鲁昔单抗(Lumiliximab) - 药物靶点：CD23_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-CD23 monoclonal antibody、Gomiliximab、Gomiliximab (USAN)

+ [5]

靶点

CD23

作用机制

CD23拮抗剂(免疫球蛋白ε-Fc受体拮抗剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [3]

在研适应症-

非在研适应症

过敏性哮喘哮喘慢性淋巴细胞白血病+ [2]

原研机构

Biogen, Inc.

在研机构-

非在研机构

Biogen Idec Ltd.

Biogen, Inc.Biogen (Denmark) A/S

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 616719387H

来源: *****

Sequence Code 174989L

来源: *****

关联

14

项与鲁昔单抗相关的临床试验

EUCTR2006-002987-24-CZ / Not yet recruitingN/A

A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia - Lumiliximab in combination with FCR in the treatment of relapsed CLL

开始日期2008-08-21

申办/合作机构

Biogen Idec Ltd.

EUCTR2006-002987-24-PT / Not yet recruitingN/A

A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia - Lumiliximab in combination with FCR in the treatment of relapsed CLL

开始日期2008-08-08

申办/合作机构

Biogen Idec Ltd.

EUCTR2006-002987-24-LT / Not yet recruitingN/A

A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia - Lumiliximab in combination with FCR in the treatment of relapsed CLL

开始日期2008-07-04

申办/合作机构

Biogen Idec Ltd.

100 项与鲁昔单抗相关的临床结果

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100 项与鲁昔单抗相关的转化医学

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100 项与鲁昔单抗相关的专利（医药）

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41

项与鲁昔单抗相关的文献（医药）

2024-02-01·Journal of Allergy and Clinical Immunology

IgE directly affects eosinophil migration in chronic rhinosinusitis with nasal polyps through CCR3 and predicts the efficacy of omalizumab

Article

作者: Sun, Ying ; Zhang, Luo ; Cao, Feifei ; Piao, Yingshi ; Yu, Jiaqi ; Shen, Shen ; Li, Ying ; Xiong, Wei ; Wang, Chengshuo ; Wang, Yang ; Hu, Chen ; Yan, Bing

BACKGROUNDWhether IgE affects eosinophil migration in chronic rhinosinusitis with nasal polyps (CRSwNP) remains largely unclear. Moreover, our understanding of local IgE, eosinophils, and omalizumab efficacy in CRSwNP remains limited.OBJECTIVEWe investigated whether IgE acts directly on eosinophils and determined its role in omalizumab therapy.METHODSEosinophils and their surface receptors were detected by hematoxylin and eosin staining and flow cytometry. IgE and its receptors, eosinophil peroxidase (EPX), eosinophilic cationic protein, and CCR3 were detected by immunohistochemistry and immunofluorescence. Functional analyses were performed on blood eosinophils and polyp tissues. Logistic regression was performed to screen for risk factors. Receiver operating characteristic curve was generated to evaluate the accuracy.RESULTSBoth FcεRI and CD23 were expressed on eosinophils. The expression of FcεRI and CD23 on eosinophil in nasal polyp tissue was higher than in peripheral blood (both P < .001). IgE and EPX colocalized in CRSwNP. IgE directly promoted eosinophil migration by upregulating CCR3 in CRSwNP but not in healthy controls. Omalizumab and lumiliximab were found to be effective in restraining this migration, indicating CD23 was involved in IgE-induced eosinophil migration. Both IgE⁺ and EPX⁺ cells were significantly reduced after omalizumab treatment in those who experienced response (IgE⁺ cells, P = .001; EPX⁺ cells, P = .016) but not in those with no response (IgE⁺ cells, P = .060; EPX⁺ cells, P = .151). Baseline IgE⁺ cell levels were higher in those with response compared to those without response (P = .024). The baseline local IgE⁺ cell count predicted omalizumab efficacy with an accuracy of 0.811.CONCLUSIONSIgE directly promotes eosinophil migration, and baseline local IgE⁺ cell counts are predictive of omalizumab efficacy in CRSwNP.

2014-11-01·British Journal of Haematology2区 · 医学

A randomized, open‐label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

2区 · 医学

Article

作者: Flinn, Ian W. ; Byrd, John C. ; N/A ; Hughes, Steven G. ; Robak, Tadeusz ; Trone, Denise ; Hellmann, Andrzej ; Shannon, Megan ; Hillmen, Peter ; Awan, Farrukh T.

SummaryLumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B‐cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open‐label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty‐seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression‐free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.

2012-01-01·Cancer Control4区 · 医学

Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia

4区 · 医学

ReviewOA

作者: Pinilla-Ibarz, Javier ; Veliz, Marays

Background Recent advances in the treatment of chronic lymphocytic leukemia (CLL) have moved beyond the traditional use of alkylating agents and purine analogs into regimens combining these two chemotherapy classes with monoclonal antibodies. Methods This article reviews treatments options for patients with relapsed or refractory CLL. Results Several studies have investigated novel agents in treating patients with 17p deletion, TP53 mutation, and fludarabine-refractory CLL, as well as patients with suboptimal response to intense treatment. These investigational agents include rituximab, alemtuzumab, ofatumumab, bendamustine, high-dose methylprednisolone, lenalidomide, lumiliximab, cyclin-dependent kinase inhibitors, small modular immunopharmaceuticals, Bcl-2 inhibitors, and histone deacetylase inhibitors. While these newer drugs and combination therapies have shown promise as treatment options for CLL, additional studies are needed to determine the immunosuppression, toxicities, and infections associated with their use. Conclusions Despite improvement in initial overall response rates, most patients relapse and require further treatment. CLL remains incurable with standard therapies due to development of disease refractoriness. As such, novel approaches such as those noted above warrant continued research to improve outcomes for patients with CLL.

100 项与鲁昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06463	鲁昔单抗	-	DB06162

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性慢性淋巴细胞白血病	临床3期	澳大利亚	Biogen, Inc.	2006-11-01
过敏性哮喘	临床3期	美国	Biogen Idec Ltd.	-
哮喘	临床3期	-	Biogen (Denmark) A/S	-
慢性淋巴细胞白血病	临床3期	-	Biogen (Denmark) A/S	-
慢性淋巴细胞白血病	临床3期	美国	Biogen Idec Ltd.	-
慢性淋巴细胞白血病	临床3期	加拿大	Biogen Idec Ltd.	-
慢性淋巴细胞白血病	临床3期	澳大利亚	Biogen Idec Ltd.	-
慢性淋巴细胞白血病	临床3期	欧盟	Biogen Idec Ltd.	-
过敏性鼻炎	临床3期	美国	Biogen Idec Ltd.	-
过敏性鼻炎	临床3期	-	Biogen (Denmark) A/S	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00391066 (152CL201, Pubmed \| Int J Radiat Oncol Biol Phys)	临床2/3期	复发性慢性淋巴细胞白血病	627	Lumiliximab with fludarabine, cyclophosphamideLumiliximab with fludarabine, cyclophosphamideLumiliximab with fludarabine, cyclophosphamide and rituximab	(鏇衊淵鑰觸憲窪觸襯艱) = 構艱簾積廠餘夢壓膚鏇鹽夢餘築襯壓醖鹽鬱網 (製廠築選構繭艱鹽壓製 ) 更多	不佳	2014-11-01
	临床2/3期	复发性慢性淋巴细胞白血病	627	Fludarabine, cyclophosphamideFludarabine, cyclophosphamide and rituximab	(鏇衊淵鑰觸憲窪觸襯艱) = 築構壓鬱顧選壓憲簾遞鹽夢餘築襯壓醖鹽鬱網 (製廠築選構繭艱鹽壓製 ) 更多	不佳	2014-11-01
ASCO2008	临床1/2期	复发性慢性淋巴细胞白血病	-	Lumiliximab	(鬱襯簾齋遞製壓醖製願) = 觸襯衊顧鹽壓醖積夢憲製夢膚鬱蓋積鏇簾艱鑰 (觸積構襯網壓衊範顧鏇 ) 更多	-	2008-05-20