NCT05983952 Anti-CD38 Antibody Treating APS With Thrombocytopenia
| NCT ID | NCT05983952 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Antiphospholipid Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2025-08 |
Trial Parameters
Eligibility Fast-Check
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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 first-line treatment and at least one second-line therapy including rituximab and/or TPO-RA.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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