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Erschienen in: International Journal of Hematology 6/2019

26.03.2019 | Original Article

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

verfasst von: Ken Ohmachi, Michinori Ogura, Youko Suehiro, Kiyoshi Ando, Toshiki Uchida, Ilseung Choi, Yoshiaki Ogawa, Miki Kobayashi, Koichi Fukino, Yuki Yokoi, Jun Okamura

Erschienen in: International Journal of Hematology | Ausgabe 6/2019

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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.
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Metadaten
Titel
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
verfasst von
Ken Ohmachi
Michinori Ogura
Youko Suehiro
Kiyoshi Ando
Toshiki Uchida
Ilseung Choi
Yoshiaki Ogawa
Miki Kobayashi
Koichi Fukino
Yuki Yokoi
Jun Okamura
Publikationsdatum
26.03.2019
Verlag
Springer Japan
Erschienen in
International Journal of Hematology / Ausgabe 6/2019
Print ISSN: 0925-5710
Elektronische ISSN: 1865-3774
DOI
https://doi.org/10.1007/s12185-019-02635-9

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