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.
Adults 18 to 70 years of age, inclusive.
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.
Inability or unwillingness to give written informed consent.
Inability or unwillingness to comply with study protocol.
Systemic lupus erythematosus (SLE) meeting the EULAR/ACR classification criteria.
Rheumatoid arthritis meeting the ACR/EULAR classification criteria.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Immune Tolerance Network (ITN)
Collaborator
PPD Development, LP
Collaborator
Rho Federal Systems Division, Inc.
Collaborator