Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05983952

PHASE2

Anti-CD38 Antibody Treating APS With Thrombocytopenia

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

Official title: A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-08-01

Completion Date

2025-08

Last Updated

2025-08-05

Healthy Volunteers

Conditions

Antiphospholipid Syndrome Thrombocytopenia

Interventions

DRUG

Anti-CD38 antibody Injection

intravenous Anti-CD38 antibody administration This study adopts a prospective, single arm, open design method. Ten subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg/kg/w) for 8 weeks. The first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment. The second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment.

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 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.

Locations (1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China