The purpose of this study is to evaluate the safety 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.
Able to understand and agree to participate in the study.
Have received a kidney transplant from a living or deceased donor (including re-transplants).
Men and women must agree to use birth control during the study and for 3 months after the last dose of study drugs, or be surgically sterile or post-menopausal.
Heart function must be good enough (LVEF of at least 40%) without severe heart issues or high blood pressure in the lungs.
Unable or unwilling to give consent or follow study rules.
Kidney transplant with incompatible blood types.
Very high levels of protein in urine, indicating severe kidney issues.
Previously had a non-kidney organ or bone marrow transplant.
Single group
Carfilzomib
Biological/VaccineAdministered by intravenous infusion over 60 minutes.
Belatacept
Biological/VaccineAdministered by intravenous infusion over 30 minutes.
Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following: Grade 3 or higher infusion reaction, Grade 3 or higher infections, and any malignancy excluding localized non-melanomatous skin cancer.
Change in albuminuria
Change in Banff lesion grading score (2022 criteria)
Change in donor-specific antibody (DSA) MFI
Change in estimated Glomerular Filtration Rate (eGFR) (2022 criteria)
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