Condition: Autoimmune Disorders · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Johns Hopkins University | Baltimore, Maryland, United States | Recruiting |
| University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
| Mayo Clinic Rochester | Rochester, Minnesota, United States | Completed |
| Northwell Health | Great Neck, New York, United States | Recruiting |
| NYU Langone | New York, New York, United States | Recruiting |
| Hospital for Special Surgery | New York, New York, United States | Recruiting |
| Weill Cornell | New York, New York, United States | Recruiting |
| Duke University | Durham, North Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05671757