drugset / Trial / NCT05671757
Daratumumab in Primary Antiphospholipid Syndrome
Phase 1/2
Recruiting
22 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collabPPD Development, LP · collabRho Federal Systems Division, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-05-26
- Primary completion
- 2026-06-24
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |