A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma

This is a randomized, open-label study in adult patients who have completed standard first line of therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.
The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation.

开始日期2024-06-18

申办/合作机构

Allogene Therapeutics, Inc.

[+1]

NCT05714345 / Active, not recruiting临床2期

A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy

The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma

开始日期2023-03-31

申办/合作机构

Allogene Therapeutics, Inc.

NCT04416984 / Recruiting临床1/2期

A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)

This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

开始日期2020-05-21

申办/合作机构

Allogene Therapeutics, Inc.

100 项与 Cemacabtagene ansegedleucel 相关的临床结果

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100 项与 Cemacabtagene ansegedleucel 相关的转化医学

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100 项与 Cemacabtagene ansegedleucel 相关的专利（医药）

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项与 Cemacabtagene ansegedleucel 相关的文献（医药）

2001-04-01·Journal of hypertension2区 · 医学

Celiprolol stimulates endothelial nitric oxide synthase expression and improves myocardial remodeling in deoxycorticosterone acetate-salt hypertensive rats

2区 · 医学

Article

作者: Matsuoka, Hiroaki ; Kobayashi, Naohiko ; Tsubokou, Yusuke ; Nakano, Shigefumi ; Shirataki, Hiromichi ; Mori, Yousuke

OBJECTIVE:

Endothelium-dependent vasodilation is attenuated in humans and experimental hypertension models, and this phenomenon may be largely due to decreased release or activity of nitric oxide (NO). However, very few studies have evaluated whether beta-adrenoceptor antagonists increase endothelial NO synthase (eNOS) expression in the left ventricle. We examined the effects of long-term treatment with celiprolol, a specific beta1-antagonist with a weak beta2-agonist action, on eNOS expression in the left ventricle and evaluated its relationship to myocardial remodeling in the left ventricle of deoxycorticosterone acetate (DOCA)-salt hypertensive rats.

METHODS:

DOCA-salt rats (n = 18) were induced with weekly injections of DOCA (30 mg/kg) and 1% saline in their drinking water after right nephrectomy. Celiprolol (DOCA-CEL, n = 9, 10 mg/kg per day, subdepressor dose) or a vehicle (DOCA-V, n = 9) were given after induction of DOCA-salt hypertension for 5 weeks, and age-matched sham-operated rats (ShC, n = 9) served as a control group.

RESULTS:

Blood pressure levels in DOCA-V and DOCA-CEL were similar and significantly higher than that in ShC. The eNOS mRNA and protein levels, and NOS activity in the left ventricle significantly decreased in DOCA-V compared with ShC, and significantly increased in DOCA-CEL compared with DOCA-V. DOCA-V showed a significant increase in the wall-to-lumen ratio, perivascular fibrosis, myocardial fibrosis, and type I collagen mRNA, with all these parameters being significantly improved by celiprolol.

CONCLUSIONS:

Myocardial remodeling of DOCA-salt hypertensive rats was significantly ameliorated by subdepressor doses of celiprolol, which may be due to increased eNOS expression in the left ventricle.

项与 Cemacabtagene ansegedleucel 相关的新闻（医药）

2024-11-28

·循因缉药

Caribou Bio 390万美元买个清净

环球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好。最近都在忙着看财报，竟然漏了Caribou Biosciences。呃，其实也不算，在没有产品上市之前，这些biotech的财报其实最大的作用是看能活多久。只要帐上现金还有、能“忽悠”到接盘侠，也没必要经常去看。不过，最近Caribou 还是有点“花活”值得关注的。其中，一个引子就是一项集体诉讼可能要了结了。 #01 律师费109万美元 2024年11月18日，就在这个吉祥的日子（18=要发），美国一家律所 The Rosen Law Firm（下称Rosen）发布了一份公告。美国加利福尼亚北区地方法院批准了一项拟议的集体诉讼和解，2021年7月23日至2023年7月13日期间购买Caribou Biosciences的朋友们可以申请赔偿了。呃，2021年7月23日就是Caribou上市首日，假设当天买入的话到2023年7月13日也就亏了不到60%。就...还好吧。听证会定于2025年2月18日下午1:30在加利福尼亚北区地方法院举行，主要为了以下3件事：第一，是否批准包括390万美元在内的和解提案；第二，是否批准和解金分配计划；第三，是否批准首席律师申请的律师费（不超过和解金额的28%，即109.2万美元）、不超过6万美元的费用报销，以及原告代表和解类别的合理成本和费用补偿（包括工资损失）不超过7500美元；所以，美国为啥律师算高薪职业呢？那么，Caribou到底是犯了什么天条？Rosen又是哪颗葱？ #02 祸起CB-010 CB-010我们是非常熟悉了，靶向CD19的 CAR-T疗法。通过敲除TRAC基因（T细胞受体α恒定区），T细胞表面的T细胞受体（TCR）被清除，可避免移植物抗宿主反应（GvHD），敲除编码PD-1的基因，提高CAR-T细胞抗肿瘤活性的持久性。因此，这是一款创新的用于治疗B细胞非霍奇金淋巴瘤的“现货型”细胞疗法。在上市之时，CB-010是进展最快的项目，已经开展一期临床试验。那Rosen为啥要告Caribou呢？有2点：第一，CB-010的有效性并不像Caribou宣传的那么拔群；第二，CB-010的商业化前景也被Caribou夸大了；我们先看第二条。商业化前景我们大概之前聊过一些，CD19的细胞治疗实在是太多太多了。比如自体的Kymriah、Yescarta、Tecartus等都是靶向CD19，“现货型”也有来自Allogne的cema-cel，CRISPR的CTX112等等。当然，这不重要，商业化这事属于魔法范畴。最致命的是对CB-010有效性的攻击。在2022年5月份的临床试验更新中，CB-010取得了100%的ORR（客观缓解率）和80%的CR（完全缓解）。 2024年6月份的数据更新中，ORR已经被干到了76%，CR剩下了46%。你说，这算疗效不好、存在欺诈吗？似乎也不算，基于当时的数据他就是好的，基于目前的数据他就是没有那么拔群的。 Caribou又从HLA分型上进行了找补，部分匹配的患者ORR明显提升。而且，CB-010还计划开红斑狼疮适应症的临床。 2024年9月，FDA授予了CB-010快速通道认定。所以，似乎也没那么糟糕。但是，有个集体诉讼老挂在那里聒噪，也不能算个好事。这390万美元，就是买个清净啊。 #03 最后最后说一嘴Rosen。 Rosen据说是全美排名第四的证券集体诉讼律所，2019年为投资者挽回超4.38亿美元的损失。 Rosen采用完全风险代理费模式，意味着客户无需预付费用，只有在成功追回资金后才收取一定比例的费用。当然，这种模式收费一般比较高。比如，今天提到的这次诉讼，有很大一部分（最多28%）归律所所有。他们影响力最大的一次胜利应该是阿里巴巴案。 2014年7月16日，当时，中国国国家工商总局网监司在浙江召开阿里巴巴行政指导座谈会，并根据座谈情况形成了《关于对阿里巴巴集团进行行政指导工作情况的白皮书》。该白皮书列出了阿里巴巴存在的一些问题，如销售侵权商品、不合格商品和假冒伪劣产品等。后来，国家工商总局公布该白皮书后，阿里巴巴股票在2015年1月28日和29日下跌了12.8%。对此，一些西方媒体认为阿里巴巴在美国上市(2014年9月)前存在信息披露不到位的情况。最终，和解金额达到惊人的2.5亿美元，Rosen作为独家法律法律代理最多可以分到其中的25%。呃，也就是大约6000万美元。后悔啊，所有的生物人给我进来哭... 哦，对了，顺带插播一个最新消息： 2024年11 月 27 日，艺妙神州宣布，公司首款自主研发的靶向 CD19 的自体 CAR-T 细胞候选产品 IM19 嵌合抗原受体 T 细胞注射液（IM19）上市申请获 NMPA 受理，用于治疗复发或难治弥漫大 B 细胞淋巴瘤（r/r DLBCL）。 END 啊对对对对，扫描这货能联系到我至此，各位股东星标了么？点赞了么？转发了么？在看了么？谢谢！所有内容均不作为投资建议，信息均来自公开资料。近期文章： Cologuard 2.0：我们的医保很有钱呀目标50000例！纳米孔表观测序项目启动！ Guardant Health等来的正义：2.925亿美元蛋白测序明星裁员23% 安捷伦Agilent事业群重磅重组！ Twist：拜托了，总统先生相关资料：注1：https://www.globenewswire.com/news-release/2024/11/18/2982748/673/en/The-Rosen-Law-Firm-P-A-Announces-Proposed-Class-Action-Settlement-on-Behalf-of-Purchasers-of-Common-Stock-of-Caribou-Biosciences-Inc-CRBU.html注2：https://www.prnewswire.com/news-releases/crbu-investor-notice-rosen-a-leading-national-firm-encourages-caribou-biosciences-inc-investors-to-secure-counsel-before-important-deadline-in-securities-class-action--crbu-301746820.html注3：https://rosenlegal.com/case/caribou-biosciences-inc/注4：https://investor.cariboubio.com/static-files/7f40ddd9-0b0a-4d1f-80ef-9d3768aeaec6

财报基因疗法细胞疗法免疫疗法临床1期

2024-11-20

·PRNewswire

The Gene Revolution: Transforming Lives through Gene Editing Therapeutics

"The Gene Editing Therapeutics Market is all about developing advanced treatments that can directly change genes to treat or cure diseases. It's like fixing the root cause of a health issue at the DNA level, offering hope for conditions that were once thought to be untreatable. This market is rapidly growing as these innovative therapies become more widely researched and used." BOSTON, Nov. 20, 2024 /PRNewswire/ -- "According to the latest study from BCC Research, the demand for Gene Editing Therapeutics is estimated at $11 million in 2024 and is forecast to grow at a CAGR of 147% to reach $1.0 billion by the end of 2029. This report takes a close look at the current and future possibilities of gene editing treatments and explores the factors that will help or hinder their use. It also examines the competitive landscape, including what therapeutics companies are working on and how they plan to bring new treatments to market. Additionally, it predicts how the market will evolve by 2029 and provides in-depth profiles of key players, including their business focus, financials, and products. Interesting Facts about the Gene Editing Therapeutics Market The gene editing therapeutics market is just getting started, with the first approved treatment, Casgevy, coming to market in the U.K. and U.S. at the end of 2023. This groundbreaking treatment, developed by CRISPR Therapeutics and Vertex, uses CRISPR/Cas9 technology to edit genes. Casgevy's reach is expected to increase as it is set to become available for children between the ages of 5-12. While most new treatments are still in early development, two promising ones are close to a 2029 market launch: NTLA-2001 and cema-cel. There are challenges. Gene therapies are expensive and difficult to manufacture. To address this, some companies are outsourcing production and some are trying to secure government reimbursement for these life-changing treatments for rare diseases. To obtain more insights and information about the gene editing therapeutics market, click here. Factors contributing to this market's growth include: Increasing Prevalence of Chronic Diseases. More and more people are living with long-term health conditions, such as heart disease, diabetes and cancer. This trend is partly due to the world's aging population. In addition, these diseases often require ongoing treatment. Increasing Prevalence of Rare Genetic Disorders. More people are being diagnosed with uncommon, inherited health conditions caused by changes in their genes. As medical knowledge and genetic testing improve, researchers will become better at identifying these rare disorders, leading to more cases being recognized and treated. Precision Medicine.: This is a tailored approach to healthcare that focuses on treating individuals based on their unique genetic makeup, lifestyle, and environment. Instead of a one-size-fits-all method. Precision medicine provides the most effective treatment for each person, ensuring better outcomes by considering what makes each patient unique. Request a Sample Copy of the Gene Editing Therapeutics Market Report Synopsis This report addresses the following questions: What are the projections for the market? The gene editing therapeutics market is estimated at $11 million in 2024 and is forecast to grow at a CAGR of 147% to reach $1.0 billion by the end of 2029. What factors are driving the growth of the market? - Increasing prevalence of chronic diseases and rare genetic disorders. - Need for precision medicine What segments are covered in the market? Because only one product has been approved to date, with other products still under development, the market is segmented only by region. Which region has the highest market share? North America holds the highest share in the market and will continue to do so through the forecast period. Market leaders include: Allogene Therapeutics Beam Therapeutics Caribou Biosciences Inc. Crispr Therapeutics Editas Medicine Intellia Therapeutics Inc. Precision Biosciences Sangamo Therapeutics Vertex Pharmaceuticals Inc. Verve Therapeutics Inc. Vor Bio More related reports: Global Market for Cell and Gene Therapy: The worldwide industry that develops and sells treatments that use cells or genes to repair or replace damaged or diseased cells can be thought of like a repair shop for the body, where cells or genes are used to fix or replace faulty ones, helping to cure diseases and improve health. This market includes companies working on these innovative treatments. Directly Purchase a copy of the report from BCC Research. For further information or to make a purchase, please get in touch with [email protected]. About BCC Research BCC Research market reports provide objective, unbiased measurement and assessment of market opportunities. Our experienced industry analysts' goal is to help readers make informed business decisions, free of noise and hype. Contact Us Corporate HQ: 50 Milk St. Ste 16, Boston, MA 02109, USA Email: [email protected], Phone: +1 781-489-7301 For media inquiries, email [email protected] or visit our media page for access to our market research library. Any data and analysis extracted from this press release must be accompanied by a statement identifying BCC Research LLC as the source and publisher. Logo - SOURCE BCC Research LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准基因疗法

2024-11-17

·佰傲谷BioValley

通用CAR-T停止一适应症开发

日前，Allogene Therapeutics提交了一份SEC监管文件，宣布决定停止其核心管线cemacabtagene ansegedleucel（cema-cel）针对复发或难治性慢性淋巴细胞白血病（CLL）的ALPHA2临床试验的1期研究队列。这是由于百时美施贵宝（BMS）的Breyanzi获得CLL的监管批准后带来的竞争压力，使得Allogene的cema-cel针对CLL的1期研究患者入组速度放缓，因此Allogene决定削减该项目。 cema-cel是一款CD19 UCAR-T (AlloCAR-T)，是Allogene最核心的管线。 cema-cel主要被开发用于治疗大B细胞淋巴瘤（LBCL），但Allogene也一直在招募CLL患者参加cema-cel的ALPHA2试验。 Allogene报告，“新的代替治疗方案出现”后，入组速度放缓。因此，公司将停止本试验的注册，并将资源重新分配给其他项目。这是由于百时美施贵宝（BMS）的Breyanzi于今年3月获得美国FDA批准，用于治疗复发/难治性慢性淋巴细胞白血病（R/R CLL）或小淋巴细胞淋巴瘤（SLL）成人患者。这是首款用于复发性或难治性CLL或SLL成人患者的CAR-T细胞疗法。另外，归因于Breyanzi新适应症CLL/SLL和套细胞淋巴瘤（今年5月获得FDA批准）的获批，Breyanzi今年第三季度细胞治疗的全球销售额为2.24亿美元，增长143%。事实上，这对于Allogene并不是一个不能接受的事情，同样对于分析师也是如此。因为，CLL的患者基数很小，大约有40000名患者，终止该适应症的开发对于Allogene的影响并不大。同时，CLL所归属的ALPHA2试验，早在今年初就被Allogene取消了优先级。事实上，Allogene的重心早就转移到cema-cel用于LBCL一线巩固治疗的ALPHA3上。 Allogene预计将在2026年上半年完成注册，并于2026年之前获得主要EFS数据，可能于2027年提交BLA。参考资料： 1.https://www.biospace.com/business/allogene-bows-to-bms-in-leukemia-ending-phase-i-car-t-enrollment 2.https://ir.allogene.com/static-files/f2ba012a-dad3-40bc-854d-f39081f7b8bb 3.https://ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-reports-third-quarter-2024-financial 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

细胞疗法免疫疗法临床1期临床结果

100 项与 Cemacabtagene ansegedleucel 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
残留肿瘤	临床2期	美国	Allogene Therapeutics, Inc.	2024-06-18
慢性淋巴细胞白血病	临床2期	美国	Allogene Therapeutics, Inc.	2020-05-21
慢性淋巴细胞白血病	临床2期	澳大利亚	Allogene Therapeutics, Inc.	2020-05-21
慢性淋巴细胞白血病	临床2期	加拿大	Allogene Therapeutics, Inc.	2020-05-21
慢性淋巴细胞白血病	临床2期	意大利	Allogene Therapeutics, Inc.	2020-05-21
慢性淋巴细胞白血病	临床2期	西班牙	Allogene Therapeutics, Inc.	2020-05-21
大B细胞淋巴瘤	临床2期	澳大利亚	Allogene Therapeutics, Inc.	2020-05-21
大B细胞淋巴瘤	临床2期	加拿大	Allogene Therapeutics, Inc.	2020-05-21
大B细胞淋巴瘤	临床2期	意大利	Allogene Therapeutics, Inc.	2020-05-21
大B细胞淋巴瘤	临床2期	西班牙	Allogene Therapeutics, Inc.	2020-05-21