{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T01:06:55Z","timestamp":1779930415898,"version":"3.53.1"},"reference-count":15,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T00:00:00Z","timestamp":1779840000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T00:00:00Z","timestamp":1779840000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis & Rheumatology"],"abstract":"\n Objective<\/jats:title>\n To evaluate the safety and preliminary efficacy of HBI0101, B cell maturation antigen targeted chimeric antigen receptor T cell therapy, in patients with severe refractory systemic lupus erythematosus or systemic sclerosis.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We conducted an ongoing phase 1 trial of HBI0101 in six patients with severe systemic lupus erythematosus (n\u00a0=\u00a03) or systemic sclerosis (n\u00a0=\u00a03). The median age was 41 years (range: 21\u201365), the median disease duration was 2.7 years (range: 1.1\u201320.5), and patients had received a median of 3.5 previous lines of immunomodulatory therapy (range: 2\u20139). The median follow\u2010up was six months (range: 6\u20139).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Grade 3 to 4 neutropenia occurred in two patients and was managed with supportive care. Three patients had hypogammaglobulinemia requiring intravenous immunoglobulin replacement. Cytokine release syndrome occurred in five patients (grade 2 in three and grade 1 in two) and was absent in one patient. No immune effector cell\u2010associated neurotoxicity syndrome was observed. In systemic lupus erythematosus, the Systemic Lupus Erythematosus Disease Activity Index 2000 decreased to 0 in two patients and to 4 in one patient. In systemic sclerosis, skin involvement improved in all three patients with reductions in modified Rodnan skin score and European Scleroderma Trials and Research activity indices.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n HBI0101 demonstrated an acceptable safety profile and early clinical activity in patients with severe refractory systemic lupus erythematosus or systemic sclerosis, supporting further prospective evaluation.<\/jats:p>\n \n \n \n image<\/jats:alt-text>\n <\/jats:graphic>\n <\/jats:boxed-text>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/art.70211","type":"journal-article","created":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T03:09:08Z","timestamp":1778209748000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["B cell Maturation Antigen Targeted Chimeric Antigen Receptor T Cell Therapy for Refractory Systemic Lupus Erythematosus and Systemic Sclerosis"],"prefix":"10.1002","author":[{"given":"Shlomit","family":"Kfir\u2010Erenfeld","sequence":"first","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5055-5317","authenticated-orcid":false,"given":"Shlomo","family":"Elias","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Asherie","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hadass Pri","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Hypertension, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Karger","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miri","family":"Assayag","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilie","family":"Bohbot","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rim","family":"Elmikawy","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alaa","family":"Shaheen","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmad","family":"Bazbaz","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tal","family":"Friedman\u2010Korn","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vered","family":"Molho\u2010Pessach","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ada","family":"Vaknin","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigal","family":"Grisariu","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Batia","family":"Avni","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eran","family":"Zimran","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nomi","family":"Zalcman","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alaa","family":"Shehadeh","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aseel","family":"Ishtay","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatyana","family":"Dubnikob","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelly","family":"Regev","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rivka","family":"Alexander\u2010Shani","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam","family":"Schlossberg","sequence":"additional","affiliation":[{"name":"Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine Hebrew University of Jerusalem 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