New Therapies for Highly Sensitized Patients on the Waiting List.
Ashley Vo, Noriko Ammerman, Stanley C Jordan
https://pubmed.ncbi.nlm.nih.gov/38995690Actively Recruiting
Phase 1
Age: 18Years - 65Years
All Genders
ID06056102
Autologous Chimeric Antigen Receptor Engineered T Cell Immunotherapy for Desensitization in Patients Awaiting Kidney Transplantation
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-22
20
Participants Needed
3
Research Sites
730 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 focuses on adults aged 18 to 65 who have been waiting at least one year for a kidney transplant and have a very high calculated panel reactive antibody (cPRA) level of 99.5% or higher. These patients have immune systems that would reject most available kidneys. The study aims to evaluate the safety and feasibility of using a new immunotherapy involving Chimeric Antigen Receptor T Cells (CAR T Cells) combined with chemotherapy to reduce cPRA levels and improve transplant chances. Participants undergo a process starting with leukapheresis to collect T cells, followed by lymphodepleting chemotherapy and infusion of two types of CAR T cells called CART-BCMA and huCART-19. The study includes a safety run-in phase and three treatment cohorts to assess the best tolerated doses. Different drug doses and CAR T cell amounts are given depending on the cohort, with chemotherapy drugs cyclophosphamide and fludarabine used in specific phases. During the main study, which lasts up to two years, participants will attend up to 30 clinic or hospital visits over one year, plus additional visits if a transplant occurs. Researchers will monitor safety by tracking adverse events for 12 months after infusion and measuring changes in cPRA levels for up to one year. Long-term follow-up is planned for 15 years after CAR T cell therapy. Outcomes include the timing, frequency, and severity of side effects, as well as transplant rejection episodes and infections in participants who receive a kidney transplant.
CONDITIONS
Brief Title
CAR-T Cell Therapy for Desensitization in Kidney Transplantation
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18-65 years with kidney failure requiring hemodialysis
- Protocol-specific cPRA of 99.5% or higher
- No suitable living donor or active in kidney paired donation program without match within 12 months
- Blood group Type O or B with predictive positive virtual crossmatch to deceased donor
- Listed with United Network for Organ Sharing (UNOS) for kidney transplant for at least 1 year
- Able to give written informed consent
- Willing to stay within 2 hours of 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 per guidance including TdAP
- Positive for EBV capsid IgG
- Negative testing for latent tuberculosis infection within 3 months or completed therapy
- Hemoglobin ≥9g/dL
- Absolute neutrophil count ≥1,800/µL (or >1,200/µL for Duffy-null associated neutrophil count)
- Absolute lymphocyte count ≥500/µL or CD3 T cell count ≥150/µL
- Platelet count ≥120,000/µL
You will not qualify if you...
- Indwelling catheters as primary hemodialysis access
- 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 or non-tuberculous mycobacterial infections
- History of HIV, chronic hepatitis B or C
- Negative CMV serology
- Detectable viral load for HBV, HCV, CMV, EBV, or BK virus
- B cell depleting or monoclonal antibody therapy within 6 months
- Ongoing immunosuppression including corticosteroids >5mg/day and other specified agents
- Active or severe autoimmune diseases requiring immunosuppression except stable low-dose prednisone for lupus or renal-limited autoimmune conditions
- Chronic illness requiring uninterrupted anticoagulation or antiplatelet therapy
- Severe liver disease or abnormal liver tests exceeding three times normal
- History of sickle cell disease or systemic amyloidosis
- Significant cardiac conditions or recent cardiac events
- Moderate to severe lung function impairment
- Live vaccine within 30 days before leukapheresis
- Treatment with investigational agents within 4 weeks
- Pregnant, breastfeeding, or planning pregnancy during study
- Other medical or social problems posing risk or interfering with study participation per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - Up to several weeks until completion of safety run-in treatment
Participants undergo leukapheresis to collect T cells for CAR T cell manufacturing, followed by lymphodepleting chemotherapy and infusion of CAR T cells as part of a safety run-in phase.
Several visits including leukapheresis, chemotherapy administration, and cell infusion
Treatment
Duration - Several days for chemotherapy and cell infusions
Participants receive lymphodepleting chemotherapy followed by infusion of CART-BCMA and huCART-19 CAR T cells according to their assigned cohort.
Multiple visits for chemotherapy and CAR T cell infusions
Follow-up
Duration - Up to 12 months
Participants are monitored for safety, efficacy, and adverse events for up to 12 months after CAR T cell infusion.
Regular follow-up visits over 12 months
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
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Research Team
M
Mary Kaminski, PA
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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