Kidney Transplant RejectionPhase 1CarBelNCT06918990
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
A Phase 1 study testing Carfilzomib and Belatacept in people with Kidney Transplant Rejection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Carfilzomib and Belatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 11 sitesUnited States
- Study dates
- 27 May 2026to 30 Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Kidney function must be at a certain level (eGFR of at least 30 ml/min/1.73 m²).
- Patient is ≥6-months post-transplant or is <6 months post-transplant but has documentation that they have been offered and/or received the local standard of care treatment prior to enrollment.
- Must have a measurable level of specific antibodies against the donor kidney (HLA DSA) with a certain intensity.
- Up-to-date vaccinations according to guidelines for transplant patients.
- Must have a negative tuberculosis (TB) test and chest x-ray before enrollment, no symptoms or known contact with TB, and not have recently traveled to or lived in areas with high TB rates. If previously infected with TB, must have completed treatment and have a recent negative chest x-ray.
- If previously infected with COVID-19, must be fully recovered for at least 21 days before joining the study. No COVID-19 test required for those without symptoms.
Who cannot join
- Unable or unwilling to give consent or follow study rules.
- Kidney transplant with incompatible blood types.
- Very high levels of protein in urine, indicating severe kidney issues.
- Previously had a non-kidney organ or bone marrow transplant.
- Any other medical issues that might increase risk, make following the study rules hard, or affect study results, as judged by the study doctor.
- Heart attack within the last year, uncontrolled chest pain, or signs of a recent heart problem on an ECG.
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- Severe heart failure (Class 3 or higher).
- Irregular heartbeats that can't be controlled with medication.
- Participants who are actively receiving any of the therapies listed below, or who have previously received these therapies without meeting the required washout period prior to the qualifying biopsy and donor-specific antibody (DSA) assessment:
- ≥4 weeks since last dose: IVIG (intravenous immunoglobulin), therapeutic plasma exchange (TPE)
- ≥6 weeks since last dose: Proteasome inhibitors
- ≥3 months since last dose: Eculizumab; lymphocyte-depleting agents (e.g., rabbit anti-thymocyte globulin, alemtuzumab); anti-CD20 agents
- ≥6 months since last dose: Anti-CD38 agents; anti-IL-6 agents
- Used any experimental drug not specified within the last 4 weeks or longer if the drug stays in the body longer.
- Serious medical or mental health issues that could interfere with the study.
- Cancer diagnosis or treatment within the past 2 years, except for certain skin cancers or cancers with a high cure rate.
- Known allergy to Captisol® (used in the study drug).
- Very low blood counts (hemoglobin, neutrophils, or platelets).
- Positive for HIV, Hepatitis B, or Hepatitis C, unless Hepatitis C was successfully treated.
- Severe infections needing treatment in the last 4 weeks.
- Specific kidney infection (BK nephropathy) or high levels of BK virus.
- Certain kidney biopsy results indicating other types of rejection or kidney diseases.
- Treated for a specific viral infection (CMV) in the last 90 days or resistant to certain CMV treatments.
- Received a live vaccine in the last 4 weeks.
- Severe liver disease or abnormal liver tests.
- Pregnant or breastfeeding women. Women who can become pregnant must have a negative pregnancy test or proof they are not pregnant.
- Any other significant medical condition that could interfere with the study according to the doctor.
- Kidney rejection within 6 months post-transplant without standard care.
- Confirmed severe protein levels in urine.
- Underwent certain treatments from the time of entry DSA result and biopsy screening.
- History of multiple unprovoked blood clots.
- Diagnosed with Atypical Hemolytic Uremic Syndrome (aHUS).
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
University of Alabama Medical Center (Site # 71136)
Birmingham, Alabama, 35294
Christy Taylor, 205-934-8717, christytaylor@uabmc.edu
- Recruiting
Northwestern University, Feinberg School of Medicine (Site # 71110)
Chicago, Illinois, 60611
Sarah Tryon, 312-926-1076, satah.tryon@nm.org
- Not yet recruiting
Christ Hospital (Site # 71195)
Cincinnati, Ohio, 45267
Karen Case, 513-585-1436, casekl@ucmail.uc.edu
- Recruiting
University of Cincinnati (Site # 71118)
Cincinnati, Ohio, 45267
Pam Ringo, 513-585-1436, ringopm@ucmail.uc.edu
- Recruiting
Cleveland Clinic (Site # 71101)
Cleveland, Ohio, 44195
Dianna Sendrey, 216-444-0486, sendred2@ccf.org
- Recruiting
Duke University (Site # 71139)
Durham, North Carolina, 27710
Kitza Williams, 919-681-1035, Kitza.williams@duke.edu
- Not yet recruiting
UCLA Medical Center (Site #: 71123)
Los Angeles, California, 90024
Ahad Qureshi, 310-794-8516, AhadQureshi@mednet.ucla.edu
- Recruiting
University of Wisconsin Madison (Site # 71112)
Madison, Wisconsin, 53726
Hannah Ranous, 608-262-1295, jmranous@clinicaltrials.wisc.edu
- Recruiting
NYU Langone Health (Site # 71177)
New York, New York, 10016
Kate Dzurilla, 347-802-5853, Kathryn.Dzurilla@nyulangone.org
- Recruiting
Mayo Clinic Arizona (Site # 71144)
Phoenix, Arizona, 85054
Debbie Ryan, 480-342-1208, ryan.debra29@mayo.edu
- Recruiting
Washington University (Site # 71157)
St Louis, Missouri, 63110
Gwendolyn Amurao, 314-362-4109, amurao@wustl.edu
About this study
Official title: Targeting the B Cell Response to Treat Antibody-Mediated Rejection With Carfilzomib and Belatacept (CarBel)
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.
Read the detailed description
This is a prospective, multicenter, open-label study evaluating the safety of carfilzomib and belatacept in kidney transplant recipients with donor-specific antibody-associated graft injury. Twenty-five participants will receive steroid pulse/taper, carfilzomib, belatacept, tacrolimus, mycophenolate, and prednisone according to protocol-defined dosing and maintenance immunosuppression. Participants will be followed for 12 months after initiation of investigational therapy, with protocol biopsies performed at 3 months and 12 months after start of investigational therapy. Participants who discontinue study treatment without withdrawing informed consent will continue follow-up to end of study.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Carfilzomib, Belatacept
- Keywords
- Carfilzomib, Kidney transplant, Belatacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibBiological
Also called Kyprolis
Administered by intravenous infusion over 60 minutes.
BelataceptBiological
Also called Nulojix
Administered by intravenous infusion over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Treatment Arm | Experimental | Study Entry to Month-3 participants will receive:
* Steroid pulse/taper
* Kyprolis® (Carfilzomib)
* Nulojix® (Belatacept)
* Tacrolimus
* Mycophenolate
* Prednisone
After 3 months participants will receive:
* Belatacept +
* Mycophenolate
* Prednisone
* Tacrolimus Receives: Biological: Carfilzomib; Biological: Belatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-months post randomization and 12-months post receipt of Investigational Therapy (IT)
Secondary outcomes (15)
Change in albuminuria
Measured: 3-months post randomization and 12-months post receipt of IT
Change in Banff lesion grading score (2022 criteria)
Measured: 3-months post randomization and 12-months post receipt of IT
Change in donor-specific antibody (DSA) MFI
Measured: 3-months post randomization and 12-months post receipt of IT
Change in estimated Glomerular Filtration Rate (eGFR) (2022 criteria)
Measured: 3-months post randomization and 12-months post receipt of IT
Incidence of Antibody-Mediated Rejection (ABMR)
Measured: 3-months post randomization and 12-months post receipt of IT
Incidence of Acute Cellular Rejection (ACR)
Measured: 3-months post randomization and 12-months post receipt of IT
Incidence of mixed ABMR/ACR
Measured: 3-months post randomization and 12-months post receipt of IT
Change in iBox scores
Measured: 3-months post randomization and 12-months post receipt of IT
Number of days hospitalized for administration of protocol
Measured: From entry to week 52
Number of days hospitalized for any other reason
Measured: From entry to week 52
Incidence of bacterial, viral, and fungal infections
Measured: From entry to week 52
Incidence of de novo malignancy
Measured: From entry to week 52
Time to all cause composite allograft loss
Allograft loss is defined as return to dialysis (continually for at least 30 days), allograft nephrectomy, re-transplantation, or death.
Measured: 3-months post randomization and 12-months post receipt of IT
Time to all cause composite death-censored allograft loss
Death-censored allograft loss is defined as return to dialysis (continually for at least 30 days), allograft nephrectomy, or re-transplantation.
Measured: 3-months post randomization and 12-months post receipt of IT
Time to patient death
Measured: 3-months post randomization and 12-months post receipt of IT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start27 May 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stuart J Knechtle, M.D., Principal investigator, Duke University Medical Center: TransplantationScott Sanoff, MD, Ph.D., Study chair, Duke University Medical Center: Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918990
- Sponsor's protocol ID
- DAIT CTOT-42
- Acronym
- CarBel
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No