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Anti-CD38 Antibody Treating APS With Thrombocytopenia

StatusUnknown
PhasePhase 2
Started2023-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-06
Trial status changed: Recruiting → Unknown
2025-07-31
Study Status, Oversight, Outcome Measures v3
Trial statusRecruiting→Unknown
Primary endpoints2 entries, revised
To evaluate the efficacy after CM313anti-CD38 antibody treatment within 8 weeks
2025-02-20
Study Identification, Study Status, Sponsor/Collaborators v2
Start dateestimated 2023-08→confirmed 2023-08-01
2023-08-09
Study Identification, Study Status, Study Description, Conditions, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 12 entries
Primary endpoints2 entries, revised
To evaluate ofthe responseefficacy after anti-CD38 antibodyCM313 treatment at weekwithin 8 weeks
Study description+20 characters
[...] patients with antiphospholipid syndrome or IgG anti-β2GPI, weresearchers unfortunately could not build a nuanced model of how divers [...] of treating ITP patients with antiphospholipid antibodies, weinvestigators found that anti-CD38 antibody could not only rapidly increa [...]
Study title-93 characters
A Prospective, One-arm and Open Clinical Study of Anti-CD38 Antibody inTreating the Treatment of Antiphospholipid SyndromeAPS With Secondary Thrombocytopenia
2023-07-31
Original filing
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.
Trial Details
NCT Number NCT05983952
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Antiphospholipid Syndrome, Thrombocytopenia
Enrollment 10 participants
Start Date 2023-08-01
Primary Completion 2025-08 (estimated)
Study Completion 2025-08 (estimated)
Updated on ClinicalTrials.gov 2025-08-05