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We conducted a phase 1 clinical trial of BMS-986354, an autologous BCMA CAR T manufactured using an optimized NEX-T\u00ae process, in participants with triple-class exposed, RRMM. The 65 participants had a median of 5 (range 3\u201313) prior regimens, 39% had cytogenetic high-risk, 91% triple-class refractory, and 43% extra-medullar disease. Part A (dose-escalation) of the study enrolled participants in cohorts receiving 20 (<jats:italic>N<\/jats:italic>\u2009=\u20097), 40 (<jats:italic>N<\/jats:italic>\u2009=\u200924), or 80 (<jats:italic>N<\/jats:italic>\u2009=\u200911)x\u200910<jats:sup>6<\/jats:sup> CAR\u2009+\u2009T-cells. In part B (expansion), an additional 23 participants were treated at the recommended phase 2 dose, 40 \u00d710<jats:sup>6<\/jats:sup> CAR\u2009+\u2009T cells. Across dose levels, cytokine release syndrome (CRS) occurred in 82% (2% grade \u22653), neurotoxicity in 8% (2% grade \u22653), and infections in 32% of participants (5% grade \u2265\u20093). The response rate was 95%, with 46% achieving complete responses. Median progression-free survival was 12.3 months (95% CI 11.3\u201316). Compared to orvacabtagene autoleucel (same CAR construct, conventional manufacturing), BMS-986354 had higher proportion of T central memory cells, were less differentiated and had enhanced potency and proliferative capacity, supporting the use of NEX-T\u00ae in future CAR T development.<\/jats:p>","DOI":"10.1038\/s41375-025-02518-5","type":"journal-article","created":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T13:09:32Z","timestamp":1738760972000},"page":"816-826","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Phase 1 clinical trial of B-Cell Maturation Antigen (BCMA) NEX-T\u00ae Chimeric Antigen Receptor (CAR) T cell therapy CC-98633\/BMS-986354 in participants with triple-class exposed multiple myeloma"],"prefix":"10.1038","volume":"39","author":[{"given":"Gayathri","family":"Ravi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shambavi","family":"Richard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5392-9284","authenticated-orcid":false,"given":"Shaji","family":"Kumar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4547-7534","authenticated-orcid":false,"given":"Shebli","family":"Atrash","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michaela","family":"Liedtke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2510-6536","authenticated-orcid":false,"given":"Gurbakhash","family":"Kaur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4070-1819","authenticated-orcid":false,"given":"Benjamin","family":"Derman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1523-7388","authenticated-orcid":false,"given":"P. Leif","family":"Bergsagel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2815-9561","authenticated-orcid":false,"given":"Sham","family":"Mailankody","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"McCarthy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alok","family":"Shrestha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa M.","family":"Kelly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Ly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharmila","family":"Das","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerill","family":"Thorpe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-5588-4175","authenticated-orcid":false,"given":"Alison","family":"Maier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Divya","family":"Varun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garnet","family":"Navarro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael R.","family":"Burgess","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristen","family":"Hege","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley K.","family":"Koegel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5362-2469","authenticated-orcid":false,"given":"Luciano J.","family":"Costa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,2,5]]},"reference":[{"key":"2518_CR1","doi-asserted-by":"crossref","first-page":"985","DOI":"10.1038\/s41375-020-0734-z","volume":"34","author":"N Shah","year":"2020","unstructured":"Shah N, Chari A, Scott E, Mezzi K, Usmani SZ. B-cell maturation antigen (BCMA) in multiple myeloma: rationale for targeting and current therapeutic approaches. Leukemia. 2020;34:985\u20131005.","journal-title":"Leukemia"},{"key":"2518_CR2","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1056\/NEJMoa2203478","volume":"387","author":"P Moreau","year":"2022","unstructured":"Moreau P, Garfall AL, van de Donk N, Nahi H, San-Miguel JF, Oriol A, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387:495\u2013505.","journal-title":"N Engl J Med"},{"key":"2518_CR3","doi-asserted-by":"crossref","first-page":"2259","DOI":"10.1038\/s41591-023-02528-9","volume":"29","author":"AM Lesokhin","year":"2023","unstructured":"Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. 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S.R. reports honoraria received from Janssen and Bristol Myers Squibb; steering committee participation for Gracell Therapeutics and Bristol Myers Squibb; research support from Janssen, Bristol Myers Squibb, C4 Therapeutics, Gracell Therapeutics, and Heidelberg Pharma; and advisory board participation for Genentech, Janssen, and Bristol Myers Squibb. S.K. reports consulting with no personal payment from AbbVie, Amgen, ArcellX, Beigene, Bristol Myers Squibb, Carsgen, GSK, Janssen, K36, Moderna, Pfizer, Regeneron, Roche-Genentech, Sanofi, and Takeda; consulting with personal payments from CVS Caremark and BD Biosciences; and clinical trial support to institution from AbbVie, Amgen, Astra Zeneca, Bristol Myers Squibb, Carsgen, GSK, Gracell Bio, Janssen, Oricell, Roche-Genentech, Sanofi, Takeda, and Telogenomics. S.A. reports research grants from Karyopharm, GSK, and Amgen; and honoraria from Johnson and Johnson and Sanofi. M.L. reports research support to institution from Bristol Myers Squibb, Alexion, Allogene, Abbvie, Janssen, Biomea, and Seagen; participation on advisory board for Abbvie, Bristol Myers Squibb, Janssen, and Nexcella; and medical writing support from Alexion. G.K. reports participation on advisory board for Pfizer, Bristol Myers Squibb, Sanofi, Jansen, Arcellx, Kite, and Cellectar; and research funding from Bristol Myers Squibb, Janssen, and Arcellx. B.D. reports research funding from Amgen and GSK; consulting fees from Sanofi, Janssen, Canopy, and COTA; and independent reviewer of clinical trial for Bristol Myers Squibb. P.L.F reports grants or contracts from Pfizer; royalties or licenses from Opna Bio and Pfizer; and consulting fees from CellCentric, Salarius Pharmaceuticals, AbbVie, and Omeros Corporation. S.M. reports consulting fees from Evicore, Optum, BioAscend, Janssen Oncology, Bristol Myers Squibb, AbbVie, ECor1, Galapagos, and Legend Biotech; institution research funding from the NCI, Janssen Oncology, Bristol Myers Squibb, Allogene Therapeutics, Fate Therapeutics, Caribou Therapeutics,and Takeda Oncology; and honoraria from OncLive, Physician Education Resource, MJH Life Sciences, and Plexus Communications. P.M. received honoraria from Beigene, Bristol Myers Squibb, Fate Therapeutics, Glaxo-Smith Klein, Hikma Pharmaceuticals, HSC Acquistion, Janssen, Karyopharm Therapeutics, Oncopeptides, Partner Therapeutics, Starton Therapeutics and has served on a data monitoring committee for Bristol Myers Squibb and Karyopharm Therapeutics. A.S., L.M.K, D.V., A.M., G.N. report employment at wholly-owned subsidiaries of Bristol Myers Squibb Company and stock from Bristol Myers Squibb. K.H. reports stock from Bristol Myer Squibb. S.D. reports employment at wholly-owned subsidiaries of Bristol Myers Squibb Company, funding of study, medical writing support, travel support, and stock from Bristol Myers Squibb. J.T. reports employment at wholly-owned subsidiaries of Bristol Myers Squibb Company, stock, and travel support from Bristol Myers Squibb. M.R.B reports employment at wholly-owned subsidiaries of Bristol Myers Squibb Company, travel support, patents, and stock from Bristol Myers Squibb. A.K. reports employment at wholly-owned subsidiaries of Bristol Myers Squibb Company, stock, and patents from Bristol Myers Squibb. L.J.C, received research funding from AbbVie, Amgen, Janssen, wholly-owned subsidiaries of Bristol Myers Squibb, Genentech, honoraria from Amgen, Janssen, wholly-owned subsidiaries of Bristol Myers Squibb, Adaptive Biotechnologies, Sanofi, Pfizer.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}