{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T06:30:47Z","timestamp":1792218647507,"version":"4.4.0"},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"5","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2022,2,10]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> Mosunetuzumab is a bispecific antibody targeting CD20 and CD3 that redirects T cells to engage and eliminate malignant B cells and is being developed for relapsed or refractory (R\/R) B-cell non-Hodgkin lymphomas (B-NHLs). <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> This first-in-human trial (ClinicalTrials.gov identifier: NCT02500407 ) evaluated the safety and tolerability and efficacy of mosunetuzumab in patients with R\/R B-NHL and established the recommended phase II dose. Data from dose escalation are presented. Single-agent mosunetuzumab was administered intravenously in 3-week cycles, at full dose in cycle 1 day 1 (group A) or with ascending (step-up) doses during cycle 1 on days 1, 8, and 15 (group B), for eight or 17 cycles on the basis of tumor response. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> Two hundred thirty patients were enrolled. Doses up to 2.8 mg and 60 mg were assessed in groups A and B, respectively; maximum tolerated dose was not exceeded. In group B (n = 197), common adverse events (\u2265 20% of patients) were neutropenia (28.4%), cytokine release syndrome (27.4%), hypophosphatemia (23.4%), fatigue (22.8%), and diarrhea (21.8%). Cytokine release syndrome was mostly low-grade (grade \u2265 3: 1.0%) and mainly confined to cycle 1. Across the doses investigated (group B), best overall response rates were 34.9% and 66.2% in patients with aggressive and indolent B-NHL, respectively, and complete response rates were 19.4% and 48.5%. Among patients with a complete response, the median duration of response was 22.8 months (95% CI, 7.6 to not estimable) and 20.4 (95% CI, 16 to not estimable) in patients with aggressive and indolent B-NHL, respectively. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> Mosunetuzumab, administered with step-up dosing, has a manageable safety profile and induces durable complete responses in R\/R B-NHL. The expansion stage of the study is ongoing at the dose level of 1\/2\/60\/60\/30 mg selected for further study. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.21.00931","type":"journal-article","created":{"date-parts":[[2021,12,16]],"date-time":"2021-12-16T20:59:44Z","timestamp":1639688384000},"page":"481-491","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":317,"title":["Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study"],"prefix":"10.1200","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1464-5494","authenticated-orcid":false,"given":"Lihua E.","family":"Budde","sequence":"first","affiliation":[{"name":"City of Hope National Medical Center, Duarte, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7638-1589","authenticated-orcid":false,"given":"Sarit","family":"Assouline","sequence":"additional","affiliation":[{"name":"Jewish General Hospital and McGill University, Montreal, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1860-9765","authenticated-orcid":false,"given":"Laurie H.","family":"Sehn","sequence":"additional","affiliation":[{"name":"BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, British Columbia, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen J.","family":"Schuster","sequence":"additional","affiliation":[{"name":"Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sung-Soo","family":"Yoon","sequence":"additional","affiliation":[{"name":"Seoul National University Hospital, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8289-3548","authenticated-orcid":false,"given":"Dok Hyun","family":"Yoon","sequence":"additional","affiliation":[{"name":"Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4581-3721","authenticated-orcid":false,"given":"Matthew J.","family":"Matasar","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9241-2886","authenticated-orcid":false,"given":"Francesc","family":"Bosch","sequence":"additional","affiliation":[{"name":"University Hospital Vall d'Hebron and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5400-0466","authenticated-orcid":false,"given":"Won Seog","family":"Kim","sequence":"additional","affiliation":[{"name":"Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Loretta J.","family":"Nastoupil","sequence":"additional","affiliation":[{"name":"MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6724-290X","authenticated-orcid":false,"given":"Ian W.","family":"Flinn","sequence":"additional","affiliation":[{"name":"Sarah Cannon Research Institute\/Tennessee Oncology, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mazyar","family":"Shadman","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Research Center, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1116-3246","authenticated-orcid":false,"given":"Catherine","family":"Diefenbach","sequence":"additional","affiliation":[{"name":"Perlmutter Cancer Center at NYU Langone Health, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"O'Hear","sequence":"additional","affiliation":[{"name":"Genentech, Inc, South San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3976-4115","authenticated-orcid":false,"given":"Huang","family":"Huang","sequence":"additional","affiliation":[{"name":"F. 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