A multicenter phase I study of inebilizumab, a humanized anti-CD19 monoclonal antibody, in Japanese patients with relapsed or refractory B-cell lymphoma and multiple myeloma.

Abstract	This multicenter, phase I, open-label dose escalation study evaluated safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of inebilizumab in Japanese patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), or multiple myeloma (MM) who were ineligible for hematopoietic stem cell transplantation. Patients received inebilizumab 2, 4, or 8 mg/kg intravenously on days 1 and 8 of the first 28-day cycle, and once every 28 days thereafter, with a 12 mg/kg cohort added. Twenty patients (11 FL, six DLBCL, two CLL, and one MM) received inebilizumab at four dose levels (2 mg/kg cohort, n = 3; 4 mg/kg cohort, n = 7; 8 mg/kg cohort, n = 4; 12 mg/kg cohort, n = 6). Three patients experienced dose-limiting toxicities: grade 4 neutropenia/grade 3 leukopenia (n = 1, 12 mg/kg) and grade 3 infusion reaction (n = 1 each, 4 mg/kg and 12 mg/kg); the maximum tolerated dose was 8 mg/kg. Four (three FL and one DLBCL) patients achieved complete response; eight (six FL and two DLBCL) achieved partial response. Overall response rate was 60%. Over the dose ranges evaluated, the pharmacokinetic profile of inebilizumab in Japanese patients was generally dose proportional. This phase I study showed acceptable toxicity and preliminary and promising efficacy of inebilizumab in patients with relapsed/refractory FL and DLBCL.
Authors	Ken Ohmachi, Michinori Ogura, Youko Suehiro, Kiyoshi Ando, Toshiki Uchida, Ilseung Choi, Yoshiaki Ogawa, Miki Kobayashi, Koichi Fukino, Yuki Yokoi, Jun Okamura
Journal	International journal of hematology (Int J Hematol) Vol. 109 Issue 6 Pg. 657-664 (Jun 2019) ISSN: 1865-3774 [Electronic] Japan
PMID	30915717 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study)
Chemical References	Antibodies, Monoclonal, Humanized Antigens, CD19 CD19 molecule, human inebilizumab
Topics	Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects, pharmacokinetics) Antigens, CD19 (immunology) Asian People Female Humans Infusions, Intravenous Lymphoma, B-Cell (drug therapy) Male Middle Aged Multiple Myeloma (drug therapy) Recurrence Treatment Outcome

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