Targeting the B Cell Response to Treat Antibody-Mediated Rejection With Carfilzomib and Belatacept (CarBel)
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
The purpose of this study is to evaluate the safety and efficacy of carfilzomib and belatacept, administered with steroids and maintenance immunosuppression, in kidney transplant recipients with donor-specific antibody (DSA)-associated graft injury. Participants will be followed for 52 weeks after starting investigational therapy, including protocol biopsies at 3 months and 12 months after start of investigational therapy. The study will also assess changes in immune cell responses, blood and urine biomarkers, and biopsy-based pathomic features associated with antibody-mediated graft injury.
Description
This is a prospective, multicenter, open-label study evaluating the safety and efficacy of carfilzomib and belatacept in kidney transplant recipients with donor-specific antibody-associated graft injury. Twenty-five participants will receive steroid pulse/taper, carfilzomib, belatacept, tacrolimus, mycophenolate, and prednisone according to protocol-defined dosing and maintenance immunosuppression. Participants will be followed for 12 months after initiation of investigational therapy, with protocol biopsies performed at 3 months and 12 months after start of investigational therapy. Participan…