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Transl. Med."],"published-print":{"date-parts":[[2026,8,19]]},"abstract":"<jats:p>\n                    Chimeric antigen receptor (CAR) T cell therapy for acute myeloid leukemia (AML) is constrained by antigen heterogeneity and shared expression with healthy compartments, and there are often challenges in obtaining autologous T cells from heavily pretreated patients. To address these challenges, we developed universal donor-derived, base-edited, anti-CD33 CAR T cells (BE-CAR33) that used precise multiplexed cytidine deamination to simultaneously disrupt the\n                    <jats:italic toggle=\"yes\">TRAC<\/jats:italic>\n                    ,\n                    <jats:italic toggle=\"yes\">CD52<\/jats:italic>\n                    , and\n                    <jats:italic toggle=\"yes\">CD7<\/jats:italic>\n                    loci to prevent graft-versus-host disease and evade immunotherapy effects. An open-label, nonrandomized, single-center phase 1 study (ISRCTN14430213) evaluated the safety, feasibility, and activity of BE-CAR33 cell therapy ahead of allogeneic stem cell transplantation (allo-SCT) for patients with AML. Eligible participants were aged less than 16 years with relapsed\/refractory AML. Five patients were screened, and three were enrolled; one additional adult received BE-CAR33 through compassionate access. Participants received fludarabine, cyclophosphamide, and alemtuzumab followed by 1.2 to 1.8\u00a0\u00d7\u00a010\n                    <jats:sup>6<\/jats:sup>\n                    BE-CAR33 cells per kilogram. Treatment-emergent adverse events included cytokine release syndrome (grade\u00a0\u22642), neurotoxicity (grade 3), cytopenias (grade 4), and transient rashes. Two patients demonstrated reduced minimal residual disease and proceeded to allo-SCT. Serial flow cytometry, chimerism quantification, and vector copy number analyses tracked BE-CAR33 T cells until elimination during transplant. Differentially expressed genes included editing signatures and switched from manufacturing-related toward postexpansion effector and exhaustion profiles. Although primary end points were not met, this first-in-human study demonstrated the feasibility of an \u201coff-the-shelf\u201d base-edited CAR T cell approach and informs future multiantigen strategies against AML.\n                  <\/jats:p>","DOI":"10.1126\/scitranslmed.aei0875","type":"journal-article","created":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T17:59:03Z","timestamp":1787162343000},"update-policy":"https:\/\/doi.org\/10.34133\/aaas_crossmark","source":"Crossref","is-referenced-by-count":2,"title":["A phase 1 feasibility trial of BE-CAR33, an \u201coff-the-shelf\u201d base-edited CAR33 T cell therapy for acute myeloid leukemia"],"prefix":"10.1126","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0031-8396","authenticated-orcid":true,"given":"Christos","family":"Georgiadis","sequence":"first","affiliation":[{"name":"UCL Great Ormond Street Institute of Child Health, London, WC1N 1DZ, 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