Daratumumab in Primary Antiphospholipid Syndrome (NCT05671757) | Clinical Trial Compass
RecruitingPhase 1/2
Daratumumab in Primary Antiphospholipid Syndrome
United States22 participantsStarted 2023-05-26
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adults 18 to 70 years of age, inclusive.
✓. The completion of the following vaccinations at least 14 days prior to Visit 0:
✓. At least one dose of the most recently updated COVID-19 vaccine, and
✓. At least one dose of the herpes zoster vaccination series, and
✓. Current seasonal influenza vaccine, if available.
✓. History of APS according to the updated 2006 Sapporo classification criteria, including at least one of the following:
✓. History of triple positive aPL within the prior 5 years and at least 12 weeks prior to enrollment, including all of the following:
✓. aCL IgG level \> Upper Limit of Normal (ULN), and
Exclusion criteria
✕. Inability or unwillingness to give written informed consent.
✕
What they're measuring
1
The proportion of participants in the dose escalation phase with at least one Dose Limiting Toxicity (DLT)
Timeframe: At or before week 9
Trial details
NCT IDNCT05671757
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)