Treatment of Antibody-Mediated Rejection (ABMR) With CarBel (NCT06918990) | Clinical Trial Compass
RecruitingPhase 1
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
United States25 participantsStarted 2026-05-29
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Must have been previously exposed to the Epstein-Barr Virus (EBV).
. Diagnosed with specific types of kidney transplant rejection based on criteria, with certain conditions on timing and treatment history.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 3-months post randomization and 12-months post receipt of Investigational Therapy (IT)
2
Proportion of subjects achieving either (1) ≥50% reduction in MFI or clearance below positivity threshold of immunodominant DSA, or (2) >20% improvement in 12-month post-treatment eGFR slope vs pre-enrollment
Timeframe: 3-months post randomization and 12-months post receipt of IT
Trial details
NCT IDNCT06918990
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)