Exclusion
- Received any treatment of anti-CD38 antibody drug
- 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;
- Those who have received allogeneic stem cell transplantation or organ transplantation in the past;
- Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;
- Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;
- 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;
- Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05983952
Start Date
August 1 2023
End Date
August 1 2025
Last Update
August 5 2025
Active Locations (1)
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1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020