{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T17:12:24Z","timestamp":1766509944513,"version":"3.48.0"},"reference-count":16,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T00:00:00Z","timestamp":1764201600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000646","name":"Japan Society for the Promotion of Science London","doi-asserted-by":"publisher","award":["24K11563"],"award-info":[{"award-number":["24K11563"]}],"id":[{"id":"10.13039\/501100000646","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Reports"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Lisocabtagene maraleucel (liso\u2010cel) is a CD19\u2010directed chimeric antigen receptor T\u2010cell therapy for patients with relapsed or refractory large B\u2010cell lymphoma.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this retrospective study involving 22 patients, we evaluated the association between peripheral blood CD4\/CD8 ratios and the occurrence of out\u2010of\u2010specification (OOS) products during manufacturing. Expanded access protocols have permitted the infusion of OOS products, despite their failure to meet commercial release criteria, under close regulatory oversight.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Five patients who received OOS products had significantly lower CD4\/CD8 ratios (median 0.22 vs. 0.46;\n                      <jats:italic>p<\/jats:italic>\n                      =\u20090.008).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Our findings suggest that a low CD4\/CD8 ratio (below one\u2010third) may be a predictive marker for OOS outcomes, potentially supporting patient selection and treatment planning. Therefore, prospective validation using a larger cohort is warranted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cnr2.70413","type":"journal-article","created":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T10:31:04Z","timestamp":1764239464000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Peripheral Blood\n                    <scp>CD4<\/scp>\n                    \/\n                    <scp>CD8<\/scp>\n                    Ratio Predicts Out\u2010of\u2010Specification Products in Lisocabtagene Maraleucel Manufacturing"],"prefix":"10.1002","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0055-4591","authenticated-orcid":false,"given":"Taichi","family":"Hirano","sequence":"first","affiliation":[{"name":"Department of Haematology, Rheumatology, and Infectious Diseases Kumamoto University Hospital  Kumamoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8131-3401","authenticated-orcid":false,"given":"Hiro","family":"Tatetsu","sequence":"additional","affiliation":[{"name":"Department of Haematology, Rheumatology, and Infectious Diseases Kumamoto University Hospital  Kumamoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shikiko","family":"Ueno","sequence":"additional","affiliation":[{"name":"Department of Haematology, Rheumatology, and Infectious Diseases Kumamoto University Hospital  Kumamoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1272-3738","authenticated-orcid":false,"given":"Takafumi","family":"Shichijo","sequence":"additional","affiliation":[{"name":"Department of Haematology, Rheumatology, and Infectious Diseases Kumamoto University Hospital  Kumamoto 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Biosystemic Science Kyushu University Graduate School of Medicine  Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kisato","family":"Nosaka","sequence":"additional","affiliation":[{"name":"Department of Haematology, Rheumatology, and Infectious Diseases Kumamoto University Hospital  Kumamoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0473-754X","authenticated-orcid":false,"given":"Masao","family":"Matsuoka","sequence":"additional","affiliation":[{"name":"Department of Haematology, Rheumatology, and Infectious Diseases Kumamoto University Hospital  Kumamoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7939-2080","authenticated-orcid":false,"given":"Jun\u2010ichirou","family":"Yasunaga","sequence":"additional","affiliation":[{"name":"Department of Haematology, Rheumatology, and Infectious Diseases Kumamoto University Hospital  Kumamoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,27]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1707447"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1804980"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(20)31366\u20100"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2023011992"},{"volume-title":"Biologics License Application 125714 \u2013 Breyanzi (Lisocabtagene Maraleucel)","year":"2021","author":"US 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