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国产抗CD20单抗治疗CD20(+)B细胞非霍奇金淋巴瘤的Ⅰ期临床耐受性和药效学研究
OBJECTIVE: To evaluate the tolerance and safety of a human-mouse chimeric anti-CD20 monoclonal antibody IBI301 in Chinese patients achieved objective response with CD20(+) B-cell non-Hodgkin's lymphoma (NHL). METHODS: Nine patients with CD20(+) B-cell NHL received dose-escalating IBI301 infusio...
Formato: | Online Artículo Texto |
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Lenguaje: | English |
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Editorial office of Chinese Journal of Hematology
2018
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342123/ https://www.ncbi.nlm.nih.gov/pubmed/29779330 http://dx.doi.org/10.3760/cma.j.issn.0253-2727.2018.04.013 |
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collection | PubMed |
description | OBJECTIVE: To evaluate the tolerance and safety of a human-mouse chimeric anti-CD20 monoclonal antibody IBI301 in Chinese patients achieved objective response with CD20(+) B-cell non-Hodgkin's lymphoma (NHL). METHODS: Nine patients with CD20(+) B-cell NHL received dose-escalating IBI301 infusions (250 mg/m(2), n=3; 375 mg/m(2), n=3; 500 mg/m(2), n=3, respectively). The data of all patients were collected for safety analyses. The median exposures of 125 mg/m(2), 375 mg/m(2), 500 mg/m(2) dose groups were 243, 690 and 980 mg, respectively. Safety and tolerability were evaluated by monitoring adverse events (AE). The ratios of CD19(+), CD20(+) B cells and the levels IgG and IgM were detected to evaluate the pharmacodynamics. RESULTS: Totally 52 events of AE were observed, including 18 events of AE in 125 mg/m(2) group, 14 events of AE in 375 mg/m(2) group and 20 events of AE in 500 mg/m(2) group, respectively. There were 26 adverse reactions of 52 cases of AE, 22 reactions were judged to be probably related to IBI301, and 4 reactions were not probably related to IBI301, all disappeared or returned to baseline levels. Common AE in this study included decreased WBC, upper respiratory infection, decreased neutrophil count, dyspepsia, hyperuricemia, paresthesia, oral mucositis and dizziness. No patients quitted or trial discontinued. No severe AE (SAE) were reported. No dose-limiting toxicity (DLT) events were observed in the study. The ratio of CD20(+) and CD19(+) B cells decreased in all subjects. There was no significant changes of the levels of IgG and IgM. CONCLUSION: The single dose of IBI301 injection was well tolerated, and the AE occurred in the patients recovered. No SAE were reported, No DLT events were observed in the study. The IBI301 caused an elimination of the peripheral CD20-expressing B cells in all patients. |
format | Online Article Text |
id | pubmed-7342123 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Editorial office of Chinese Journal of Hematology |
record_format | MEDLINE/PubMed |
spelling | pubmed-73421232020-07-16 国产抗CD20单抗治疗CD20(+)B细胞非霍奇金淋巴瘤的Ⅰ期临床耐受性和药效学研究 Zhonghua Xue Ye Xue Za Zhi 论著 OBJECTIVE: To evaluate the tolerance and safety of a human-mouse chimeric anti-CD20 monoclonal antibody IBI301 in Chinese patients achieved objective response with CD20(+) B-cell non-Hodgkin's lymphoma (NHL). METHODS: Nine patients with CD20(+) B-cell NHL received dose-escalating IBI301 infusions (250 mg/m(2), n=3; 375 mg/m(2), n=3; 500 mg/m(2), n=3, respectively). The data of all patients were collected for safety analyses. The median exposures of 125 mg/m(2), 375 mg/m(2), 500 mg/m(2) dose groups were 243, 690 and 980 mg, respectively. Safety and tolerability were evaluated by monitoring adverse events (AE). The ratios of CD19(+), CD20(+) B cells and the levels IgG and IgM were detected to evaluate the pharmacodynamics. RESULTS: Totally 52 events of AE were observed, including 18 events of AE in 125 mg/m(2) group, 14 events of AE in 375 mg/m(2) group and 20 events of AE in 500 mg/m(2) group, respectively. There were 26 adverse reactions of 52 cases of AE, 22 reactions were judged to be probably related to IBI301, and 4 reactions were not probably related to IBI301, all disappeared or returned to baseline levels. Common AE in this study included decreased WBC, upper respiratory infection, decreased neutrophil count, dyspepsia, hyperuricemia, paresthesia, oral mucositis and dizziness. No patients quitted or trial discontinued. No severe AE (SAE) were reported. No dose-limiting toxicity (DLT) events were observed in the study. The ratio of CD20(+) and CD19(+) B cells decreased in all subjects. There was no significant changes of the levels of IgG and IgM. CONCLUSION: The single dose of IBI301 injection was well tolerated, and the AE occurred in the patients recovered. No SAE were reported, No DLT events were observed in the study. The IBI301 caused an elimination of the peripheral CD20-expressing B cells in all patients. Editorial office of Chinese Journal of Hematology 2018-04 /pmc/articles/PMC7342123/ /pubmed/29779330 http://dx.doi.org/10.3760/cma.j.issn.0253-2727.2018.04.013 Text en 2018年版权归中华医学会所有 http://creativecommons.org/licenses/by-nc-sa/3.0/ This work is licensed under a Creative Commons Attribution 3.0 License (CC-BY-NC). The Copyright own by Publisher. Without authorization, shall not reprint, except this publication article, shall not use this publication format design. Unless otherwise stated, all articles published in this journal do not represent the views of the Chinese Medical Association or the editorial board of this journal. |
spellingShingle | 论著 国产抗CD20单抗治疗CD20(+)B细胞非霍奇金淋巴瘤的Ⅰ期临床耐受性和药效学研究 |
title | 国产抗CD20单抗治疗CD20(+)B细胞非霍奇金淋巴瘤的Ⅰ期临床耐受性和药效学研究 |
title_full | 国产抗CD20单抗治疗CD20(+)B细胞非霍奇金淋巴瘤的Ⅰ期临床耐受性和药效学研究 |
title_fullStr | 国产抗CD20单抗治疗CD20(+)B细胞非霍奇金淋巴瘤的Ⅰ期临床耐受性和药效学研究 |
title_full_unstemmed | 国产抗CD20单抗治疗CD20(+)B细胞非霍奇金淋巴瘤的Ⅰ期临床耐受性和药效学研究 |
title_short | 国产抗CD20单抗治疗CD20(+)B细胞非霍奇金淋巴瘤的Ⅰ期临床耐受性和药效学研究 |
title_sort | 国产抗cd20单抗治疗cd20(+)b细胞非霍奇金淋巴瘤的ⅰ期临床耐受性和药效学研究 |
topic | 论著 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342123/ https://www.ncbi.nlm.nih.gov/pubmed/29779330 http://dx.doi.org/10.3760/cma.j.issn.0253-2727.2018.04.013 |
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