RecruitingPhase 1NCT06918990

Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

25 participants

Start Date

May 27, 2026

Study Type

INTERVENTIONAL

Conditions

Kidney Transplant Rejection

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Belatacept and a biological treatment called Carfilzomib for people with kidney transplant rejection. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCarfilzomib

Administered by intravenous infusion over 60 minutes.

BIOLOGICALBelatacept

Administered by intravenous infusion over 30 minutes.

Locations(11)

University of Alabama Medical Center (Site # 71136)

Birmingham, Alabama, United States

Mayo Clinic Arizona (Site # 71144)

Phoenix, Arizona, United States

UCLA Medical Center (Site #: 71123)

Los Angeles, California, United States

Northwestern University, Feinberg School of Medicine (Site # 71110)

Chicago, Illinois, United States

Washington University (Site # 71157)

St Louis, Missouri, United States

NYU Langone Health (Site # 71177)

New York, New York, United States

Duke University (Site # 71139)

Durham, North Carolina, United States

Christ Hospital (Site # 71195)

Cincinnati, Ohio, United States

University of Cincinnati (Site # 71118)

Cincinnati, Ohio, United States

Cleveland Clinic (Site # 71101)

Cleveland, Ohio, United States

University of Wisconsin Madison (Site # 71112)

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06918990

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