{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T04:01:00Z","timestamp":1792036860238,"version":"4.4.0"},"reference-count":25,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"31","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2022,11,1]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>ABBV-383, a B-cell maturation antigen \u00d7 CD3 T-cell engaging bispecific antibody, has demonstrated promising results in an ongoing first-in-human phase I study (ClinicalTrials.gov identifier: NCT03933735 ) in patients with relapsed\/refractory multiple myeloma (RRMM). Herein, we report safety and efficacy outcomes of this phase I dose escalation\/expansion study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>Patients with RRMM (\u2265 three prior lines including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody) were eligible. ABBV-383 was administered intravenously over 1-2 hours once every 3 weeks, without any step dosing. A 3 + 3 design with backfilling for dose escalation was used (intrapatient escalation to highest safe dose permitted) followed by initiation of dose expansion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>As of January 8, 2022, 124 patients (dose escalation [0.025-120 mg], n = 73; dose expansion [60 mg], n = 51) have received ABBV-383; median age was 68 years (range, 35-92 years). The most common hematologic treatment-emergent adverse events (TEAEs) were neutropenia (all grades: 37%) and anemia (29%). The most common nonhematologic TEAEs were cytokine release syndrome (57%) and fatigue (30%). Seven deaths from TEAEs were reported with all considered unrelated to study drug by the investigator. For all efficacy-evaluable patients (n = 122; all doses), the objective response rate (ORR) was 57% and very good partial response (VGPR) or better (\u2265 VGPR) rate was 43%. In the 60 mg dose expansion cohort (n = 49), the ORR and \u2265 VGPR rates were 59% and 39%, respectively; and in the \u2265 40 mg dose escalation plus dose expansion cohorts (n = 79) were 68% and 54%, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>ABBV-383 in patients with RRMM was well tolerated with an ORR of 68% at doses \u2265 40 mg. This novel therapy's promising preliminary antitumor activity in heavily pretreated patients warrants further clinical evaluation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.22.01504","type":"journal-article","created":{"date-parts":[[2022,8,27]],"date-time":"2022-08-27T17:25:16Z","timestamp":1661621116000},"page":"3576-3586","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":131,"title":["A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen \u00d7 CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed\/Refractory Multiple Myeloma"],"prefix":"10.1200","volume":"40","clinical-trial-number":[{"clinical-trial-number":"nct03933735","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1092-5643","authenticated-orcid":false,"given":"Anita","family":"D'Souza","sequence":"first","affiliation":[{"name":"Division of Hematology\/Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Shah","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, University of California, San Francisco, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cesar","family":"Rodriguez","sequence":"additional","affiliation":[{"name":"Medical Oncology and Hematology, Wake Forest University School of Medicine, Winston-Salem, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1661-718X","authenticated-orcid":false,"given":"Peter M.","family":"Voorhees","sequence":"additional","affiliation":[{"name":"Plasma Cell Disorders Division, Department of Hematologic Oncology & Blood Disorders, Levine Cancer Institute, Atrium Health\/Wake Forest Baptist, Charlotte, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katja","family":"Weisel","sequence":"additional","affiliation":[{"name":"Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orlando F.","family":"Bueno","sequence":"additional","affiliation":[{"name":"AbbVie, Inc, North Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajvineeth K.","family":"Pothacamury","sequence":"additional","affiliation":[{"name":"AbbVie, Inc, North Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin J.","family":"Freise","sequence":"additional","affiliation":[{"name":"AbbVie, Inc, North Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Yue","sequence":"additional","affiliation":[{"name":"AbbVie, Inc, North Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremy A.","family":"Ross","sequence":"additional","affiliation":[{"name":"AbbVie, Inc, North Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5938-6062","authenticated-orcid":false,"given":"Akshanth R.","family":"Polepally","sequence":"additional","affiliation":[{"name":"AbbVie, Inc, North Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chetasi","family":"Talati","sequence":"additional","affiliation":[{"name":"AbbVie, Inc, North Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shane","family":"Lee","sequence":"additional","affiliation":[{"name":"AbbVie, Inc, North Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ziyi","family":"Jin","sequence":"additional","affiliation":[{"name":"AbbVie, Inc, North Chicago, 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in patients (pts) with relapsed\/refractory multiple myeloma (RRMM). EHA, 2020 (abstr S205)","DOI":"10.1182\/blood-2019-122895"},{"key":"b27","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2203478"},{"key":"b28","doi-asserted-by":"crossref","volume-title":"Early, Deep, and Durable Responses, and Low Rates of Cytokine Release Syndrome with REGN5458, a BCMAxCD3 Bispecific Monoclonal Antibody, in a Phase 1\/2 First-in-Human Study in Patients with Relapsed\/Refractory Multiple Myeloma (RRMM)","author":"Zonder JA","DOI":"10.1182\/blood-2021-144921"},{"key":"b29","first-page":"921","volume-title":"Blood","volume":"126","author":"Rajkumar SV","year":"2015"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.22.01504","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,10,27]],"date-time":"2022-10-27T18:00:49Z","timestamp":1666893649000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.22.01504"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,1]]},"references-count":25,"journal-issue":{"issue":"31","published-print":{"date-parts":[[2022,11,1]]}},"alternative-id":["10.1200\/JCO.22.01504"],"URL":"https:\/\/doi.org\/10.1200\/jco.22.01504","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,11,1]]},"assertion":[{"value":"2022-06-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-21","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-28","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-08-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}