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ATIR101 is a haploidentical, na\u00efve cell-enriched T-cell product, depleted of recipient-alloreactive T cells to minimize the risk of GvHD and provide graft-versus-infection and -leukemia activity. Safety and efficacy of ATIR101 administered after T-cell-depleted haploidentical HSCT (TCD-haplo\u2009+\u2009ATIR101) without posttransplant immunosuppressors were evaluated in a Phase 2, multicenter study of 23 patients with acute leukemia and compared with an observational cohort undergoing TCD-haplo alone (<jats:italic>n<\/jats:italic>\u2009=\u200935), matched unrelated donor (MUD; <jats:italic>n<\/jats:italic>\u2009=\u200964), mismatched unrelated donor (MMUD; <jats:italic>n<\/jats:italic>\u2009=\u200937), and umbilical cord blood (UCB; <jats:italic>n<\/jats:italic>\u2009=\u200922) HSCT. The primary endpoint, 6-month non-relapse mortality (NRM), was 13% with TCD-haplo\u2009+\u2009ATIR101. One year post\u00a0HSCT, TCD-haplo\u2009+\u2009ATIR101 resulted in lower NRM versus TCD-haplo alone (<jats:italic>P<\/jats:italic>\u2009=\u20090.008). GvHD-free, relapse-free survival (GRFS) was higher with TCD-haplo\u2009+\u2009ATIR101 versus MMUD and UCB (both <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.03; 1-year rates: 56.5%, 27.0%, and 22.7%, respectively) and was not statistically different from MUD (1 year: 40.6%). ATIR101 grafts with high third-party reactivity were associated with fewer clinically relevant viral infections. Results suggest that haploidentical, selective donor-cell depletion may eliminate requirements for posttransplant immunosuppressors without increasing GvHD risk, with similar GRFS to MUD. Following these results, a randomized Phase 3 trial versus posttransplant cyclophosphamide had been initiated.<\/jats:p>","DOI":"10.1038\/s41375-020-0733-0","type":"journal-article","created":{"date-parts":[[2020,2,11]],"date-time":"2020-02-11T14:02:56Z","timestamp":1581429776000},"page":"1907-1923","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["ATIR101 administered after T-cell-depleted haploidentical HSCT reduces NRM and improves overall survival in acute leukemia"],"prefix":"10.1038","volume":"34","author":[{"given":"Denis Claude","family":"Roy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irwin","family":"Walker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"Maertens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Lewalle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo","family":"Olavarria","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominik","family":"Selleslag","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvie","family":"Lachance","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Buyse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kun","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeroen","family":"Rovers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Santi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Halvard","family":"Bonig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Sandler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jurjen","family":"Velthuis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Mielke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,2,11]]},"reference":[{"key":"733_CR1","doi-asserted-by":"crossref","first-page":"1037","DOI":"10.1038\/bmt.2015.6","volume":"50","author":"A Sureda","year":"2015","unstructured":"Sureda A, Bader P, Cesaro S, Dreger P, Duarte RF, Dufour C, et al. 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DS and IW have received research funding from Kiadis Pharma in relation to this study. IS, JV, and AS are employees of Kiadis Pharma and may hold stocks and options. JR is a former employee and holds stocks and options. HB has received research support from: Terumo BCT, Chugai, Polyphor, Sandoz-Hexal (a Novartis Company), Bayer, Uniqure, Erydel, Miltenyi, Stage (a Celgene Company); received honoraria\/speaker\u2019s fees from: Terumo BCT, Fresenius, Miltenyi, Kiadis, Sandoz-Hexal, Chugai; served on advisory boards for: Genzyme, Celgene, Novartis, Terumo BCT, Sandoz-Hexal, Stage; and receives royalties from: Medac. His employer serves as contract manufacturer of ATIR101 (Kiadis). SM reports travel support and speaker\u2019s fees (personal) from Cellex; travel support and expert panel involvement (via his institution) with Gilead; personal fee (consultancy) and travel support from MSD; travel support and speaker\u2019s fees (personal and via his institution) from Celgene; research funding, speaker\u2019s fee, and travel support (via his institution) from Kiadis; speaker\u2019s fee (personal) from Jazz; expert panel involvement with Bellicum (via his institution); travel support, speaker\u2019s fee, and data safety monitoring board involvement (all via his institution) with Miltenyi. IW reports grants from Kiadis during the conduct of the study. MB and KW are employees of IDDI; and MB is a stockholder of IDDI and CluePoints. EO has received support and fees (personal) from Kiadis Pharma. EMW has served on advisory boards from Novartis, Pfizer, MSD; and reports travel support from MEDAC. JM reports personal fees from: Gilead Sciences, Merck, Pfizer, Astellas Pharma, F2G, Cidara, Amplyx; grants from: Gilead Sciences and Pfizer; and non-financial support from: Gilead Sciences, Merck, Astellas Pharma, F2G, Cidara, and Amplyx. SL and PL declare no conflicts.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}