Treatment for Antiphospholipid Syndrome with Thrombocytopenia using Anti-CD38 Antibody

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

This study is testing if a new antibody treatment can help people with antiphospholipid syndrome and low platelet counts who haven't had success with other therapies.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: rituximab, fizumatumumab, daratumumab
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT05983952 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of an anti-CD38 antibody in patients with antiphospholipid syndrome (APS) who also have thrombocytopenia and have not responded adequately to first-line and at least one second-line therapy. APS is an autoimmune disorder that can lead to recurrent blood clots and other complications. The trial aims to determine if the anti-CD38 antibody can provide a new treatment option for these patients. Participants must meet specific criteria, including a low platelet count and prior treatment failures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with antiphospholipid syndrome and experiencing thrombocytopenia despite previous treatments.

Not a fit: Patients with uncontrolled primary diseases of major organs or those who have previously received anti-CD38 antibody treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with APS and thrombocytopenia who have not responded to existing therapies.

How similar studies have performed: While there is ongoing research in the field of APS treatments, the use of anti-CD38 antibodies for this specific condition is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Tianjin, Tianjin Municipality

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

Study contacts

• Principal investigator: Lei Zhang, MD — Chinese Academy of Medical Science and Blood Disease Hospital
• Study coordinator: Yunfei Chen, MD

Conditions Antiphospholipid Syndrome; Thrombocytopenia