Anti-CD38 Antibody Treating APS With Thrombocytopenia

Recruiting now · Phase 2

Conditions studied: Antiphospholipid Syndrome, Thrombocytopenia

In brief

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.

Key facts

Study ID: NCT05983952
Run by: Institute of Hematology & Blood Diseases Hospital, China
People needed: 10
Starts: 2023-08-01
Expected to finish: 2025-08-01
Last updated by the study team: 2025-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Chinese Academy of Medical Science and Blood Disease Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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