{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T11:21:42Z","timestamp":1791976902163,"version":"4.4.0"},"reference-count":18,"publisher":"American Society of Hematology","issue":"5","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,7,31]]},"abstract":"<jats:sec>\n                  <jats:title>Abstract<\/jats:title>\n                  <jats:p>FCARH143, an autologous B-cell maturation antigen (BCMA)\u2013targeted chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, which incorporates a fully human BCMA-specific single chain variable fragment and 4-1BB costimulatory domain, was evaluated in a phase 1 trial for relapsed\/refractory multiple myeloma (RRMM). Patients were stratified by bone marrow plasma cell involvement (10%-30% or &amp;gt;30%) and received lymphodepleting chemotherapy followed by escalating CAR-T doses (50 \u00d7 106 to 450 \u00d7 106). The primary end point was safety; secondary end points were overall response rate (ORR), duration of response, and progression-free survival (PFS). Among 28 enrolled patients, all underwent leukapheresis and successful CAR-T manufacturing, although 3 (11%) did not proceed to infusion. The 25 treated patients (median age, 64 years) had a median of 8 prior therapies, 80% were triple-class refractory, and 44% had extramedullary disease. Cytokine release syndrome occurred in 84% (8% grade 3-4 and no grade 5), and neurotoxicity in 24% (12% grade 3 and no grade 4-5). No treatment-related deaths occurred. At a median follow-up of 67.3 months, treated patients had an ORR of 100%, including a stringent complete response in 64%. Median PFS and overall survival (OS) were 15.5 and 32.1 months, respectively. In an intention-to-treat analysis (median follow-up, 69.6 months), the ORR was 89.3%, and OS was 30.2 months. FCARH143 demonstrated potent antimyeloma activity, with a 100% response rate and manageable toxicity, independent of disease burden or cytogenetic risk. Further evaluation in high-risk RRMM is warranted. This trial was registered at www.clinicaltrials.gov as #NCT03338972.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1182\/blood.2024027681","type":"journal-article","created":{"date-parts":[[2025,4,8]],"date-time":"2025-04-08T16:10:35Z","timestamp":1744128635000},"page":"535-545","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":8,"title":["A phase 1 trial of fully human BCMA CAR-T therapy for relapsed\/refractory multiple myeloma with 5-year follow-up"],"prefix":"10.1182","volume":"146","author":[{"given":"Sherilyn A.","family":"Tuazon","sequence":"first","affiliation":[{"name":"1Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA"},{"name":"2Division of Hematology and Oncology, Department of Medicine, University of Washington, Seattle, WA"},{"name":"3Immunotherapy Integrated Research Center, Fred Hutchinson Cancer Center, Seattle, WA"},{"name":"4Department of Cell Therapy, Juno Therapeutics, a Bristol 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