Phase 1 Study of CAR T Cell Therapy to Reduce Immune Sensitization in Adults Awaiting Kidney Transplant

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.

CAR-T Cell Therapy for Desensitization in Kidney Transplantation