Actively Recruiting
CAR-T Cell Therapy for Desensitization in Kidney Transplantation
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2025-11-26
20
Participants Needed
3
Research Sites
970 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
U
University of Pennsylvania Clinical Cell and Vaccine Production Facility (CVPF)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA. The main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell. The primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and/or recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.
CONDITIONS
Official Title
CAR-T Cell Therapy for Desensitization in Kidney Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18-65 years with kidney failure requiring hemodialysis
- Listed for kidney transplant with United Network for Organ Sharing (UNOS) for at least 1 year
- Have a protocol-specific cPRA of 99.5% or higher with specific conditions including no matched living donor, blood group Type O or B, and documented positive crossmatch
- Eligible for additional kidney priority based on cPRA 99.5%
- Able to understand and give written informed consent
- Willing to stay within 2 hours of the study site for at least 28 days after last T cell infusion
- Agree to use contraception for at least 1 year after CAR T cell infusion if of reproductive potential
- Up to date vaccinations including TdAP
- Positive for EBV capsid IgG
- Negative or appropriately treated for latent TB infection within 3 months prior to enrollment
- Hemoglobin 9 g/dL
- Absolute neutrophil count 1,800/bcL (or >1,200/bcL for Duffy-null associated neutrophil count)
- Absolute lymphocyte count 500/bcL or CD3 T cell count 150/bcL
- Platelet count 120,000/bcL
You will not qualify if you...
- Indwelling catheters as primary access for hemodialysis
- Previous solid organ (except kidney) or bone marrow transplant
- Body mass index (BMI) 35 kg/m2
- Preserved or oliguric urine output >100 cc/day with recurrent urinary tract infections or structural kidney disease increasing infection risk
- Active or recent invasive fungal infection or non-tuberculous mycobacterial infection
- History of HIV, chronic hepatitis B or C
- Negative CMV serology
- Detectable viral loads for HBV, HCV, CMV, EBV, or BK virus
- B cell depleting or monoclonal antibody therapy within 6 months prior to enrollment
- Ongoing immunosuppression including corticosteroids or other specified drugs within 90 days prior to study
- Active or severe autoimmune diseases requiring prolonged immunosuppressive therapy
- Chronic illness requiring continuous anticoagulation or antiplatelet therapy
- History of severe liver disease or abnormal liver tests
- History of sickle cell disease or systemic amyloidosis
- Cardiac conditions including recent myocardial infarction or severe heart failure
- Moderate to severe lung function abnormalities
- Recent live vaccine within 30 days of leukapheresis
- Treatment with investigational agents within 4 weeks prior to screening
- Pregnant, breastfeeding, or planning pregnancy during study follow-up
- Other social or medical problems posing additional risks or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital: Transplantation (Site #: 71107)
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
NYU Langone Health (Site #: 71177)
New York, New York, United States, 10016
Actively Recruiting
3
University of Pennsylvania Medical Center (Site #: 71111)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Mary Kaminski, PA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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