Vijay Bhoj, Mary Kaminski, Huiwu Zhao, Kyle Jackson, Wei Wang, C Y Liu, Robert A. Montgomery, Nicole Ali, Massimo Mangiola, Thomas R. Spitzer, Kassem Safa, Vikram Pattanayak, Raeda Taj, Joy Chiu, Thanh-Mai Bui, Elizabeth M. Sonnenberg, James F. Markmann, Michael C. Milone, Carl H. June, Don L. Siegel, Joseph A. Fraietta, Vanessa Gonzalez, Michela Locci, Matthew Palmer, Dimitri Monos, Wei-Ting Hwang, Tina Sledge, Nancy D. Bridges, Julia Goldstein, Jonah Odim, Stuart C. Sweet, Behdad Besharatian, SUFIYA HUSSAIN, N M Brown, Malek Kamoun, Alfred L. Garfall, Ali Naji
HLA sensitization poses a major challenge to kidney transplantation for patients with end-stage kidney disease, especially for highly sensitized candidates. Attempts at antibody elimination (desensitization) have had inconsistent efficacy and have often failed to produce sustained reductions in anti-HLA antibodies in patients with the highest level of sensitization (calculated panel-reactive antibody score, ≥99.9%). We now report the results for the safety run-in cohort of a multicenter phase 1 clinical study evaluating the safety and efficacy of combined CD19-targeted and B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T cells in eliminating the cellular sources of preformed anti-HLA antibodies (ClinicalTrials.gov number, NCT06056102). Kidney transplantation was performed in two highly sensitized candidates after desensitization with the use of dual CAR T-cell therapy.