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RECRUITING
NCT06918990
PHASE1

Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-05-29

Completion Date

2027-06-30

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

Carfilzomib

Administered by intravenous infusion over 60 minutes.

BIOLOGICAL

Belatacept

Administered by intravenous infusion over 30 minutes.

Locations (10)

University of Alabama Medical Center

Birmingham, Alabama, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

UCLA Medical Center (Site #: 71123)

Los Angeles, California, United States

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, United States

Washington University

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

Duke University

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States