Actively Recruiting
CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants
Led by Tongji Hospital · Updated on 2026-04-16
12
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability, and efficacy of AZD0120 in highly sensitized adult participants with ESKD awaiting kidney transplant-who, as assessed by investigators, are improbable desensitization through conventional treatments (e.g., plasmapheresis and immunoadsorption)- with or without living donors.
CONDITIONS
Official Title
CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men or women aged 18 to 65 years with end-stage kidney disease waiting for kidney transplant and needing desensitization
- For Cohort 1: A living donor identified per local guidelines
- Highly sensitized status confirmed by positive flow cytometry crossmatch or positive virtual crossmatch (MFI 63 2000) within 30 days of screening
- For Cohort 2: PRA 63 80% and at least one anti-HLA antibody unacceptable for transplant
- High-resolution HLA typing for recipient and donor within 2 years
- Eligible for transplantation locally if graft becomes available after treatment
- Hemoglobin 63 8 g/dL
- Absolute neutrophil count 63 800/bcL
- Absolute lymphocyte count 63 2000/bcL or CD3 T cell count 63 500/bcL
- Platelet count 63 75000/bcL
- Up-to-date vaccinations per transplant center guidance
- Positive for EBV capsid IgG
- Negative latent tuberculosis infection test within 3 months or completed appropriate LTBI therapy
- Willing to be hospitalized at least 2 weeks after infusion and reside within 2 hours of hospital for 2 more weeks
- Capable of giving informed consent
- Contraceptive use consistent with local regulations
- Male participants sexually active with female partners of childbearing potential must use effective birth control for 3 years post infusion and refrain from fathering children or donating sperm
- Female participants of childbearing potential sexually active with non-sterilized males must use effective birth control for 3 years post infusion, have negative pregnancy test before enrollment, and refrain from donating ova for 3 years post infusion
You will not qualify if you...
- Previous solid organ (except kidney) or bone marrow transplant
- Specific kidney diseases causing ESKD: complement 3 glomerulopathy, immune-complex membranoproliferative glomerulonephritis, or focal and segmental glomerulosclerosis
- Severe peripheral arterial disease with resting pain or non-healing skin ulcers
- History of recurrent urinary tract infections (2 in 6 months or 3 in 1 year)
- Active invasive bacterial, viral, or fungal infection or recent infections requiring hospitalization or antibiotics within specified timeframes
- History of HIV infection
- Active hepatitis B or C infection, with some exceptions if viral tests are negative and no cirrhosis
- Detectable viral load for CMV, EBV, BKV, or SARS-CoV-2
- CMV serology incompatible with donor
- History of cirrhosis or severe liver disease with abnormal liver tests
- History of sickle cell disease or systemic amyloidosis
- Chronic illness requiring continuous anticoagulation or antiplatelet therapy, except clinically stable conditions
- Active severe disease needing prolonged immunosuppressive therapy, except low dose glucocorticoids
- Ongoing immunosuppressive treatment within 90 days prior to screening
- Calcineurin inhibitor use within 14 days prior to screening
- B cell depleting or monoclonal antibody therapy within 6 months before enrollment
- Cardiac conditions including advanced heart failure, unstable angina, low ejection fraction, recent myocardial infarction, or implanted cardiac devices
- Moderate to severe lung function impairment with low oxygen saturation or reduced lung volumes
- Known severe allergies or intolerance to AZD0120 or its ingredients including DMSO
- Pregnant, breastfeeding, or planning pregnancy during study or within 3 years after treatment
- Planning to father a child during study or within 3 years after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical Collage of Huazhong University of Science & Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
G
Gang Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here