重组人源化抗CD52单克隆抗体 (兰州生物制品研究所)(Recombinant anti-CD52 humanized monoclonal antibody(Lanzhou Institute of Biological Products Co. Ltd.)) - 药物靶点：CD52_在研适应症：B细胞幼淋巴细胞白血病，慢性淋巴细胞白血病，弥漫性大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-

靶点

CD52

作用机制

CD52抑制剂(CAMPATH-1抗原抑制剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [1]

在研适应症

B细胞幼淋巴细胞白血病慢性淋巴细胞白血病弥漫性大B细胞淋巴瘤+ [5]

非在研适应症-

原研机构

兰州生物制品研究所有限责任公司

在研机构

上海泰因生物工程有限公司

兰州生物制品研究所有限责任公司

非在研机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)临床1期

特殊审评-

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关联

2

项与重组人源化抗CD52单克隆抗体 (兰州生物制品研究所) 相关的临床试验

NCT05557903 / Unknown status临床1期

Recombinant Humanized Anti-CD52 Monoclonal Antibody in the Treatment of Relapsed and Refractory NHL and Initially Treated T-PLL Phase I Clinical Study on Safety and Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy

Phase I clinical study of multicenter, single-arm, open, non-randomized evaluation of recombinant humanized anti-CD52 monoclonal antibody in the NHL and T-PLL

开始日期2021-12-20

申办/合作机构

兰州生物制品研究所有限责任公司

CTR20202120 / Recruiting临床1期

多中心、单臂、开放、非随机化评价重组人源化抗CD52 单克隆抗体注射液治疗复发难治的 NHL（包括CLL/SLL、 PLL、 PTCL、弥漫大 B 细胞淋巴瘤、滤泡细胞淋巴瘤、套细胞淋巴瘤、边缘区淋巴瘤）、初治的 T-PLL 安全及耐受性、药代动力学特征并初步探索疗效的Ⅰ期临床研究。

主要研究目的是评价单次、多次不同剂量重组人源化抗 CD52 单克隆抗体注射液在患者体内的安全性及耐受性，并确定剂量限制性毒性（DLT）和最大耐受剂量（MTD），为Ⅱ期推荐剂量（RP2D）。次要研究目的是评价单次、多次不同剂量重组人源化抗 CD52 单克隆抗体注射液在患者体内的药代动力学（PK）特征并初步探索疗效。

开始日期2020-11-25

申办/合作机构

上海泰因生物工程有限公司

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100 项与重组人源化抗CD52单克隆抗体 (兰州生物制品研究所) 相关的临床结果

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100 项与重组人源化抗CD52单克隆抗体 (兰州生物制品研究所) 相关的转化医学

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100 项与重组人源化抗CD52单克隆抗体 (兰州生物制品研究所) 相关的专利（医药）

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39

项与重组人源化抗CD52单克隆抗体 (兰州生物制品研究所) 相关的文献（医药）

2016-11-08·Oncotarget

Low pH impairs complement-dependent cytotoxicity against IgG-coated target cells

Article

作者: Varese, Augusto ; Dantas, Ezequiel ; Sabatté, Juan ; Ostrowski, Matías ; Merlotti, Antonela ; Díaz, Fernando Erra ; Gerber, Pehuén Pereyra ; Geffner, Jorge

Local acidosis is a common feature of allergic, vascular, autoimmune, and cancer diseases. However, few studies have addressed the effect of extracellular pH on the immune response. Here, we analyzed whether low pH could modulate complement-dependent cytotoxicity (CDC) against IgG-coated cells. Using human serum as a complement source, we found that extracellular pH values of 5.5 and 6.0 strongly inhibit CDC against either B lymphoblast cell lines coated with the chimeric anti-CD20 mAb rituximab or PBMCs coated with the humanized anti-CD52 mAb alemtuzumab. Suppression of CDC by low pH was observed either in cells suspended in culture medium or in whole blood assays. Interestingly, not only CDC against IgG-coated cells, but also the activation of the complement system induced by the alternative and lectin pathways was prevented by low pH. Tumor-targeting mAbs represent one of the most successful tools for cancer therapy, however, the use of mAb monotherapy has only modest effects on solid tumors. Our present results suggest that severe acidosis, a hallmark of solid tumors, might impair complement-mediated tumor destruction directed by mAb.

2015-11-01·Clinical Journal of the American Society of Nephrology1区 · 医学

Outcomes Associated with Steroid Avoidance and Alemtuzumab among Kidney Transplant Recipients

1区 · 医学

Article

作者: Serrano, Oscar K ; Ahsanuddin, Sayeeda ; Kayler, Liise K ; Ben-Yaacov, Almog ; Friedmann, Patricia ; Millan, Carlos

BACKGROUND AND OBJECTIVESAlemtuzumab is a humanized anti-CD52 monoclonal antibody used as induction in kidney transplantation (KTX) since 2003. Few studies have evaluated long-term outcomes of this agent or changes in outcomes over time.DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTSA retrospective cohort study was performed examining United States registry data from 2003 to 2014 of primary KTX recipients receiving induction with alemtuzumab (AZ; n=5521) or antithymocyte globulin (ATG; n=8504) and maintenance immunosuppression with tacrolimus and mycophenolate mofetil and early withdrawal of steroids. The primary outcome was overall death-censored graft survival (DCGS), and secondary outcomes were overall patient survival and 1-year acute rejection. Multivariate models were fit with donor, recipient, and transplant covariates. Because poorer outcomes with AZ may occur from a learning curve impact with the use of a new medication, transplant year was categorized into three time periods to evaluate outcomes over time (2003-2005, 2006-2008, ≥2009), and an interaction term of induction type with transplant year category was included in all models to test for era impacts.RESULTSOn multivariate analysis of DCGS there was a significant interaction between AZ and era (P<0.001). AZ was significantly associated with inferior DCGS in the earliest 2003-2005 era (adjusted hazard ratio [aHR], 2.21; 95% confidence interval [95% CI], 1.72 to 2.84) but not in the middle 2006-2008 era (aHR, 1.14; 95% CI, 0.96 to 1.36) or the most recent 2009-2014 era (aHR, 1.08; 95% CI, 0.90 to 1.29) compared with ATG. Risk-adjusted patient survival (aHR, 1.32; 95% CI, 1.08 to 1.61; aHR, 1.26; 95% CI, 1.09 to 1.46; and aHR, 1.10; 95% CI, 0.93 to 1.29 by era, respectively) and acute rejection (adjusted odds ratio [aOR], 1.17; 95% CI, 0.96 to 1.42; aOR, 0.94; 95% CI, 0.82 to 1.07; aOR, 0.89; 95% CI, 0.81 to 0.98 by era, respectively) with AZ was comparable with ATG in the most recent era; however, there was no significant interaction with time (P=0.13 and P=0.06, respectively).CONCLUSIONSCurrent alemtuzumab utilization is associated with comparable graft and patient survival and acute rejection compared with ATG. Graft survival with alemtuzumab has improved over time.

2011-09-27·Transplantation2区 · 医学

Single Dose of Alemtuzumab Induction With Steroid-Free Maintenance Immunosuppression in Pancreas Transplantation

2区 · 医学

Article

作者: Hiroko Shike ; Varun Ramprasad ; Riaz Shah ; Akhtar Khan ; Nasrollah Ghahramani ; Umar Farooq ; Osun Kwon ; Kazuhide Matsushima ; Zakiyah Kadry ; Tadahiro Uemura ; Tracy Valania

BACKGROUNDThe use of alemtuzumab (humanized anti-CD52 monoclonal antibody) has been primarily studied in renal transplantation, and the experience of alemtuzumab induction in pancreas transplantation is still limited. The objective of this study is to analyze the outcome of pancreas transplantation by using a single dose of 30 mg alemtuzumab induction with steroid-free maintenance immunosuppression.METHODSWe performed a total 28 pancreas transplants (17 simultaneous kidney-pancreas transplantation [SPK], 5 pancreas after kidney transplantation [PAK], and 6 pancreas transplant alone [PTA]) between November 2006 and April 2010. Median follow-up was 25 months (range, 8-49 months). Maintenance immunosuppression consists of tacrolimus and mycophenolate. We analyzed patient/graft survival, graft function, and complications.RESULTSOne-year actuarial patient/graft survival was 100%/100% in SPK, PAK, and PTA. Three-year actuarial patient/pancreas graft survival rates for SPK, PAK, and PTA were 100%/100%, 100%/100%, and 100%/83%, respectively. Excellent pancreas and kidney graft functions were observed. Acute cellular rejection occurred in 42% of patients. Most of the rejection episode occurred approximately 1 or 6 months after transplant. Absolute lymphocyte count remained below preoperative level for 1 year posttransplant and WBC counts were significantly lower for 3 years after transplant compared with pretransplant level. Cytomegalovirus infection and bacterial infection occurred in 28% and 36% of patients, respectively. Eleven percent of patients developed donor-specific antibodies and 7% of patients experienced antibody-mediated rejection.CONCLUSIONA single dose of 30 mg alemtuzumab induction with steroid-free maintenance immunosuppression achieved excellent mid-term patient and graft survival for pancreas transplantation with acceptable complication rate.

100 项与重组人源化抗CD52单克隆抗体 (兰州生物制品研究所) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
B细胞幼淋巴细胞白血病	临床1期	中国	兰州生物制品研究所有限责任公司	2020-11-25
B细胞幼淋巴细胞白血病	临床1期	中国	上海泰因生物工程有限公司	2020-11-25
套细胞淋巴瘤	临床1期	中国	兰州生物制品研究所有限责任公司	2020-11-25
套细胞淋巴瘤	临床1期	中国	上海泰因生物工程有限公司	2020-11-25
边缘区B细胞淋巴瘤	临床1期	中国	上海泰因生物工程有限公司	2020-11-25
边缘区B细胞淋巴瘤	临床1期	中国	兰州生物制品研究所有限责任公司	2020-11-25
外周T细胞淋巴瘤	临床1期	中国	兰州生物制品研究所有限责任公司	2020-11-25
外周T细胞淋巴瘤	临床1期	中国	上海泰因生物工程有限公司	2020-11-25
小淋巴细胞淋巴瘤	临床1期	中国	上海泰因生物工程有限公司	2020-11-25
小淋巴细胞淋巴瘤	临床1期	中国	兰州生物制品研究所有限责任公司	2020-11-25