This is a pilot, safety and efficacy trial of a combination of daratumumab and belatacept to
achieve desensitization in prospective kidney transplant recipients with cPRA >95.0%.
Eligible subjects will receive 6 infusions of daratumumab (8 mg/kg) and 4 infusions of
belatacept (10 mg/kg) over 10 weeks. All subjects will undergo human leukocyte antigen (HLA)
antibody assessments and bone marrow aspiration prior to and after completion of treatment,
and receive 26 weeks of follow up after completing treatment. Subjects who receive a kidney
transplant while in the study will receive protocol-directed immunosuppression and undergo
additional 52 weeks of follow up.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Bristol-Myers Squibb Immune Tolerance Network (ITN) PPD Rho Federal Systems Division, Inc.
Treatments:
Abatacept Daratumumab Immunoglobulin G Immunoglobulins