{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T03:06:17Z","timestamp":1792724777713,"version":"4.5.0"},"reference-count":35,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2021,2,17]],"date-time":"2021-02-17T00:00:00Z","timestamp":1613520000000},"content-version":"unspecified","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2021,1,17]]},"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>T-cell acute lymphoblastic leukemia (T-ALL) is an aggressive disease with a poor cure rate for relapsed\/resistant patients. Due to the lack of T-cell restricted targetable antigens, effective immune-therapeutics are not presently available and the treatment of chemo-refractory T-ALL is still an unmet clinical need. To develop novel immune-therapy for T-ALL, we generated an afucosylated monoclonal antibody (mAb) (ahuUMG1) and two different bispecific T-cell engagers (BTCEs) against UMG1, a unique CD43-epitope highly and selectively expressed by T-ALL cells from pediatric and adult patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>UMG1 expression was assessed by immunohistochemistry (IHC) on a wide panel of normal tissue microarrays (TMAs), and by flow cytometry on healthy peripheral blood\/bone marrow-derived cells, on 10 different T-ALL cell lines, and on 110 T-ALL primary patient-derived cells. CD43-UMG1 binding site was defined through a peptide microarray scanning. ahuUMG1 was generated by Genetic Glyco-Engineering technology from a novel humanized mAb directed against UMG1 (huUMG1). BTCEs were generated as IgG1-(scFv)<jats:sub>2<\/jats:sub> constructs with bivalent (2+2) or monovalent (2+1) CD3\u03b5 arms. Antibody dependent cellular cytotoxicity (ADCC), antibody dependent cellular phagocytosis (ADCP) and redirected T-cell cytotoxicity assays were analysed by flow cytometry. In vivo antitumor activity of ahUMG1 and UMG1-BTCEs was investigated in NSG mice against subcutaneous and orthotopic xenografts of human T-ALL.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among 110 T-ALL patient-derived samples, 53 (48.1%) stained positive (24% of TI\/TII, 82% of TIII and 42.8% of TIV). Importantly, no expression of UMG1-epitope was found in normal tissues\/cells, excluding cortical thymocytes and a minority (&lt;5%) of peripheral blood T lymphocytes. ahUMG1 induced strong ADCC and ADCP on T-ALL cells in vitro, which translated in antitumor activity in vivo and significantly extended survival of treated mice. Both UMG1-BTCEs demonstrated highly effective killing activity against T-ALL cells in vitro. We demonstrated that this effect was specifically exerted by engaged activated T cells. Moreover, UMG1-BTCEs effectively antagonized tumor growth at concentrations &gt;2 log lower as compared with ahuUMG1, with significant mice survival advantage in different T-ALL models in vivo.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Altogether our findings, including the safe UMG1-epitope expression profile, provide a framework for the clinical development of these innovative immune-therapeutics for this still orphan disease.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2020-002026","type":"journal-article","created":{"date-parts":[[2021,2,17]],"date-time":"2021-02-17T19:05:02Z","timestamp":1613588702000},"page":"e002026","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":20,"title":["Therapeutic afucosylated monoclonal antibody and bispecific T-cell engagers for T-cell acute lymphoblastic leukemia"],"prefix":"10.1136","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7870-7565","authenticated-orcid":false,"given":"Daniele","family":"Caracciolo","sequence":"first","affiliation":[{"name":"Department of Experimental and Clinical Medicine, Magna Gr\u00e6cia University of Catanzaro, Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caterina","family":"Riillo","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, Magna Gr\u00e6cia University of Catanzaro, Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Ballerini","sequence":"additional","affiliation":[{"name":"BiovelocITA srl, Milano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Gaipa","sequence":"additional","affiliation":[{"name":"Centro Ricerca M. Tettamanti, Clinica Pediatrica Universit\u00e0 Milano-Bicocca, Ospedale San Gerardo, Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludovic","family":"Lhermitte","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Paris, Institut Necker-Enfants Malades, Institut National de Recherche M\u00e9dicale U1151, Paris, France"},{"name":"Laboratory of Onco-Hematology, Assistance Publique-H\u00f4pitaux de Paris, H\u00f4pital Necker Enfants-Malades, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Rossi","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, Magna Gr\u00e6cia University of Catanzaro, Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cirino","family":"Botta","sequence":"additional","affiliation":[{"name":"Hematology Unit, Annunziata Hospital, Cosenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eug\u00e9nie","family":"Duroyon","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Paris, Institut Necker-Enfants Malades, Institut National de Recherche M\u00e9dicale U1151, Paris, France"},{"name":"Laboratory of Onco-Hematology, Assistance Publique-H\u00f4pitaux de Paris, H\u00f4pital Necker Enfants-Malades, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katia","family":"Grillone","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, Magna Gr\u00e6cia University of Catanzaro, Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Eugenia","family":"Gallo Cantafio","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, Magna Gr\u00e6cia University of Catanzaro, Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Buracchi","sequence":"additional","affiliation":[{"name":"Centro Ricerca M. 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