Actively Recruiting
An Early-Phase Study of AZD0120, a CAR-T Therapy Targeting CD19 and BCMA, for Desensitization in Highly Sensitized Adults With End Stage Kidney Disease Awaiting Kidney Transplant
Led by Tongji Hospital · Updated on 2026-04-16
12
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD0120, a dual-targeted CD19 and BCMA CAR-T cell therapy, in adults with end-stage kidney disease (ESKD) who are highly sensitized and awaiting kidney transplant. These participants are considered unlikely to respond to standard desensitization treatments like plasmapheresis and immunoadsorption. The study is an early-phase, single-arm, open-label trial that divides participants into two groups: those with living donors and those without. Participants will receive a single intravenous infusion of AZD0120. The study includes two cohorts: Cohort 1 involves participants with identified living donors, and Cohort 2 includes those without living donors but with high panel reactive antibody levels. The therapy aims to reduce sensitization to enable safer kidney transplantation, and participants will be hospitalized for at least two weeks after infusion and stay within two hours of the hospital for monitoring. During the study, participants will be monitored for treatment-related adverse events and dose-limiting toxicities over an average of three years. Researchers will assess various markers such as CAR transgene levels, antibody responses, lymphocyte counts, cytokine levels, immunoglobulin changes, and crossmatch results. Vaccination antibody levels and immune cell profiles will also be evaluated to understand the therapy's effects and safety over time.
CONDITIONS
Brief 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 awaiting kidney transplant and requiring desensitization
- Cohort 1: Identified living donor meeting donation criteria
- Highly sensitized with positive flow cytometry crossmatch and positive virtual crossmatch with anti-HLA antibodies (MFI 5 2000)
- Cohort 2: Panel reactive antibody (PRA) 5 80% with at least one unacceptable anti-HLA antibody
- High-resolution HLA typing for recipient and donor within 2 years
- Eligible for transplantation according to local standards if a graft becomes available
- Hemoglobin 6 8 g/dL
- Absolute neutrophil count (ANC) 6 800/bcL
- Absolute lymphocyte count 6 2000/bcL or CD3 T cell count 6 500/bcL
- Platelet count 6 75000/bcL
- Vaccinations up to date per transplant center guidance
- Positive Epstein-Barr virus capsid IgG
- Negative latent TB infection test within 3 months or completed LTBI therapy
- Willing to be hospitalized for at least 2 weeks after AZD0120 infusion and reside within 2 hours of hospital for 2 additional weeks
- Able to give signed informed consent
- Use contraception consistent with local regulations for 3 years post-infusion (specific requirements for males and females)
- Negative pregnancy test for females of childbearing potential before enrollment
You will not qualify if you...
- Previous solid organ (except kidney) or bone marrow transplant
- Certain kidney diseases causing ESKD: complement 3 glomerulopathy, immune-complex membranoproliferative glomerulonephritis, focal and segmental glomerulosclerosis
- Severe peripheral arterial disease with resting pain or non-healing ulcers
- History of recurrent urinary tract infections (2 in 6 months or 3 in 1 year)
- Active invasive bacterial, viral, or fungal infections or recent serious infections requiring hospitalization or antibiotics
- History of HIV infection
- Active hepatitis B or C infection or detectable viral loads for CMV, EBV, BKV, or SARS-CoV-2
- Incompatible CMV serology with donor
- History of severe liver disease or cirrhosis
- History of sickle cell disease or systemic amyloidosis
- Chronic illness requiring ongoing anticoagulation or antiplatelet therapy unless stable
- Active severe disease requiring prolonged immunosuppressive therapy except low-dose glucocorticoids
- Recent immunosuppressive treatments or certain medications within specified timeframes before screening
- Cardiac conditions including severe heart failure or recent myocardial infarction
- Moderate to severe lung function abnormalities
- Known allergies or intolerances to AZD0120 or excipients including DMSO
- Pregnant, breastfeeding, or planning pregnancy during the study or within 3 years post-infusion
- Planning to father a child during the study or within 3 years post-infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with monitoring through study completion, an average of 3 years
Participants receive a single dose of AZD0120 via intravenous infusion for desensitization.
Hospitalization for at least 2 weeks post-infusion and residence within 2 hours of hospital for 2 additional weeks; follow-up visits over 3 years
Duration - Up to approximately 3 years after treatment
Participants are monitored for safety, efficacy, and immune response through regular assessments after treatment.
Regular follow-up visits over 3 years to assess safety and treatment effects
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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