Daratumumab in Primary Antiphospholipid Syndrome

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT05671757
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Autoimmune Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — BIOLOGICAL
    Participants will receive 4 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
  • Daratumumab — BIOLOGICAL
    Participants will receive 4-8 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
  • Daratumumab — BIOLOGICAL
    Participants will receive 4-16 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48

Study Details

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.

Key Dates

Start date
May 26, 2023
Status verified
Mar 2026
Primary completion
Jun 24, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4 mg/kg Cohort
    This cohort will receive intravenous (IV) administration of 4 mg/kg daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
  • Experimental: 8 mg/kg Cohort
    This cohort will receive intravenous (IV) administration of 8 mg/kg daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
  • Experimental: 16 mg/kg Cohort
    This cohort will receive intravenous (IV) administration of 16 mg/kg daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48

Primary Outcome Measure

The proportion of participants in the dose escalation phase with at least one Dose Limiting Toxicity (DLT) [ Time Frame: At or before week 9 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205
Goodness Che
[email protected]
443-457-8241
Shruti Chaturvedi (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Sarosh Cyrus
[email protected]
734-647-5644
Jason Knight (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905-
Northwell HealthGreat NeckNew York11021
Radha Puran
[email protected]
516-708-2558
Nina Kello (PRINCIPAL_INVESTIGATOR)
Hospital for Special SurgeryNew YorkNew York10021
JoAnn Vega
[email protected]
212-774-2795
Doruk Erkan (PRINCIPAL_INVESTIGATOR)
NYU LangoneNew YorkNew York10016
Thomas Chalothron
[email protected]
646-501-7384
Sean Yi
[email protected]
646-601-7383
Michael Belmont, MD (PRINCIPAL_INVESTIGATOR)
Weill CornellNew YorkNew York10021
Nicole Santos
[email protected]
646-962-6827
Maria De Sancho (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Kristin Byrne
[email protected]
919-681-2668
Thomas Ortel, MD (PRINCIPAL_INVESTIGATOR)

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