eligibility_summary
Eligible: 18–65 on hemodialysis, UNOS-listed ≥1 yr, highly sensitized (cPRA ≥99.5–99.9 per OPTN/UNet), consented, stay near site 28 d, contraception, EBV IgG+, TB neg/treated, adequate counts. Exclude: catheter access, prior non-kidney transplant/BMT, BMI ≥35, high UTI risk, HIV, serious infection or viremia, recent biologics/immunosupp, major autoimmune, liver/cardiac/pulmonary disease, pregnancy. Lymphodepletion: flu/COVID test, delay if positive. CAR T only if clinically stable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: CART-BCMA (autologous CAR T targeting B-cell maturation antigen, biological, gene-modified T-cell therapy) and huCART19 (autologous humanized anti-CD19 CAR T, biological). Preconditioning chemotherapy: cyclophosphamide (alkylating agent) ± fludarabine (purine analog antimetabolite) for lymphodepletion to enhance CAR T expansion/persistence. Mechanisms: CAR T cells selectively eliminate BCMA+ antibody-secreting plasma cells and CD19+ B-lineage cells (naive, memory, plasmablasts), reducing anti-HLA antibody production. Targets/pathways: CD19+ B cells, BCMA+ long-lived plasma cells, germinal center and humoral alloimmunity pathways. Goal: desensitization by lowering cPRA to permit kidney transplantation.