{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T01:44:54Z","timestamp":1773798294236,"version":"3.50.1"},"reference-count":38,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T00:00:00Z","timestamp":1720742400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Cluster of differentiation 38 (CD38) is a key target on multiple myeloma (MM) cells. This multi\u2010centre, Phase 1, single\u2010agent study (NCT04000282) investigated SAR442085, a novel fragment crystallisable (Fc)\u2010modified anti\u2010CD38 monoclonal antibody (mAb), with enhanced affinity towards Fc\u2010gamma receptor on effector cells in patients with relapsed and\/or refractory (RR) MM.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This study comprised two parts: Part\u2010A (dose\u2010escalation involving anti\u2010CD38 mAb pre\u2010treated and na\u00efve patients) and Part\u2010B (dose expansion). Primary endpoints were maximum tolerated dose and recommended Phase 2 dose (RP2D).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty\u2010seven heavily pre\u2010treated patients were treated in Part A. Part\u2010B (dose\u2010expansion) was not studied. Seven dose\u2010limiting toxicities were reported at DL3, DL5, DL6, and DL7. RP2D was determined to be 5\u20137\u00b75\u2009mg\/kg. Most common treatment\u2010emergent adverse events were infusion\u2010related reactions in 70\u00b73% (26\/37) patients. Grade\u2009\u22653 thrombocytopenia was reported in 48\u00b76% (18\/37). Overall response rate was 70% in anti\u2010CD38 mAb na\u00efve and 4% in anti\u2010CD38 pre\u2010treated patients, with a median progression\u2010free survival of 7\u00b762 (95%CI: 2\u00b7858; not calculable) months and 2\u00b779 (95%CI: 1\u00b7150; 4\u00b7172) months and, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The efficacy of SAR442085 was promising in anti\u2010CD38 mAb na\u00efve patients but did not extend to the larger cohort of anti\u2010CD38 mAb pre\u2010treated patients. This observation, along with transient high\u2010grade thrombocytopenia, could potentially limit its clinical use.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ejh.14270","type":"journal-article","created":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T08:07:17Z","timestamp":1720771637000},"page":"593-605","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["An open\u2010label, first\u2010in\u2010human, single agent, dose escalation study for the evaluation of safety and efficacy of <scp>SAR442085<\/scp> in patients with relapsed or refractory multiple myeloma"],"prefix":"10.1111","volume":"113","author":[{"given":"Prashant","family":"Kapoor","sequence":"first","affiliation":[{"name":"Division of Hematology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nitya","family":"Nathwani","sequence":"additional","affiliation":[{"name":"Judy and Bernard Briskin Center for 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