{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T05:55:54Z","timestamp":1776318954184,"version":"3.50.1"},"reference-count":34,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T00:00:00Z","timestamp":1776297600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>B001 is a recombinant humanized anti-CD20 monoclonal antibody targeting CD20+ B cells, that has demonstrated superior B cell depletion and anti-proliferative and cytotoxic effects compared to rituximab in a pre-clinical study. The present phase 1b trial assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of B001 in aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (NMOSD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This phase 1b randomized, double-blind, placebo-controlled trial screened 25 NMOSD patients (April 2022\u2013June 2024). Twenty-two patients received intravenous B001 (350, 700 or 1,000 mg) or placebo via a 3\u00a0+\u00a03 dose escalation design, randomized 3:1 to active drug or placebo on days 1 and 15. The primary endpoints were the occurrence of dose-limiting toxicity (DLT) and to recommend the dosage for the phase 2 trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 22 randomized patients (350 mg:\n                      <jats:italic>n<\/jats:italic>\n                      =\u00a03; 700 mg:\n                      <jats:italic>n<\/jats:italic>\n                      =\u00a08; 1,000 mg:\n                      <jats:italic>n<\/jats:italic>\n                      =\u00a06; placebo:\n                      <jats:italic>n<\/jats:italic>\n                      =\u00a05), 20 (90.9%) completed the study. No DLT occurred in evaluable patients. Treatment-related adverse events (TRAEs) occurred in 7\/21 (33.3%) patients, including urinary tract infection (14.3%), infusion-related reactions (9.5%), abnormal blood routine tests (9.5%) and hyperlipidemia (4.8%). No TRAEs led to discontinuation, dose reduction or death. Pharmacokinetic analysis revealed that supra-proportional exposure increased at 1,000 mg\n                      <jats:italic>vs<\/jats:italic>\n                      . 700 mg. Pharmacodynamics showed sustained B cell depletion (nearly 0\/\u03bcL) for 24 weeks. No NMOSD relapses occurred during the 24-week study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>B001 demonstrated favorable safety and tolerability, with 700 mg selected as the recommended phase 2 dose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>https:\/\/clinicaltrials.gov\/study\/NCT05145361<\/jats:ext-link>\n                      , identifier NCT05145361.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fimmu.2026.1676908","type":"journal-article","created":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T05:25:53Z","timestamp":1776317153000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["A novel recombinant anti-cluster of differentiation 20 humanized monoclonal antibody (B001) for the treatment of neuromyelitis optica spectrum disorder: a phase 1, multicenter randomized, double-blind trial"],"prefix":"10.3389","volume":"17","author":[{"given":"Dongmei","family":"Jia","sequence":"first","affiliation":[{"name":"Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital","place":["Tianjin, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huabing","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurology, Beijing Tiantan Hospital, Capital Medical University","place":["Beijing, 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