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 see: 1. If using these two drugs (carfilzomib and belatacept) together is safe 2. If the use of these two study drugs in addition to the usual immunosuppression for kidney transplant patients can improve your transplanted kidney function by lowering the antibodies you have against your transplanted kidney 3. If the study drugs effect the immune cells that were responding to your donor kidney. And, whether blood or urine tests can measure signs of inflammation and kidney cell injury 4. If using new computer techniques can help describe important changes seen on biopsy in your donated kidneys The primary objective is to assess the efficacy of carfilzomib and belatacept therapy when added to current treatment with steroids and maintenance immunosuppression, compared to conventional treatment alone, to improve the clinical outcome in renal transplant patients with donor-specific antibody (DSA) and associated graft injury occurring more than 6 months after renal transplantation or less than 6 months post-transplant.
Description
Enrollment Update (March 2026): The CTOT-42 Oversight Team has implemented a voluntary temporary hold on enrollment and randomization in the CarBel study while Protocol Version 2.0 and associated informed consent documents undergo review by the U.S. Food and Drug Administration (FDA) and the Duke University Health System Institutional Review Board (IRB). Enrollment is expected to begin following IRB review and approval of the protocol amendment.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able to understand and agree to participate in the study. 2. Have received a kidney transplant from a living or deceased donor (including re-transplants). 3. 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. 4. Heart function must be good enough (LVEF of at least 40%) without severe heart issues or high blood pressure in the lungs. 5. Must have been previously exposed to the Epstein-Barr Virus (EBV). 6. Diagnosed with specific types of kidney transplant rejecti…
Interventions
- BiologicalCarfilzomib
Administered by intravenous infusion over 60 minutes.
- BiologicalBelatacept
Administered by intravenous infusion over 30 minutes.
Locations (9)
- University of Alabama Medical CenterBirmingham, Alabama
- Mayo Clinic ArizonaPhoenix, Arizona
- Northwestern University, Feinberg School of MedicineChicago, Illinois
- Washington UniversitySt Louis, Missouri
- NYU Langone HealthNew York, New York
- Duke UniversityDurham, North Carolina