Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05983952

Anti-CD38 Antibody Treating APS With Thrombocytopenia

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-05

10

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Anti-CD38 Antibody Treating APS With Thrombocytopenia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 and above, male or female.
  • Meet the diagnostic criteria for antiphospholipid syndrome (APS).
  • Have not responded or have relapsed after corticosteroid therapy and at least one second-line therapy including rituximab, cyclosporine A, or cyclophosphamide, or cannot choose other second-line therapy.
  • Platelet count less than 30 x 10^9/L.
  • Normal liver and kidney function.
  • Eastern Cooperative Oncology Group (ECOG) physical state score of 2 or less.
  • New York Heart Association cardiac function class 2 or less.
  • Signed and dated informed consent form.
Not Eligible

You will not qualify if you...

  • Previous treatment with any anti-CD38 antibody drug.
  • Uncontrolled major organ diseases such as malignant tumors, liver failure, heart failure, or renal failure.
  • HIV positive.
  • Uncontrolled active infections including hepatitis B, hepatitis C, cytomegalovirus, Epstein-Barr virus, or syphilis.
  • Severe bleeding events such as hemoptysis, upper gastrointestinal bleeding, or intracranial hemorrhage.
  • Heart diseases, arrhythmias needing treatment, or poorly controlled hypertension.
  • History of thrombotic diseases including pulmonary embolism, thrombosis, or atherosclerosis.
  • Prior allogeneic stem cell or organ transplantation.
  • Mental disorders preventing informed consent or trial participation.
  • Persistent toxic symptoms from prior treatments.
  • Other serious diseases limiting participation (e.g., diabetes, severe cardiac insufficiency, recent unstable angina).
  • Septicemia or other severe irregular bleeding.
  • Pregnant or lactating women, or suspected pregnancy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

Y

Yunfei Chen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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