Anti-CD38 Antibody Treating APS With Thrombocytopenia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jul 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using an anti-CD38 antibody for patients with Antiphospholipid Syndrome (APS) who also have low platelet counts (thrombocytopenia). The goal is to find out if this treatment is safe and effective for people who haven't responded well to standard treatments, such as corticosteroids and other therapies like rituximab. The trial is currently seeking participants aged 18 and older, including both men and women, who have been diagnosed with APS and have a very low platelet count (below 30).

If you decide to participate, you will receive the anti-CD38 antibody treatment, and your health will be closely monitored to see how well it works and if there are any side effects. However, there are some important criteria to be aware of: you should not have any serious ongoing health issues, such as certain heart or liver problems, and you should not have received this specific treatment before. Participants will need to provide written consent and be in good physical condition to engage in the trial. This research could help improve treatment options for those struggling with APS and thrombocytopenia.

Gender

ALL

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 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.