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This study was designed to assess the safety and preliminary efficacy of a novel anti\u2010B\u2010cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell in R\/R MM and PCL.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Between February 22, 2017, and June 25, 2018, 28 R\/R and two R\/R primary PCL patients received a median dose of 11.2 \u00d7 10<jats:sup>6<\/jats:sup> CAR+ cells\/kg. The subjects were refractory to a proteasome inhibitor and\/or an immunomodulatory agent. Fludarabine and cyclophosphamide were given as lymphodepletion chemotherapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Results for these 30 consecutive patients who received an anti\u2010BCMA CAR T cell infusion are reported. The patients had received a median of four prior lines of therapy. A total of 44 different types of adverse events were recorded, and hematologic toxic effects were the most common events of any grade during treatment. Hematologic toxic effects were also the most common events of grade 3 or higher. A total of 29 patients (96.7%) had cytokine release syndrome, which was of grade 1 or 2 in 24 patients (80%) and grade 3 in five patients (16.7%). Neurologic toxic effects only occurred in one patient (3.3%) and were of grade 1. The objective response rate was 90%, and the complete response rate was 43.3%. With a median follow\u2010up of 12.6 months, the median progression\u2010free survival (PFS) and overall survival were 5.2 months and 14.0 months. One of the two primary PCL achieved a complete response with a PFS of 307 days. The other patients achieved a very good partial response with a PFS of 117 days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Anti\u2010BCMA CAR T cell treatment is safe and highly active in R\/R multiple myeloma.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ctm2.346","type":"journal-article","created":{"date-parts":[[2021,3,10]],"date-time":"2021-03-10T05:45:22Z","timestamp":1615355122000},"source":"Crossref","is-referenced-by-count":65,"title":["A phase I study of anti\u2010BCMA CAR T cell therapy in relapsed\/refractory multiple myeloma and plasma cell leukemia"],"prefix":"10.1002","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5134-7133","authenticated-orcid":false,"given":"Chunrui","family":"Li","sequence":"first","affiliation":[{"name":"Department of Hematology, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology  Wuhan Hubei China"},{"name":"Immunotherapy Research Center for Hematologic Diseases of Hubei Province  Wuhan Hubei China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenyue","family":"Cao","sequence":"additional","affiliation":[{"name":"Department of Hematology, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology  Wuhan Hubei China"},{"name":"Immunotherapy Research Center for Hematologic Diseases of Hubei Province  Wuhan Hubei China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9676-8123","authenticated-orcid":false,"given":"Yimei","family":"Que","sequence":"additional","affiliation":[{"name":"Department of Hematology, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology  Wuhan Hubei China"},{"name":"Immunotherapy Research Center for Hematologic Diseases of Hubei Province  Wuhan Hubei China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiuxiang","family":"Wang","sequence":"additional","affiliation":[{"name":"Wuhan No.1 Hospital  Wuhan Hubei China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Xiao","sequence":"additional","affiliation":[{"name":"Department of Hematology, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology  Wuhan Hubei China"},{"name":"Immunotherapy Research Center for Hematologic Diseases of Hubei Province  Wuhan Hubei China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chaojiang","family":"Gu","sequence":"additional","affiliation":[{"name":"College of Life Science and Health Wuhan University of Science and Technology  Wuhan Hubei China"},{"name":"Wuhan Bio\u2010Raid Biotechnology Co., Ltd.  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