Actively Recruiting
Daratumumab in Primary Antiphospholipid Syndrome
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-02
22
Participants Needed
8
Research Sites
196 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
I
Immune Tolerance Network (ITN)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to see if the study medication, daratumumab, is safe to treat individuals with Anti-Phospholipid Syndrome (APS). Three daratumumab dosing cohorts are planned with up to six participants in each dosing cohort with the potential to enroll an additional 4 subjects in the highest safe dose (HSD) cohort, for a total of up to 22 participants. The dosing cohorts are: 4 mg/kg, 8 mg/kg, and 16 mg/kg. Each cohort will receive intravenous (IV) administration of daratumumab according to the following schedule, for a total of 8 doses. The primary objective is to determine the safety of daratumumab in APS defined as Dose Limiting Toxicities (DLTs) occurring during the dose escalation phase.
CONDITIONS
Official Title
Daratumumab in Primary Antiphospholipid Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 70 years of age, inclusive
- Completed at least one dose of updated COVID-19 vaccine, herpes zoster vaccine, and current seasonal influenza vaccine at least 14 days before study start
- History of APS per 2006 Sapporo criteria, including arterial thrombosis, venous thrombosis, pregnancy morbidity, or microvascular APS with biopsy confirmation
- History of triple positive antiphospholipid antibodies within prior 5 years and at least 12 weeks before enrollment
- Confirmation of triple positive antiphospholipid antibodies at screening with specified antibody levels
- Receiving anticoagulation with warfarin or low molecular weight heparin if history of thrombosis
You will not qualify if you...
- Unable or unwilling to provide written informed consent or comply with study protocol
- Systemic autoimmune diseases other than APS, including lupus, rheumatoid arthritis, or vasculitis
- Catastrophic APS within prior 90 days
- Acute arterial or venous thrombosis within prior 30 days
- Prior treatment with CD38 targeting monoclonal antibodies or recent use of certain immunosuppressive or immunomodulatory medications
- Plasma exchange or hemodialysis within prior 90 days
- Major surgery within prior 60 days
- Known allergy or intolerance to study drugs or related substances
- Active or chronic infections including HIV, hepatitis B or C, tuberculosis, or recurrent herpes zoster
- Specified laboratory abnormalities including low neutrophil count, low platelets, low hemoglobin, liver enzyme or bilirubin elevations, or low kidney function
- History of primary immunodeficiency or organ transplantation
- Comorbidities requiring systemic corticosteroids or certain lung diseases with reduced lung function
- Pulmonary hypertension, adrenal insufficiency, or poorly controlled diabetes
- Current or past malignancy except certain treated skin or cervical cancers
- Significant cardiac disease or recent myocardial infarction
- Diagnosed mental illness or substance abuse interfering with participation
- Severe uncontrolled diseases affecting major organs
- Any other medical issues posing risk or interfering with study
- Lack of peripheral venous access
- Pregnancy, breastfeeding, or unwillingness to use acceptable contraception during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Completed
4
Northwell Health
Great Neck, New York, United States, 11021
Actively Recruiting
5
NYU Langone
New York, New York, United States, 10016
Actively Recruiting
6
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
7
Weill Cornell
New York, New York, United States, 10021
Actively Recruiting
8
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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