加利昔单抗(Galiximab) - 药物靶点：CD80_在研适应症：B细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-B7.1-MAb、Anti-CD80 monoclonal antibody、Galiximab (USAN/INN)

+ [4]

靶点

CD80

作用机制

CD80抑制剂(分化群80抑制剂)、免疫调节剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Biogen-Idec Pharmaceuticals, Inc.Hospital García IMSS

非在研机构

Biogen, Inc.

Biogen Idec Ltd.

最高研发阶段临床2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 319922122L

来源: *****

Sequence Code 319922121H

来源: *****

关联

7

项与加利昔单抗相关的临床试验

NCT00651443 / Terminated临床1期

A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma

The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.

开始日期2008-08-01

申办/合作机构

Biogen, Inc.

NCT00516217 / Completed临床2期IIT

A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma

RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkin's lymphoma.

开始日期2008-06-01

申办/合作机构

Alliance Foundation Trials LLC

[+1]

EUCTR2006-003987-74-ES / Not yet recruiting临床3期

Estudio de fase III, abierto, multicéntrico y de un solo brazo, del retratamiento con galiximab en combinación con rituximab en sujetos con linfoma no Hodgkin folicular en recidiva que han respondido previamente en el Estudio 114-NH-301A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination with Rituximab for Subjects with Relapsed, Follicular Non-Hodgkin’s Lymphoma who Previously Responded on Study 114-NH-301

开始日期2007-07-01

申办/合作机构

Biogen Idec Ltd.

100 项与加利昔单抗相关的临床结果

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100 项与加利昔单抗相关的转化医学

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100 项与加利昔单抗相关的专利（医药）

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110

项与加利昔单抗相关的文献（医药）

2022-01-01·Leukemia Research Reports

Immunotherapy in indolent Non-Hodgkin's Lymphoma

Article

作者: Bazarbachi, Ali ; El-Cheikh, Jean ; Amhaz, Ghid

Treatment of non-Hodgkin lymphoma (NHL) in general has improved over the years with the emergence of the monoclonal antibodies (MAB) therapy. NHL is divided into B cell NHL and T cell NHL. Treatment of NHL was based on the subtype of NHL and its staging. NHL is divided into aggressive and indolent NHL (iNHL). Subtypes of iNHL include: Follicular lymphoma (FL), Marginal zone lymphoma (MZL), Chronic lymphocytic leukemia/small-cell lymphocytic lymphoma (CLL/SLL), Gastric mucosa-associated lymphoid tissue (MALT) lymphoma, Lymphoplasmacytic lymphoma, Waldenström macroglobulinemia, Nodal marginal zone lymphoma (NMZL), Splenic marginal zone lymphoma (SMZL). Chemotherapy was the main stay treatment of iNHL until the emergence of Rituximab, anti-CD20 MAB targeting CD-20 surface cell antigens that are present on B-cells lymphoma and not on precursor cells, mainly efficacious in B cell iNHL, It became the mainstay treatment in follicular lymphoma (FL) as a single agent modality or in combination with chemotherapy. The anti-CD20 Rituximab played an important role in the development of the treatment of iNHL to become FDA approved in 1997. It was also proven effective in multiple other types of lymphoma. MAB through targeting the cell surface antigen leads to a direct or immune mediated cytotoxicity. This carries few side effects, including allergic reactions. Other than that, a resistance mechanism to rituximab emerged by inducing a failure in the apoptosis mechanism. Alternative mechanisms of resistance included the presence of soluble antigens that could act by binding to the antibody present before the drug itself can bind the lymphoma cell. Thus, the interest in immunotherapy grew further to explore the possibility of conjugating an immune mediated drug to a radio-sensitizing agent in order to enhance the selectivity of the drug. Here came the development of 90Y-ibritumomab tiuxetan and 131I-tositumomab. After it, humanized anti-CD20 emerged ofatumumab, IMMU106 (veltuzumab) in 2005, and ocrelizumab which are considered as second generation anti-CD20 and 3^rd generation anti-CD20 include AME-133v (ocaratuzumab), PRO131921 and GA101 (obinutuzumab). Also multiple other agents emerged targeting different surface cell antigens like CD52 (alemtuzumab), CD22 (unconjugated epratuzumab and calicheamicin conjugated CMC-544 [inotuzumab ozogamicin]), CD80 (galiximab), CD2 (MEDI-507 [siplizumab]), CD30 (SGN-30 and MDX-060 [iratumumab], Brentuximab vedotin), CD40 (SGN-40), and CD79b (Polatuzumab). Other agents include MAB targeting T-Cells like mogamulizumab, Denileukin Diftitox and BiTEs or bispecific T cell engagers like Mosunetuzumab, Glofitamab, and Epcoritamab. Moreover, further studies came up to evaluate the role of immunotherapy in combination chemotherapy as a pathway to evade the resistance mechanisms. Side effects of the treatment were mainly infusion related adverse reactions, myelosuppression in conjugated forms leading to immunosuppression and subsequently to infectious complications. Another important aspect in immunotherapy is the half-lives of the medication which is an important factor that can influence the evaluation of the response. The MAB treatment showed important benefit in the treatment of iNHL and it continuously shows how rapidly it can develop to provide optimum care and benefit to patients with iNHL.

2021-01-06·BioMed Research International3区 · 生物学

CD80 Insights as Therapeutic Target in the Current and Future Treatment Options of Frequent-Relapse Minimal Change Disease

3区 · 生物学

ReviewOA

作者: Mualif, Siti Aisyah ; Jusoh, Norhana ; Teh, Yoong Mond ; Osman, Kahar ; Lim, Soo Kun

Minimal change disease (MCD) is the most common cause of idiopathic nephrotic syndrome in children, and it is well known for its multifactorial causes which are the manifestation of the disease. Proteinuria is an early consequence of podocyte injury and a typical sign of kidney disease. Steroid-sensitive patients react well with glucocorticoids, but there is a high chance of multiple relapses. CD80, also known as B7-1, is generally expressed on antigen-presenting cells (APCs) in steroid-sensitive MCD patients. Various glomerular disease models associated with proteinuria demonstrated that the detection of CD80 with the increase of urinary CD80 was strongly associated closely with frequent-relapse MCD patients. The role of CD80 in MCD became controversial because one contradicts finding. This review covers the treatment alternatives for MCD with the insight of CD80 as a potential therapeutic target. The promising effectiveness of CD20 (rituximab) antibody and CD80 inhibitor (abatacept) encourages further investigation of CD80 as a therapeutic target in frequent-relapse MCD patients. Therapeutic-based antibody towards CD80 (galiximab) had never been investigated in MCD or any kidney-related disease; hence, the role of CD80 is still undetermined. A new therapeutic approach towards MCD is essential to provide broader effective treatment options besides the general immunosuppressive agents with gruesome adverse effects.

2020-11-01·Transplantation2区 · 医学

A Clinical Trial With Adoptive Transfer of Ex Vivo-induced, Donor-specific Immune-regulatory Cells in Kidney Transplantation—A Second Report

2区 · 医学

Article

作者: Bashuda, Hisashi ; Nakajima, Ichiro ; Teraoka, Satoshi ; Seino, Ken-Ichiro ; Uchida, Koichiro ; Fuchinoue, Shohei ; Koyama, Ichiro ; Okumura, Ko ; Habu, Sonoko

Background.Although the outcome of kidney transplantation (KTx) has improved, various adverse effects of immunosuppressants and chronic rejection aggravate the long-term prognosis of patients. Therefore, the induction of immune tolerance may be an effective therapeutic strategy.Methods.A clinical trial aiming at immune tolerance induction was conducted in kidney transplant recipients from HLA mismatched living donors by infusing autologous donor-specific regulatory T cells (Treg). To obtain Treg, recipient’s peripheral blood mononuclear cells were cocultured with irradiated donor cells in the presence of anti-CD80/CD86 monoclonal antibody for 2 weeks. For preconditioning, splenectomy + cyclophosphamide (CP) was employed in the first series (group A; n = 9). In group B, splenectomy was substituted by preadministration of rituximab (group B; n = 3). In the latest cases, rituximab + rabbit antithymocyte globulin was administered instead of cyclophosphamide (group C; n = 4). Twelve days after KTx, the cultured cells were intravenously infused, and immunosuppressants were gradually tapered thereafter.Results.Although mixed lymphocyte reaction was remarkably suppressed in a donor-specific fashion, 6 out of 9 patients from group A, 1 out of 3 from group B, and 1 out of 4 from group C developed acute rejection within 1 year after KTx. Complete cessation of immunosuppression was not achieved, and a small dose of immunosuppressants was continued.Conclusions.The adoptive transfer of autologous ex vivo-expanded Treg is 1 of the options to possibly induce alloimmune hyporesponsiveness. However, in the present study, further regimen optimization is still required and should be the focus of future investigations.

1

项与加利昔单抗相关的新闻（医药）

2005-06-14

·BioSpace

The Day In Review: Biotech Ends With A Gain

June 14, 2005 In another session marked by low volatility, stocks closed generally higher, though Nasdaq did not get out of negative territory until the closing bell. The Centient Biotech 200 added on 5 points to end at 3335.27, a rise of .16%. The S&P 500 was up .26% and Nasdaq was, for all practical purposes, flat. Mylan announced a stock buy-back plan and a huge upward revision to earnings guidance, Edwards will revise its revolutionary heart valve replacement surgery, Amylin impressed observers with its recently approved insulin-like drug, Dynavax presented strong data for its hepatitis B vaccine, Trimeris signed a deal with ChemBridge to develop HIV medications, Biogen Idec says that Rituxan, together with galiximab, extended event-free survival for non-Hodgkins lymphoma, Santarus said Zegrid did a better job of suppressing gastric acid than blockbuster Protonix, and rumors circulated around SciClone, once again. More details...

疫苗

100 项与加利昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04295	加利昔单抗	-	DB04901

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
B细胞淋巴瘤	临床2期	墨西哥	Hospital García IMSS	2012-04-15
B细胞淋巴瘤	临床2期	美国	Biogen-Idec Pharmaceuticals, Inc.	2012-04-15
非霍奇金淋巴瘤	临床2期	-	Biogen, Inc.	2006-09-01
难治性滤泡性淋巴瘤	临床2期	美国	Biogen, Inc.	2002-01-01
银屑病	临床2期	美国	Biogen Idec Ltd.	-

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临床结果

适应症

分期

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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


NCT00516217 (CTgov)	临床2期	难治性霍奇金淋巴瘤	30	galiximab	繭遞選選鹹鬱鏇艱願顧(顧築願構鹹憲窪憲鏇廠) = 鹹鹽膚範壓鏇憲鏇憲鑰遞窪衊築衊憲醖鑰衊窪 (廠蓋願鹹顧獵窪醖構觸, 窪艱衊觸範構鹹淵選願 ~ 簾繭衊繭鹹壓醖願鹽構) 更多	-	2015-02-04
CALGB 50602 (ASCO2010)	临床2期	复发性霍奇金淋巴瘤	30	Galiximab	(鏇鏇範膚餘襯鏇蓋糧窪) = 艱蓋膚範壓鹹製鏇鑰選獵積選淵窪襯繭網蓋艱 (夢鹹鹽醖廠築簾憲鑰積, 0.9 ~ 22.8) 更多	不佳	2010-05-20