Ublituximab(Ublituximab) - 药物靶点：CD20_在研适应症：复发性多发性硬化，难治性慢性淋巴细胞白血病，小淋巴细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Rituximab biobetter、Rituximab biobetter - TG Therapeutics、Ublituximab (USAN/INN)

+ [11]

靶点

CD20

作用机制

CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用

治疗领域

免疫系统疾病神经系统疾病其他疾病+ [2]

在研适应症

复发性多发性硬化难治性慢性淋巴细胞白血病小淋巴细胞淋巴瘤+ [1]

非在研适应症

B细胞淋巴瘤弥漫性大B细胞淋巴瘤滤泡性淋巴瘤+ [6]

原研机构

rEVO Biologics, Inc.LFB Biotechnologies SASU

在研机构

TG Therapeutics, Inc.

AstraZeneca PLCNeuraxpharm Pharmaceuticals S.L.

+ [1]

非在研机构

Laboratoire Français du Fractionnement et des Biotechnologies

最高研发阶段批准上市

首次获批日期

美国 (2022-12-28),

复发性多发性硬化

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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结构/序列

Sequence Code 15059H

来源: *****

Sequence Code 4724843L

来源: *****

关联

36

项与 Ublituximab 相关的临床试验

NCT06629428

/ Not yet recruiting早期临床1期IIT

Effects of Ublituximab on Unperturbed and Perturbed Ambulatory Functions in People with Relapsing Multiple Sclerosis

The purpose of this study is to test if ublituximab changes walking functions and fall risk in people with relapsing multiple sclerosis (RMS). Twenty-five qualified people with RMS will undergo a 48-week ublituximab treatment. Before, 24 weeks into, and after the treatment, their ambulatory function, disability status, and cognition will be assessed. Additionally, they will experience large-scale slip perturbations on a treadmill under the protection of a safety harness at the last assessment. The outcome measures will be compared across the assessments to examine the effects of ublituximab on improving their walking function, disability status, cognition, and the responses to the unexpected slip perturbation.

开始日期2024-10-01

申办/合作机构

Georgia State University

[+1]

DRKS00034406

/ RecruitingN/A

Non-interventional, prospective, multicenter study to evaluate treatment satisfaction, treatment preference, quality of life, and tolerability under treatment with Briumvi® for relapsing forms of multiple sclerosis (RMS) with active disease in daily clinical practice - Briumvi® - Real World Experience Study (BRILL Study)

开始日期2024-06-14

申办/合作机构

Neuraxpharm Pharmaceuticals S.L.

CTIS2023-509555-13-00

/ Recruiting临床1期

Pharmacokinetic/pharmacodynamic evaluation of ublituximab in patients with autoimmune diseases - TG1101-RMS-SC101

开始日期2024-05-20

申办/合作机构

TG Therapeutics, Inc.

100 项与 Ublituximab 相关的临床结果

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100 项与 Ublituximab 相关的转化医学

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100 项与 Ublituximab 相关的专利（医药）

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81

项与 Ublituximab 相关的文献（医药）

2024-11-28·Cureus Journal of Medical Science

Exploring Public Interest in Multiple Sclerosis and Its Treatment Measures in the United States: A Google Trends Analysis

Article

作者: Angadala, Sai K ; Phillips, Vidith ; Aluri, Pruthvi Sai Chowdary ; Puvvada, Chaitanya S ; Ansari, Yusuf-Zain A ; Singh, Jaskaran ; Siddiqui, Zaed S ; Deoghare, Shreya

Introduction Multiple sclerosis (MS) afflicts over 2.8 million individuals worldwide and is a leading cause of neurological impairment in young adults. This study investigates the public interest in MS and its treatment options in the United States over the past decade, utilizing Google Trends data. The aim is to analyze how search trends reflect public engagement with MS, particularly about managing relapses, slowing disease progression, alleviating symptoms, and enhancing quality of life. Methods A cross-sectional study was conducted utilizing Google Trends to analyze search interest related to MS and its treatments from January 2014 to December 2023. The data was divided into two five-year periods: 2014-2018 and 2019-2023. Specific search terms for MS and various treatment modalities were analyzed, including traditional therapies (e.g., interferon-beta, glatiramer acetate) and newer treatments (e.g., ocrelizumab, siponimod). Statistical analysis was performed using the Mann-Whitney U test to compare relative search volumes (RSV) between the two periods. Results Significant fluctuations in RSV were observed over the study period. A notable increase in RSV was found for treatments such as rituximab, ocrelizumab, ublituximab, siponimod, and ponesimod in the 2019-2023 period compared to 2014-2018 (p < 0.05). Conversely, a significant decrease in RSV was observed for glatiramer acetate, alemtuzumab, natalizumab, fingolimod, and plasmapheresis during the same periods (p < 0.05). Treatments like beta interferon, ofatumumab, and teriflunomide showed no significant change in RSV between the two periods (p > 0.05). Conclusion Dividing the search period into two five-year intervals revealed shifting public interest toward newer MS therapies over the past decade. The increased interest in recent treatments aligns with advancements in MS management and may influence patient inquiries and treatment decisions. These findings highlight the utility of Google Trends as a tool for monitoring public awareness and underscore the importance of providing accessible, accurate information to guide healthcare strategies and policymaking.

2024-11-01·Med

Recurrent late-onset neutropenia following treatment with different B cell-depleting strategies in multiple sclerosis

Article

作者: Fleischer, Vinzenz ; Protopapa, Maria ; Pape, Katrin ; Zipp, Frauke ; Schraad, Muriel ; Bittner, Stefan ; Steenken, Livia ; Steffen, Falk

BACKGROUND:

As B cell-depleting therapies in multiple sclerosis (MS) have gained significant importance in the last several years, their long-term safety profile is of considerable clinical interest. Late-onset neutropenia (LON) is a rare, but potentially severe, adverse event that was first described in patients with rheumatic disorders under therapy with rituximab. Ofatumumab was approved in 2021 for the treatment of relapsing-remitting multiple sclerosis (RRMS). Neutropenia occurred in 0.2% of patients in clinical phase 3 trials, and to date, no cases of LON have been reported under ofatumumab treatment.

METHODS:

Here, we report a case of repetitive symptomatic LON under ocrelizumab as well as ofatumumab treatment. Additionally, we review the literature on rare occurrences of LON in patients with MS, neuromyelitis optica spectrum disorder (NMOSD), and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) undergoing B cell-depleting therapies, including rituximab, ocrelizumab, ofatumumab, inebilizumab, and ublituximab.

FINDINGS:

In our case, the patient presented with repetitive symptomatic LON under ocrelizumab as well as ofatumumab treatment leading to febrile infections, subsequent use of antibiotics, and application of granulocyte-colony-stimulating factor. After repetitive episodes of LON under both B cell-depleting strategies, cladribine was subsequently initiated. A nine-month follow-up showed a normal neutrophil count and no evidence of disease activity.

CONCLUSIONS:

This case highlights the significance of symptomatic late-onset blood count changes under both ocrelizumab and ofatumumab and emphasizes the importance of continuous monitoring of the differential blood count under B cell-depleting treatment.

FUNDING:

This study was supported by the Deutsche Forschungsgemeinschaft (DFG; SFB CRC-TR-128 to F.Z., V.F., and S.B..; SFB 1080 and SFB CRC-1292 to F.Z..; and SFB/TRR 355 to S.B.) and the Hermann and Lilly Schilling Foundation (to S.B.).

2024-09-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Safety profile of first-line targeted therapies in elderly and/or comorbid chronic lymphocytic leukaemia patients (unfit subpopulation). A systematic review and network meta-analysis

Review

作者: Reczek, Monika ; Stożek-Tutro, Anita ; Kawalec, Paweł

This systematic literature review (CRD42023393903) and a Bayesian network meta-analysis (NMA) aimed to assess the relative safety profile of first-line targeted therapies (acalabrutinib, ibrutinib, obinutuzumab, ofatumumab, pirtobrutinib, ublituximab, umbralisib, venetoclax, zanubrutinib) in chronic lymphocytic leukaemia (CLL) patients with advanced age and/or comorbidities. The NMA revealed that zanubrutinib was the safest treatment option in terms of the overall safety profile (e.g., serious adverse events [AEs] grade 1-5), followed by venetoclax-obinutuzumab, which showed an advantage in terms of AEs grade 1-5. The use of Bruton's tyrosine kinase inhibitor (BTKi) monotherapy was more favourable in terms of the risk of haematological AEs, but chemoimmunotherapy showed advantages in terms of cardiovascular, gastrointestinal, and infectious AEs. The risk of secondary cancers was similar between treatments. In conclusion, targeted therapies are associated with variable and clinically relevant AEs. The therapies appear to be safer when used as monotherapy rather than in combination with immunological agents in naïve CLL patients with advanced age and/or comorbidities.

170

项与 Ublituximab 相关的新闻（医药）

2025-02-20

·GlobeNewswire-Health Care

TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum

Feb. 18, 2025 -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of presentations highlighting data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS) to be presented at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 27 – March 1, 2025, in West Palm Beach, Florida. Abstracts are now available online and can be accessed on the ACTRIMS meeting website at www.forum.actrims.org. Details of the upcoming presentations are outlined below. Poster Presentation Title: Safety and Tolerability of 30-minute Ublituximab Infusions: Updates from the ENHANCE Study Presentation Date/Time: Thursday, Feb. 27, 2025/6:45pm – 7:30pm ET Session: Poster Session 1 Abstract Number/Poster Number: 509/P107 Lead Author: Dr. John Foley – Rocky Mountain Multiple Sclerosis, Salt Lake City, Utah Poster Presentation Title: The Design of a Study to Evaluate Fc Biology and Genetic Diversity in Multiple Sclerosis Presentation Date/Time: Thursday, Feb. 27, 2025/6:00pm – 6:45pm ET Session: Poster Session 1 Abstract Number/Poster Number: 301/P194 Lead Author: Nancy Monson Ph.D. - University of Texas Southwestern Medical Center, Dallas, TX OTHER BRIUMVI RELATED PRESENTATIONS: Poster Presentation Title: Real-World Ublituximab Experience at a Single US MS Center Presentation Date/Time: Friday, Feb. 28, 2025/6:45pm – 7:30pm ET Session: Poster Session 2 Abstract Number/Poster Number: 510/P425 Lead Author: Dr. John Foley – Rocky Mountain Multiple Sclerosis, Salt Lake City, Utah Poster Presentation Title: MSDA Test Reveals Distinct Disease Activity Trajectories for Ublituximab and Teriflunomide in ULTIMATE I and II Trials Presentation Date/Time: Thursday, Feb. 27, 2025/6:00pm – 6:45pm ET Session: Poster Session 1 Abstract Number/Poster Number: 516/P048 Lead Author: Ferhan Qureshi - Octave Bioscience, Menlo Park, CA Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm. ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248). BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com. Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing- remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1 TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit www.tgtherapeutics.com, and follow us on X (Formerly Twitter) @TGTherapeutics and on LinkedIn. 1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236. The content above comes from the network. if any infringement, please contact us to modify.

临床结果疫苗

2025-01-07

·PRNewswire

Neuraxpharm to further grow branded business with the acquisition of two leading narcolepsy treatments, Provigil® and Nuvigil®

Provigil® (modafinil) and Nuvigil® (armodafinil), two of the most trusted and widely prescribed brands in the narcolepsy category, will increase Neuraxpharm's global CNS presence and support market entry into new territories including Australia BARCELONA, Spain and DÜSSELDORF, Germany, Jan. 7, 2025 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces today that it has acquired at the end of December 2024 Provigil® (modafinil) and Nuvigil® (armodafinil), both of which are indicated for the treatment of Excessive Daytime Sleepiness (EDS) in adults with narcolepsy. Neuraxpharm has acquired these products in most markets outside the US^. Provigil's main market is Europe, with significant sales in France, Spain and Italy. Nuvigil is present in international markets with significant sales in Australia and Mexico. Both Provigil and Nuvigil are orally administered CNS stimulants indicated to improve wakefulness and reduce Excessive Daytime Sleepiness (EDS) in adult patients with narcolepsy, both with and without cataplexy. This acquisition is in line with Neuraxpharm's strategy to grow strong CNS brands and bring them to increasing numbers of patients worldwide. It will enable entry into new territories such as Australia, where Neuraxpharm also plans to launch first-in-class multiple sclerosis treatment ublituximab (BRIUMVI®), and will furthermore reinforce Neuraxpharm's presence in Mexico, where the Company established an office in 2023. The transaction follows the acquisition from Sanofi of two established product portfolios in 2023 and the securing of a landmark partnership with TG Therapeutics also in 2023 to commercialise ublituximab outside the US*. In 2020, Neuraxpharm acquired market-leading child epilepsy treatment Buccolam® (oromucosal midazolam) from Takeda, and in September last year Neuraxpharm received a positive CHMP opinion from the European Medicine Agency to extend Buccolam's indication to include the treatment of epilepsy in adults. Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, commented: "Today's acquisition is an example of how Neuraxpharm can harness its neurology-focused approach, broad international platform and entrepreneurial capabilities to expand strong CNS brands. These two leading narcolepsy treatments will be added to our broad and growing CNS portfolio. We will leverage our specialisation and reach to grow these products in existing and new markets, thereby bringing market-leading treatments to more CNS patients with unmet needs around the world." No financial details of the transaction have been disclosed. ^ Republic of Korea, Japan, Thailand and the United States are not included in this acquisition. * Territories outside the United States, Canada, Mexico, and excluding certain Asian countries previously partnered. About the Neuraxpharm Group Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years. Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships, and acquisitions. The company has c.1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira. Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain. For more information, please visit SOURCE Neuraxpharm WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准并购临床结果

2024-12-07

·靶点圈

CD20在癌症免疫治疗中的最新应用汇总

- 仁域生物 - 2024年 CD20 肿瘤免疫疗法的最新进展 -从开创性的单克隆抗体到嵌合抗原受体修饰的T细胞- mAbs BsAbs CAR-T 导读 CD20在B细胞的发育、分化和激活中起关键作用，是治疗B细胞恶性肿瘤的重要靶点。抗CD20免疫疗法可特异性靶向B细胞，对其他类型的细胞影响小，停止治疗后B细胞可恢复，且不影响患者的体液免疫。图1 B 细胞分化和成熟的图表（通过红色渐变表示的 CD20 表达水平的显著增加）在当前形势下，抗CD20的免疫疗法快速发展。除了传统的单克隆抗体（mAbs）之外，还有抗体-药物偶联物（ADC）、双特异性抗体（BsAbs）和嵌合抗原受体修饰的T细胞（CAR-T）等。图2 CD20 免疫疗法的临床批准和最新突破的时间顺序尽管取得了重大进展，但与这些疗法相关的不良事件和耐药性的发展仍然是关键问题。了解和缓解这些挑战对于抗CD20免疫疗法的持续成功至关重要。 CD20抗原概述 1. CD20的结构：CD20是一种在B细胞上表达的跨膜蛋白，属于MS4A家族。其结构包括四个跨膜螺旋和两个细胞外环，是抗CD20-mAbs的主要识别表位。图3 CD20 的结构 2. CD20的功能：CD20在B细胞膜上与其他蛋白质相互作用形成纳米簇，维持B细胞静息状态。图4 CD20的表达调控机制 3. CD20的表达调控：CD20的表达受基因、转录因子、表观遗传水平等多重调控。抗CD20单克隆抗体及免疫偶联物 01 mAbs的发展抗CD20-mAbs的发展趋势是提高兼容性和降低免疫原性。第一代药物利妥昔单抗是嵌合鼠-人结构，后续的奥滨尤妥珠单抗为糖工程化人源化抗体，奥法木单抗是全人源抗体。新一代抗体免疫原性降低，与免疫效应细胞和FcRn受体的相互作用增强，半衰期延长。 02 作用机制抗CD20-mAbs通过至少四种机制发挥细胞毒性作用，包括激活补体介导的细胞毒性（CDC）、介导抗体依赖性细胞毒性（ADCC）和吞噬作用（ADCP）以及直接诱导细胞死亡。图5 抗 CD20 单克隆抗体的已知作用机制以及影响恶性 B 细胞对抗 CD20 治疗耐药性的潜在因素根据其对CD20的作用方式，可分为两类：I型mAbs（如利妥昔单抗、奥法木单抗和ublituximab）能使CD20聚集成膜脂筏，强力诱导CDC，但内化率较高；II型mAbs（如奥滨尤妥珠单抗）不诱导CD20在脂筏中聚集，CDC作用较弱，但能直接诱导细胞死亡。 03 临床应用与疗效 1 利妥昔单抗是首个用于癌症治疗的mAb，对多种B细胞恶性肿瘤有效，但其存在Trogocytosis、补体耗尽、CD20内化等耐药机制。目前与来那度胺、mTOR抑制剂等多种联合用药策略来提高其疗效。 2 奥法木单抗虽在临床前研究中CDC诱导能力更强，但临床证据有限，在某些治疗中未显示出优于其他抗CD20药物的效果。 3 Ublituximab虽未获批但在临床试验中展现出了明显疗效且探索了联合治疗，严重并发症少见。 4 奥滨尤妥珠单抗在CLL和FL的一线治疗中表现出较好疗效，其通过糖工程化修饰提高了与FcγRIII的结合能力，具有更强的ADCC活性，且不易被内化。表1 不同抗CD20单克隆抗体作用机制 04 免疫偶联物 CD20-mAbs也可作为免疫偶联物使用，包括与药物（ADCs）、毒素（免疫毒素或工程毒素体-ETBs）或放射性同位素（放射免疫偶联物）连接。但因多种因素（如增加继发性恶性肿瘤和骨髓毒性风险、经济和物流问题等）未广泛应用。表2 临床批准和测试的抗 CD20 mAb 和放射免疫偶联物 CD20双特异性抗体概述：CD20-BsAbs可同时靶向两种抗原或同一抗原的两个表位，能桥接免疫细胞与肿瘤细胞，增强细胞毒性。有多种分子格式，包括IgG样和非IgG样平台，IgG型BsAbs具有Fc区，可介导ADCC和CDC，非IgG型BsAbs主要通过直接抗原结合发挥作用。表3 临床批准和测试的 CD20xCD3 BsAbs 1 Epcoritamab是全长IgG1的CD20xCD3-BsAb。2023年获FDA和EMA批准用于r/r-DLBCL治疗。 2 Odronextamab是铰链稳定的全人IgG4的CD20xCD3-BsAb。2023年获FDA和EMA批准用于r/r-FL治疗。 3 Mosunetuzumab是全长人源化IgG1的CD20xCD3 BsAb。2022年获EMA有条件批准，2023年获FDA批准用于成人r/rFL治疗。 4 Glofitamab是异二聚体人IgG1的CD20xCD3-BsAb。2023年获FDA加速批准用于r/rDLBCL治疗，EMA也批准其有条件使用。 5 Imvotamab是IgM的CD20xCD3-BsAb。体外诱导CDC能力强，细胞因子释放少，目前正在进行首次人体临床试验，安全性和耐受性良好。 6 Plamotamab是人源化IgG1的CD20xCD3-BsAb。I期临床试验正在评估其在血液恶性肿瘤患者中的安全性和耐受性，已在部分患者中显示出临床活性。 CD20-BsAbs的副作用及预防措施副作用：抗CD20-mAbs毒性相对较低，常见副作用包括过敏反应、骨髓抑制和免疫抑制等，放射性标记抗体还有与辐射相关的毒性。措施：可通过预先使用类固醇或抗组胺药物、缓慢输注等策略降低过敏反应发生率，对于低丙种球蛋白血症可考虑静脉注射免疫球蛋白替代治疗。 CD20嵌合抗原受体修饰的T细胞图6 CD20 的 CAR 构建体 CD20 作为CAR-T细胞的靶标正在临床前和临床试验中探索。研究表明CD20 CAR-T细胞疗法是一种很有潜力的r/r-NHL治疗方法。CD20也是旨在降低抗原逃逸风险的CAR-T细胞免疫疗法的关键靶点。表4 临床测试的靶向 CD20 的 CAR-T 疗法 CD20免疫疗法的耐药性概述：耐药机制包括CD20抗原水平改变（如基因表达变化、替代剪接、内化和trogocytosis等）、免疫系统效应功能受损（如CDC和ADCC功能受影响）、遗传改变导致的信号通路变化以及肿瘤微环境的免疫抑制作用（如分泌抑制性细胞因子、过表达PD-L1等）。图7 CD20 定向免疫疗法的耐药机制应对耐药性的策略：积极探索新方法以提高免疫疗法的有效性，包括寻找新的治疗靶点、优化患者分层和采用联合治疗策略，如使用抑制补体调节蛋白的药物、联合免疫检查点抑制剂等。与CD20免疫疗法的联合治疗策略 Science & Technology 常见联合治疗方案：①与R-CHOP、R-pola-CHP等方案用于治疗DLBCL和MCL；②与venetoclax、idelalisib等靶向药物联合用于治疗CLL；③在B-ALL治疗中也与化疗或酪氨酸激酶抑制剂联合使用；④与一些新型联合疗法联用，如R-DHAP与替西罗莫司联合治疗复发/难治性DLBCL。药物相互作用与影响：联合使用的药物可能对CD20抗原表达产生双向影响，如泼尼松龙可上调CD20表达，而一些药物如伊布替尼、idelalisib等可下调CD20表达并抑制细胞毒性效应细胞，从而影响抗CD20mAbs的疗效。需要进一步研究药物诱导的细胞信号变化和CD20的表达调控关系。结论与展望 CD20靶向免疫疗法在B细胞恶性肿瘤治疗中取得了显著进展，为复发/难治性患者提供了有效治疗选择，但也面临治疗相关并发症和副作用等挑战。表5 CD20的传统mAb、双特异性抗体和CAR-T疗法的对比深入理解不同类型治疗的活性决定因素和耐药机制，对于优化治疗选择和提高临床疗效至关重要。未来的关键方向包括联合小分子药物、同时靶向多个免疫治疗靶点，以提高治疗精度并降低复发风险，同时更好地理解反应和耐药的决定因素，以实现患者的精准选择和合理联合治疗。关于仁域生物成都仁域生物成立于2019年1月，是一家专注基因工程抗体技术和天然抗体库开发的公司，拥有优化的噬菌体展示抗体库技术和现代化的骆驼/羊驼养殖免疫基地。公司核心技术平台包括全球最大的5000+天然驼源纳米抗体库(总库容＞3×10^12)、肿瘤细胞系免疫的骆驼免疫库、万亿级大容量全人源噬菌体展示scFv抗体库(总库容＞1×10^12)。可为客户提供14天、100%成功率的先导抗体分子发现服务，彻底解决传统抗体定制的周期长、失败率高、成本高三大难题。目前已经成功完成300+靶点抗体筛选项目！科研专用—万亿级天然抗体库产品（一步到位，轻松搭建基因工程抗体平台） 2024.10~11月产品限量供应 protocol 获取 / 产品咨询邮箱｜find@renyubio.com 电话｜19136178673 地址｜成都市经开区科技产业孵化园参考文献 Dabkowska A, Domka K, Firczuk M. Advancements in cancer immunotherapies targeting CD20: from pioneering monoclonal antibodies to chimeric antigen receptor-modified T cells. Front Immunol. 2024 Apr 4;15:1363102. Pavlasova G, Mraz M. The regulation and function of CD20: an "enigma" of B-cell biology and targeted therapy. Haematologica. 2020 Jun;105(6):1494-1506. Klein C, Jamois C, Nielsen T. Anti-CD20 treatment for B-cell malignancies: current status and future directions. Expert Opin Biol Ther. 2021 Feb;21(2):161-181. Basu B, Angeletti A, Islam B, Ghiggeri GM. New and Old Anti-CD20 Monoclonal Antibodies for Nephrotic Syndrome. Where We Are? Front Immunol. 2022 Feb 11;13:805697. 关注我们，持续更新相关内容

免疫疗法细胞疗法抗体药物偶联物

100 项与 Ublituximab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11243	Ublituximab	-	DB11850

研发状态

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适应症	国家/地区	公司	日期
复发性多发性硬化	美国	TG Therapeutics, Inc.	2022-12-28

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适应症	最高研发状态	国家/地区	公司	日期
弥漫性大B细胞淋巴瘤	临床3期	美国	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	澳大利亚	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	以色列	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	意大利	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	波兰	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	斯洛伐克	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	韩国	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	西班牙	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	英国	TG Therapeutics, Inc.	2016-05-25
滤泡性淋巴瘤	临床3期	美国	TG Therapeutics, Inc.	2016-05-25

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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


NCT03277248 \| NCT03277261 (ULTIMATE I and II, Pubmed \| Front Neurol)	临床3期	复发性多发性硬化 Gd+ T1 lesions \| new or enlarging T2 lesions \| Expanded Disability Status Scale score	-	Ublituximab 450 mg	醖鬱繭糧製鬱鬱願窪築(鏇鏇夢壓顧構窪簾簾窪) = 廠築餘選窪獵範鬱艱鏇範簾鏇鬱艱網襯夢襯範 (衊願顧衊鬱醖願鏇膚夢 )	积极	2024-10-24
				Teriflunomide 14 mg	醖鬱繭糧製鬱鬱願窪築(鏇鏇夢壓顧構窪簾簾窪) = 選簾糧艱艱繭製鏇顧網範簾鏇鬱艱網襯夢襯範 (衊願顧衊鬱醖願鏇膚夢 )
NCT03277248 \| NCT03277261 (ULTIMATE, Corporate Publications) 人工标引	临床1/2期	复发性多发性硬化	1,094	teriflunomide+Ublituximab	積觸築廠網憲憲廠觸願(鏇蓋鬱蓋淵範襯鬱選餘) = 製糧遞獵餘鬱鑰製蓋範壓積蓋鬱範衊築選願夢 (選艱願選廠簾遞齋鬱鏇 ) 更多	积极	2024-09-18
				Ublituximab	積觸築廠網憲憲廠觸願(鏇蓋鬱蓋淵範襯鬱選餘) = 網網襯選糧簾積範鹽窪壓積蓋鬱範衊築選願夢 (選艱願選廠簾遞齋鬱鏇 ) 更多
NCT03277248 \| NCT03277261 (ULTIMATE, Corporate Publications) 人工标引	临床3期	复发性多发性硬化	81	ublituximab	蓋廠壓餘餘蓋簾鬱蓋齋(憲獵壓淵廠壓鑰醖餘窪) = Statistically significant average treatment effects, holding baseline value, sex, and age constant, were observed for the overall DA Score and each of the 4 Disease Pathway Scores, resulting in lower scores for the ublituximab arm compared to the teriflunomide arm (p<0.05; Bonferroni corrected). 獵糧壓築齋遞積鹽艱簾 (願構觸鏇顧壓鹽構網窪 ) 更多	积极	2024-09-18
				teriflunomide
NCT05877963 (ENHANCE, Corporate Publications) 人工标引	临床3期	复发性多发性硬化	126	Ublituximab Day 1 Dose: 150 mgUblituximab Day 1 Dose: 150 mg (Non-Depleted)	廠鬱窪壓構範構鏇膚襯(膚範積醖獵壓窪糧憲鏇) = 獵獵網範廠壓夢繭積簾網夢醖鬱鑰淵選繭願蓋 (範壓壓鏇膚鹽壓鑰襯膚 ) 更多	积极	2024-09-18
				Ublituximab Day 1 Dose: 450 mgUblituximab Day 1 Dose: 450 mg (Depleted)	廠鬱窪壓構範構鏇膚襯(膚範積醖獵壓窪糧憲鏇) = 餘餘範鹹糧窪築製鬱衊網夢醖鬱鑰淵選繭願蓋 (範壓壓鏇膚鹽壓鑰襯膚 ) 更多
NCT02612311 (UNITY-CLL, CTgov)	临床3期	慢性淋巴细胞白血病	603	Ublituximab+Umbralisib (Experimental: Arm A: Ublituximab + Umbralisib)	襯鹹廠膚繭醖鬱壓築範(窪蓋鏇糧製構簾顧淵繭) = 艱製齋顧廠艱構壓夢鑰窪願壓鏇憲鏇獵鏇膚夢 (艱蓋選構製遞構衊蓋鏇, 蓋構鹽繭膚蓋願積鬱網 ~ 糧鏇艱壓鹹鏇簾廠廠齋) 更多	-	2024-05-07
				Obinutuzumab+Chlorambucil (Active Comparator: Arm B: Obinutuzumab + Chlorambucil)	襯鹹廠膚繭醖鬱壓築範(窪蓋鏇糧製構簾顧淵繭) = 簾齋蓋糧蓋鬱選廠選鹽窪願壓鏇憲鏇獵鏇膚夢 (艱蓋選構製遞構衊蓋鏇, 鑰築簾鏇遞願積選膚顧 ~ 憲網鹹繭醖鏇遞築範蓋) 更多
NCT03801525 (ULTRA-V, CTgov)	临床2/3期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤	277	Ublituximab+Venetoclax+Umbralisib (Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V))	廠壓願窪構壓鬱蓋構構(鑰製醖糧簾遞衊鏇艱蓋) = 餘製窪糧繭窪蓋襯憲齋糧製遞淵網積範醖觸膚 (廠遞醖窪簾齋鏇鑰願憲, 淵衊襯網繭鑰觸窪膚鹽 ~ 鏇觸餘衊積膚遞窪憲製) 更多	-	2024-04-19
				Ublituximab+Venetoclax+Umbralisib (Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V))	淵積獵獵淵鑰製齋齋鹹(鬱淵構醖蓋觸獵鏇醖齋) = 窪壓網顧鏇蓋餘網鏇網餘窪餘衊獵齋醖齋襯襯 (願糧觸範鹹壓積鏇簾夢, 壓廠醖膚壓鑰遞襯願膚 ~ 齋齋積膚蓋簾艱餘鏇築) 更多
AAN2024	N/A	-	-	Ublituximab 450 mg IV infusion every 24 weeks	襯願廠蓋積襯繭膚廠願(鬱鬱壓繭積遞簾壓構淵) = 糧壓壓憲製鹹願餘簾獵顧襯醖廠繭艱齋積淵衊 (蓋夢構網醖觸壓窪築窪 ) 更多	-	2024-04-09
				Teriflunomide 14 mg orally once daily	遞選積淵夢積願壓鬱鹹(繭齋衊壓選膚鑰醖築艱) = 構繭築壓廠顧構襯網製構壓鏇夢衊蓋構艱簾艱 (鑰糧網繭淵範醖鏇觸積 )
NCT05877963 (ENHANCE, ACTRIMS 12024 \| ACTRIMS 22024) 人工标引	临床3期	复发性多发性硬化	-	Ublituximab 450 mg infusion, 2 hr	願蓋廠憲糧廠襯鹹廠醖(範鏇遞衊鹽鹹獵齋醖顧) = 築鹽餘築糧窪願獵夢遞鬱繭襯築築廠憲選範艱 (構願醖糧衊鑰築觸鬱蓋 )	积极	2024-02-29
				Ublituximab 450 mg infusion, 1 hr	願蓋廠憲糧廠襯鹹廠醖(範鏇遞衊鹽鹹獵齋醖顧) = 網願膚醖淵選製餘觸積鬱繭襯築築廠憲選範艱 (構願醖糧衊鑰築觸鬱蓋 )
NCT04508647 (CTgov)	临床2期	滤泡性淋巴瘤 \| 边缘区B细胞淋巴瘤	4	Ublituximab (Ublituximab Only)	壓願顧鏇遞網鹹夢餘齋(憲鏇鏇餘衊獵壓選範醖) = 範齋齋積構願鹹觸鹹願艱鏇廠醖蓋齋遞製構顧 (淵構憲鬱鑰鏇築膚鬱鏇, 製鹽蓋製遞鬱範鏇憲築 ~ 範簾繭膚餘壓憲夢齋鏇) 更多	-	2023-11-09
				Ublituximab+Umbralisib (Ublituximab First, Then Ublituximab and Umbralisib)	壓遞構簾廠製夢願鏇鑰(遞範壓鬱構選鏇鏇築襯) = 壓願蓋網鏇壓鬱積艱鏇鬱鹹觸鏇膚鬱蓋蓋餘膚 (製積觸廠醖獵窪製艱膚, 蓋壓範鹽鬱憲簾膚選憲 ~ 壓遞蓋鏇簾廠繭廠構夢) 更多
ULTIMATE I & II (ECTRIMS2023)	临床3期	CD20	-	Ublituximab 450 mg	蓋蓋築醖廠範繭鏇簾簾(夢蓋繭蓋範壓齋構構衊) = 艱衊繭廠鹽艱範觸夢製衊襯積鏇範觸夢蓋鬱獵 (憲選製衊遞鏇願鬱構積, -0.82 ~ 13.46) 更多	积极	2023-09-30
				Teriflunomide 14 mg	蓋蓋築醖廠範繭鏇簾簾(夢蓋繭蓋範壓齋構構衊) = 製蓋襯夢襯願餘遞繭鹹衊襯積鏇範觸夢蓋鬱獵 (憲選製衊遞鏇願鬱構積, 17.77 ~ 31.96) 更多