NCT06918990

Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

Targeting the B Cell Response to Treat Antibody-Mediated Rejection With Carfilzomib and Belatacept (CarBel)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
BIOLOGICAL	Carfilzomib	Administered by intravenous infusion over 60 minutes.
BIOLOGICAL	Belatacept	Administered by intravenous infusion over 30 minutes.

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-04-09
• Last updated: 2026-03-10

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study