{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T21:09:42Z","timestamp":1786482582641,"version":"build-2736575974"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2023,7,24]],"date-time":"2023-07-24T00:00:00Z","timestamp":1690156800000},"content-version":"vor","delay-in-days":2,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Pharmaceutical Co., Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,10,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>This dose-escalation part of an ongoing Phase I study assessed the tolerability, safety and pharmacokinetics of mosunetuzumab in Japanese patients with relapsed\/refractory B-cell non-Hodgkin lymphoma (NHL).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Mosunetuzumab was administered intravenously, with step-up dosing in a 3\u00a0+\u00a03 design, on Days 1, 8 and 15 of Cycle 1, and Day 1 of each subsequent 21-day\u00a0cycle for up to 17\u00a0cycles to patients across five cohorts with different target doses (2.8, 6.0, 13.5, 27.0 or 60.0\u00a0mg).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>As of 5 July 2022, 23 patients had received mosunetuzumab. The median patient age was 63.0\u00a0years, 56.5% of patients were male, and 69.6% of patients had diffuse large B-cell lymphoma, 17.4% had transformed follicular lymphoma (FL) and 13.0% had FL. The median number of prior lines of therapy was 4. Mosunetuzumab was well tolerated and there were no deaths. The most common adverse events (any grade) were neutropenia\/neutrophil count decreased (47.8%) and cytokine release syndrome (34.8%). Most cytokine release syndrome events were Grade 1\/2 (one Grade 3), and most occurred within 24\u00a0hours of the first dose of mosunetuzumab. The apparent half-life of mosunetuzumab was 4.1\u20135.0\u00a0days. Two patients achieved a complete response, and 11 patients achieved a partial response.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This study demonstrated that mosunetuzumab has an acceptable safety profile and antitumor activity in Japanese patients with relapsed\/refractory B-cell NHL. The recommended Phase II dose of 1.0\/2.0\/60.0\/60.0\/30.0\u00a0mg was tolerable and there were no new or different safety signals compared with the global Phase I study.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyad082","type":"journal-article","created":{"date-parts":[[2023,7,24]],"date-time":"2023-07-24T11:34:57Z","timestamp":1690198497000},"page":"912-921","source":"Crossref","is-referenced-by-count":7,"title":["Dose-escalation part of Phase I study of single-agent mosunetuzumab in Japanese patients with relapsed\/refractory B-cell non-Hodgkin lymphoma"],"prefix":"10.1093","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4679-0656","authenticated-orcid":false,"given":"Wataru","family":"Munakata","sequence":"first","affiliation":[{"name":"Department of Hematology, National Cancer Center Hospital , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9129-8057","authenticated-orcid":false,"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Cancer Center Hospital , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Mishima","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirokazu","family":"Nagai","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Hospital Organization Nagoya Medical Center , Nagoya , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Ishihara","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, The Cancer Institute Hospital, 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