Early Phase Study of AZD0120 CAR-T Therapy Targeting CD19 and BCMA for Desensitization in Highly Sensitized Adults With End-Stage Kidney Disease Awaiting Transplant

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 therapys effects and safety over time.

CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants