A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug.
The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM as measured by progression-free survival (PFS) per blinded independent review committee (IRC).

开始日期2024-08-23

申办/合作机构

Kite Pharma, Inc.

[+1]

NCT05396885 / Recruiting临床2期

A Phase II Study of CART-ddBCMA for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.

开始日期2022-08-09

申办/合作机构

Kite Pharma, Inc.

[+1]

NCT04155749 / Active, not recruiting临床1期

Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up

Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.

开始日期2019-12-23

申办/合作机构

Kite Pharma, Inc.

[+1]

100 项与 Anitocabtagene autoleucel 相关的临床结果

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100 项与 Anitocabtagene autoleucel 相关的转化医学

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100 项与 Anitocabtagene autoleucel 相关的专利（医药）

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项与 Anitocabtagene autoleucel 相关的文献（医药）

2023-11-01·Blood Cancer Discovery

IVIg Use Associated with Ten-Fold Reduction of Serious Infections in Multiple Myeloma Patients Treated with Anti-BCMA Bispecific Antibodies

Article

作者: Thibaud, Santiago ; Lurie, Alaina ; Avery, Lisa ; Parekh, Samir S ; Cho, Hearn Jay ; Sanchez, Larysa J ; Lancman, Guido ; Kotlarz, Krzysztof ; Jagannath, Sundar ; Parsa, Kian ; Chari, Ajai ; Lieberman-Cribbin, Alex ; Rossi, Adriana ; Richard, Shambavi ; Richter, Joshua ; Rodriguez, Cesar

AbstractBCMA-targeted bispecific antibodies (BiAb) are efficacious in relapsed/refractory multiple myeloma; however, serious infections have emerged as important toxicities. In this retrospective study, we characterized all infections and their risk factors, and evaluated the impact of infection prophylaxis in patients treated with BCMA-targeted BiAbs. Among 37 patients, 15 (41%) experienced a grade 3–5 infection, with two infection-related deaths during deep remissions. Most (84%) infections occurred during disease remissions. The cumulative probability of grade 3–5 infection increased over time with no plateau. Among responders (n = 26), profound hypogammaglobulinemia occurred in 100% and continued throughout the entire duration of treatment. During periods when patients were receiving intravenous immunoglobulin (IVIg), the rate of grade 3–5 infections was 90% lower than during observation (incidence rate ratio, 0.10; 95% confidence interval, 0.01–0.80; P = 0.0307). No other risk factors for infection were identified. This study demonstrates that profound hypogammaglobulinemia is universal with BCMA-targeted BiAbs, with intravenous immunoglobulin potentially abrogating most of the infection risk.Significance:To the best of our knowledge, this is the first study to comprehensively analyze risk factors and mitigation strategies to prevent infections in myeloma patients receiving anti-BCMA bispecific antibodies. Profound and prolonged hypogammaglobulinemia was universal among responders, while immunoglobulin replacement was associated with 90% lower rates of grade 3–5 infections.See related commentary by Garfall and Stadtmauer, p. 427 .This article is featured in Selected Articles from This Issue, p. 419

2023-03-14·Blood Advances2区 · 医学

Phase 1 study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma

2区 · 医学

Article

作者: Cook, Daniella ; Rosenblatt, Jacalyn ; Jakubowiak, Andrzej ; Bishop, Michael R ; Logan, Emma ; Griffin, Faith ; Yee, Andrew J ; Shen, Angela ; Daley, Heather ; Frigault, Matthew J ; Shaw, Kit ; Avigan, David E ; Raje, Noopur ; Heery, Christopher ; Cornwell, Christine ; Maus, Marcela V ; O'Donnell, Elizabeth K ; Nikiforow, Sarah

AbstractRelapsed and refractory multiple myeloma (RRMM) is a plasma cell neoplasm defined by progressively refractory disease necessitating chronic and increasingly intensive therapy. Despite recent advances, limited treatment options exist for RRMM. This single-arm, open label phase 1 study aimed to evaluate the safety of novel B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T construct that leverages a completely synthetic antigen-binding domain (CART-ddBCMA), which was specifically engineered to reduce immunogenicity and improve CAR cell surface stability. Thirteen patients ≥18 years with RRMM who received at least 3 prior regimens of systemic therapy were enrolled in the study. Patients received a single dose of 100 × 106 CART-ddBCMA (DL1) or 300 × 106 CART-ddBCMA (DL2) following standard lymphodepleting chemotherapy. The primary endpoints of the study were to evaluate the incidence of treatment emergent adverse events, including dose-limiting toxicities, and establish a recommended phase 2 dose. Results showed that CART-ddBCMA was well tolerated and demonstrated a favorable toxicity profile. Only 1 case of grade ≥3 cytokine release syndrome and 1 case of immune effector cell–associated neurotoxicity were reported; both were at DL2 and were manageable with standard treatment. No atypical neurological toxicities and Parkinson disease-like movement disorders were observed. The maximum tolerated dose was not reached. All infused patients responded to CART-ddBCMA, and 9/12 (75%) patients achieved complete response/stringent complete response. Responses deepened over time, and at the time of last data-cut (median follow-up 56 weeks), 8/9 (89%) evaluable patients achieved minimal residual disease negativity. In conclusion, the findings demonstrate the safety of CART-ddBCMA cells and document durable responses to CART-ddBCMA in patients with RRMM. This trial was registered at www.clinicaltrials.gov as #NCT04155749.

2022-07-05·Molecular Cancer Therapeutics

Preclinical Efficacy of BCMA-Directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain

Article

作者: Zaritskaya, Liubov ; Richman, Laura K. ; Edwards, Justin P. ; Witter, Alexandra R. ; Gupta, Ankit ; Tice, David A. ; Hilbert, David M. ; LaFleur, David W. ; Buonato, Janine M.

AbstractChimeric antigen receptor (CAR) T-cell therapies directed against B-cell maturation antigen (BCMA) have shown compelling clinical activity and manageable safety in subjects with relapsed and refractory multiple myeloma (RRMM). Prior reported CAR T cells have mostly used antibody fragments such as humanized or murine single-chain variable fragments or camelid heavy-chain antibody fragments as the antigen recognition motif. Herein, we describe the generation and preclinical evaluation of ddBCMA CAR, which uses a novel BCMA binding domain discovered from our D domain phage display libraries and incorporates a 4-1BB costimulatory motif and CD3-zeta T-cell activation domain. Preclinical in vitro studies of ddBCMA CAR T cells cocultured with BCMA-positive cell lines showed highly potent, dose-dependent measures of cytotoxicity, cytokine production, T-cell degranulation, and T-cell proliferation. In each assay, ddBCMA CAR performed as well as the BCMA-directed scFv-based C11D5.3 CAR. Furthermore, ddBCMA CAR T cells demonstrated in vivo tumor suppression in three disseminated BCMA-expressing tumor models in NSG-immunocompromised mice. On the basis of these promising preclinical data, CART-ddBCMA is being studied in a first-in-human phase I clinical study to assess the safety, pharmacokinetics, immunogenicity, efficacy, and duration of effect for patients with RRMM (NCT04155749).

103

项与 Anitocabtagene autoleucel 相关的新闻（医药）

2024-10-03

·药明康德

2024年第四季度值得关注的9项临床试验

▎药明康德内容团队编辑行业媒体STAT今日发布了一篇文章，从诸多研发项目中挑选出了一些预计在今年第四季度公布结果的临床试验进行报道，这些试验预计将对生物医药行业产生显著影响。这些试验覆盖了广泛的研发领域，它们不仅代表了医药研发的最新成就，更有望为全球患者带来生命的转机。在本文中，药明康德内容团队将结合公开资料，与读者分享其中9项值得关注的临床试验。点击“阅读原文/Read More”即可阅读英文原文。图片来源：123RF 研发公司：安进（Amgen）疗法名称：Maridebart cafraglutide（MariTide，AMG 133）适应症：肥胖疗法类型：抗体多肽偶联药物临床试验：NCT05669599 试验阶段：2期临床试验 MariTide是一款潜在“first-in-class”的在研抗体多肽偶联药物，在靶向胃抑制肽受体（GIPR）的单克隆抗体的特定位点上偶联了两个胰高血糖素样肽1（GLP-1）类似物，在激活GLP-1受体的同时抑制GIPR。此前在Nature Metabolism上发表的1期临床试验结果显示，肥胖患者只需每月一针，接受高剂量MariTide治疗85天后，体重可降低14.5%（约26斤）。值得一提的是，这些患者在停药后150天，仍可维持体重降低11.2%。正在进行中的随机、安慰剂对照、双盲、剂量范围2期研究，旨在评估MariTide对超重或肥胖成年受试者（无论是否患有2型糖尿病）的疗效、安全性和耐受性，共招募592位患者，试验预计在今年10月初步完成。研发公司：诺和诺德（Novo Nordisk）疗法名称：CagriSema 适应症：肥胖疗法类型：多肽临床试验：REDEFINE 1（NCT05567796）、REDEFINE 2（NCT05394519）试验阶段：3期临床试验 CagriSema是一款一周一次皮下注射的司美格鲁肽（semaglutide，2.4 mg）与长效胰淀素类似物cagrilintide（2.4 mg）的固定剂量组合。在REDEFINE 1试验中，诺和诺德将检视CagriSema在约3400位没有糖尿病史的肥胖或超重患者中的减重效果；而在REDEFINE 2试验中，诺和诺德则将评估CagriSema在约1200位患有2型糖尿病（T2D）的肥胖或超重患者中的减重疗效。这两项随机3期试验预计分别在今年10月与12月初步完成。 CagriSema之前在一项为期20周的1期试验中展现积极的减重效果，CagriSema可导致患者于试验期间体重降幅达17.1%，而司美格鲁肽组患者在此数值上仅为9.8%。目前有五项CagriSema相关的临床3期试验正在进行当中。研发公司：艾伯维（AbbVie）疗法名称：Emraclidine（CVL-231）适应症：精神分裂症疗法类型：小分子临床试验：EMPOWER-1（NCT05227690）、EMPOWER-2（NCT05227703）试验阶段：2期临床试验 Cerevel Therapeutics开发的emraclidine是一款毒蕈碱M4选择性正变构调节剂（PAM），是一种潜在“best-in-class”的下一代抗精神病药物。在动物模型研究中，该分子显示出高度的脑渗透性以及与靶点特异性结合特性。艾伯维在去年12月以总额约87亿美元收购Cerevel Therapeutics囊获此款疗法。值得一提的是，emraclidine获选为猎药人网站（drughunter.com）2022年的年度小分子之一。之前公布emraclidine用于精神分裂症成人患者的早期临床数据结果显示，与安慰剂相比，emraclidine在阳性和阴性症状量表（PANSS）总分中显示出具有临床意义和统计学意义的改善，总体耐受性良好。动态血压监测试验结果显示，emraclidine长期给药不会引起精神分裂症患者血压升高。正在进行中的两项安慰剂对照2期试验共招募了约750名患者，旨在检视三种剂量的emraclidine是否能在六周内迅速缓解与精神分裂症相关的症状，包括兴奋和幻觉等“阳性”症状，以及情感退缩等“阴性”症状，试验的初步数据可能会在11月发布。研发公司：Scholar Rock 疗法名称：Apitegromab 适应症：脊髓性肌萎缩症（SMA）疗法类型：单克隆抗体临床试验：SAPPHIRE（NCT05156320）试验阶段：3期临床试验 Apitegromab是一款在研全人源单克隆抗体，通过与骨骼肌中的肌生长抑制素（myostatin）前体和潜伏形式结合，apitegromab可抑制肌生长抑制素的激活，为潜在治疗SMA的首个肌肉靶向疗法。SMA是一种罕见的进行性衰弱性运动神经元疾病，该病通常由运动神经元生存蛋白（SMN）的缺失或功能异常所致，患者肌肉的发育和生长受损，导致进行性无力和肌肉萎缩、运动功能降低、生活质量受损、甚至死亡。根据新闻稿，该疗法是在SMA领域中完成临床概念验证的首个肌肉靶向疗法。在TOPAZ临床2期试验中，在第四年时，超过90%无法行走的SMA患者在SMN靶向疗法（nusinersen或risdiplam）的基础上持续接受apitegromab治疗，研究人员并观察到患者获得持久的临床益处。相关3期试验SAPPHIRE的顶线结果预计在今年第四季度公布。研发公司：Biohaven Pharmaceuticals 疗法名称：Taldefgrobep alfa（BHV-2000）适应症：脊髓性肌萎缩症疗法类型：蛋白类药物临床试验：RESILIENT（NCT05337553）试验阶段：3期临床试验 Taldefgrobep alfa是一款肌肉生长抑制素拮抗剂和激活素1型受体抑制剂。该疗法属于一类名为adnectin的类抗体药物，旨在与肌肉生长抑制素特异性结合。Adnectin是基于人体血清中天然丰富的一种细胞外蛋白——人纤连蛋白（human fibronectin）的专有蛋白治疗类别。其内在特性与制造成功药物所需的特性一致，包括高效力、特异性、稳定性和良好的半衰期。 RESILIENT临床3期试验旨在评估taldefgrobep alfa与安慰剂相较，作为辅助疗法对已经接受稳定剂量nusinersen或risdiplam治疗或曾接受基因疗法Zolgensma（onasemnogene abeparvovec）SMA受试者的疗效和安全性。该试验结果预计在今年年底前公布。研发公司：Vertex Pharmaceuticals 疗法名称：Suzetrigine（VX-548）适应症：腰骶神经根病（LSR）疗法类型：小分子临床试验：NCT06176196 试验阶段：2期临床试验 Suzetrigine是一种口服选择性NaV1.8抑制剂，与其它NaV离子通道相比，它对NaV1.8具有高度选择性。NaV1.8是在外周神经系统的痛觉信号传导中起到关键性作用的电压门控钠通道。它是经过遗传学验证的疼痛治疗靶点。Vertex的策略是通过选择性抑制NaV1.8开发新的药物类型。该疗法用于治疗中度至重度急性疼痛的新药申请（NDA）已为美国FDA所接受并授予优先审评资格。除了用于治疗急性疼痛，suzetrigine也正在2期试验当中受检视用于治疗LSR。这是一种因腰椎区域神经根受损或损伤而引起的慢性疼痛。这项随机、双盲、安慰剂为对照的试验共招募了218名疼痛性腰骶神经根病（PLSR）患者，该试验结果预计在今年12月公布。研发公司：Alto Neuroscience 疗法名称：ALTO-100 适应症：抑郁症（MDD）疗法类型：小分子临床试验：NCT05712187 试验阶段：2b期临床试验 ALTO-100是由Alto Neuroscience利用其生物标志物平台所开发的一款口服药物，其靶点为脑源性神经营养因子（BDNF），可恢复患者的神经可塑性，使大脑能够灵活适应新信息。值得一提的是，Alto Neuroscience的精准精神病学平台通过分析脑电活动、行为表现、可穿戴设备数据、遗传学和其他因素来检测大脑生物标志物，以便为每个患者匹配合适的药物。之前公布的临床试验数据显示，ALTO-100治疗让带有生物标志物的MDD患者（n=59）在MADRS抑郁量表评分上出现15.5分的下降，此数值在不带有生物标志物的患者（n=64）身上仅为10.6分（p=0.001，d=0.6）。此外，有61%带有生物标志物的患者对该疗法产生临床应答（定义为抑郁症状减轻≥50%），而仅有33%无生物标志物的患者显示临床应答（p=0.004）。而正在进行中的2b期试验预计在这个月完成并公布结果。研发公司：Alector Therapeutics、艾伯维疗法名称：AL002 适应症：早期阿尔茨海默病（AD）疗法类型：单克隆抗体临床试验：INVOKE-2（NCT04592874）试验阶段：2期临床试验 AL002是Alector Therapeutics公司开发的在研人源化单克隆抗体，靶向骨髓细胞触发受体2（TREM2），它是散发性AD的一个重要遗传风险因素。TREM2是一种跨膜受体，在一部分先天性免疫细胞上表达，并在小胶质细胞上特异性地表达，这些细胞构成大脑的免疫系统。TREM2功能的降低可能会导致阿尔茨海默病和其他形式的痴呆症。AL002能够通过激活TREM2信号来改善细胞的存活和增殖，并增加小胶质细胞的活性，从而抵消这种功能的降低。这种活性的临床益处尚不清楚，也是AL002临床试验的重点。2017年10月，Alector Therapeutics与艾伯维达成协议，将共同开发AL002。 INVOKE-2是一项随机、双盲、安慰剂对照2期研究，旨在评估静脉注射AL002对早期阿尔茨海默病患者的疗效和安全性，共有381名患者入组。目前该研究已经完成，试验结果预计在今年第四季度公布。研发公司：Arcellx、吉利德科学（Gilead Sciences）疗法名称：Anitocabtagene autoleucel（anito-cel，CART-ddBCMA）适应症：复发或难治性多发性骨髓瘤（MM）疗法类型：细胞疗法临床试验：iMMagine-1（NCT05396885）试验阶段：2期临床试验 Anito-cel是一款BCMA靶向CAR-T细胞疗法，旨在治疗复发性或难治性MM患者。此前，该疗法已被美国FDA授予快速通道资格、孤儿药资格和再生医学先进疗法认定。之前公布的1期扩展研究结果显示，截至2023年10月15日，中位随访时间为26.5个月，共有38名患者可进行疗效和安全性分析评估。根据国际骨髓瘤工作组（IMWG）标准，所有受试者的总缓解率（ORR）达100%，并且带有预后不良因素的患者出现了深入而持久的缓解。中位PFS和OS尚未达到，Kaplan-Meier模型估计的PFS为28个月。而正在进行中的2期试验目前已招募110名复发性或难治性MM患者，初步结果预计在今年年底的美国血液学会（ASH）年会当中公布。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] The biotech scorecard for the fourth quarter: 14 stock-moving events to watch. Retrieved October 2, 2024 from https://www.statnews.com/2024/10/02/biotech-scorecard-fourth-quarter/ [2] Scholar Rock Reports Second Quarter 2024 Financial Results and Highlights Business Progress. Retrieved October 2, 2024 from https://investors.scholarrock.com/news-releases/news-release-details/scholar-rock-reports-second-quarter-2024-financial-results-and [3] Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease (REFOCUS-ALZ). Retrieved October 2, 2024 from https://clinicaltrials.gov/study/NCT05026177?intr=simufilam&limit=10&aggFilters=phase:3&rank=2 [4] Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease (RETHINK-ALZ). Retrieved October 2, 2024 from https://clinicaltrials.gov/study/NCT04994483?intr=simufilam&limit=10&aggFilters=phase:3&rank=3 [5] Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1) (iMMagine-1). Retrieved October 2, 2024 from https://clinicaltrials.gov/study/NCT05396885?intr=CART-ddBCMA&limit=10&rank=1 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床2期临床3期

2024-09-29

·药研网

Anito-Cel治疗R/R多发性骨髓瘤在I期试验中表现出显著且持久的疗效

根据第21届国际骨髓瘤协会年会上的展示数据，在一项1期试验（NCT04155749）中，BCMA的嵌合抗原受体CAR-T细胞疗法，即anitocabtagene autoleucel（anito-cel；CART-ddBCMA），显示出在复发/难治性多发性骨髓瘤患者中具有持久的疗效。总体而言，患者的响应率为100%，完全缓解和严格完全缓解（CR/sCR）率为76%。在中位随访26.5个月时，无进展生存期（PFS）、反应持续时间（DOR）和总生存期（OS）的中位数尚未达到 2 年。 Binod Dhakal博士报告称：“整个难治患者群体的中位生存期可能会超过2年”。 Binod Dhakal, MD, MS 安全性研究显示，该疗法的安全性总体可控。在整个随访期内，没有延迟性神经毒性病例、格林-巴利综合征病例、颅神经麻痹病例以及帕金森综合征病例等情况。最常见的3/4级血液学不良事件（n=38）（不包括细胞因子释放综合征或免疫效应细胞相关神经毒性综合征）是中性粒细胞减少（81.6%）、贫血（57.9%）、和血小板减少（42.1%）。在非血液学不良事件中，最常见的是高血压（7.9%）、天冬氨酸氨基转移酶水平升高（5.3%）、和蜂窝织炎（5.3%）。 Anito-cel目前正在进行关键的2期iMMAgine-1试验（NCT05396885）和全球iMMagine-3试验（NCT06413498）。这些试验将与标准疗法进行比较，涉及经过1至3次先前治疗失败后的复发/难治性多发性骨髓瘤患者中的效果。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信 wfj_GM 商务合作稿件征集点击了解详情往期回顾 1 5月| 20家药企裁员（附名单） 2 18亿美元，ADC又出海! 宜联生物宣布新授权 3 2024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布

细胞疗法临床2期临床结果ASCO会议临床1期

2024-09-25

·BioPharmaDive

Struggling 2Seventy scraps a key cancer study

2Seventy bio, the cancer-focused drugmaker spun out of Bluebird bio, has decided to stop enrolling a key study thats been evaluating its multiple myeloma therapy Abecma earlier in the treatment process.The decision announced Wednesday was made, in part, to help ensure 2Seventy breaks even financially next year. The biotechnology company expects ending the trial will save $80 million in the near term. 2Seventy recorded a $27 million loss from operations in the second quarter and, as of June 30, had about $200 million in cash, cash equivalents and marketable securities.First approved in 2021 for a narrower group of patients, Abecma this spring got cleared for use in hard-to-treat multiple myeloma cases that arent adequately controlled after two or more prior lines of therapy. The now-scrapped study was testing whether the drug benefits newly diagnosed patients who have less than optimal responses to a certain kind of stem cell transplant.Positive results may have helped 2Seventy and Bristol Myers Squibb, which co-developed the drug, compete in a market that has grown in size and intensity over the past few years. Partners Johnson & Johnson and Legend Bio have a rival cell therapy, Carvykti, that in April gained approval as a so-called second-line treatment for adults with relapsed or refractory multiple myeloma.Meanwhile, Gilead Sciences and the biotech Arcellx have been advancing a newer medicine they claim could be the best cell therapy in its class. A late-stage study of the medicine, known as anito-cel, began last month, and should produce data by 2028. The study is assessing anito-cel in participants whove already received between one and three types of treatments for their multiple myeloma.Against this background, 2Seventy and Bristol Myers acknowledged that their choice to discontinue enrollment was influenced by the greatly improved treatment landscape for newly diagnosed multiple myeloma patients. In a statement, Anna Truppel-Hartmann, 2Seventys chief medical officer, noted how this changing landscape has resulted in considerably fewer patients who are eligible for a study like the one evaluating Abecma.2Seventys CEO Chip Baird said Abecma is still showing encouraging signs of growth. U.S. revenue from the drug totaled $54 million between April and June, and 2Seventy anticipates that number rising around 30% in the third quarter. The company also anticipates patient demand for the drug to increase by double-digits compared to the second quarter.Wednesdays announcement follows a couple other moves 2Seventy made this year to tailor the business and hasten it toward profitability. In January, the company sold its pipeline of cell therapy research to Regeneron for $5 million. Then in June, it handed off a hemophilia A research program to Novo Nordisk in exchange for $38 million.Shares of 2Seventy were down 8% Wednesday, to hover around $4.40 apiece. The biotechs stock has lost more than 80% of its value since it began trading on the Nasdaq in late 2021. '

细胞疗法并购上市批准

100 项与 Anitocabtagene autoleucel 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
多发性骨髓瘤	临床3期	美国	Kite Pharma, Inc.	2024-08-23
多发性骨髓瘤	临床3期	美国	Arcellx, Inc.	2024-08-23
浆细胞骨髓瘤难治	临床2期	美国	Arcellx, Inc.	2022-08-09
浆细胞骨髓瘤难治	临床2期	美国	Kite Pharma, Inc.	2022-08-09
复发性多发性骨髓瘤	临床2期	美国	Arcellx, Inc.	2022-08-09
复发性多发性骨髓瘤	临床2期	美国	Kite Pharma, Inc.	2022-08-09

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临床结果

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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


NCT04155749 (IMS2024 \| NEWS) 人工标引	临床1期	多发性骨髓瘤	38	anitocabtagene autoleucel	(膚鑰範夢鹹膚窪廠壓觸) = One grade 5 adverse event (AE) of unrelated cardiac arrest attributed to a non-study drug overdose occurred post study. The most common grade 3/4 hematologic AEs (n = 38) that were not attributable to cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome were decreased neutrophil count (81.6%), anemia (57.9%), and thrombocytopenia (42.1%). Among non-hematologic AEs, the most common were hypertension (7.9%), increased aspartate aminotransferase levels (5.3%), and cellulitis (5.3%). 齋鑰醖鹹鹹壓窪築簾顧 (顧淵鬱鬱壓鏇壓鑰鹽製 )	积极	2024-09-24
NCT04155749 (IMS2024 \| NEWS) 人工标引	临床1期	多发性骨髓瘤	38	anitocabtagene autoleucel (patients with extramedullary disease)		积极	2024-09-24
NCT04155749 (EHA2024) 人工标引	临床1期	多发性骨髓瘤末线	40	Anitocabtagene autoleucel (anito-cel)	(膚獵襯鏇醖鏇鬱製範衊) = 簾鹽憲範餘餘糧範範壓積築觸選繭襯製窪襯獵 (廠艱餘繭網糧範觸齋艱 ) 更多	积极	2024-05-14
ASH2023 人工标引	临床1期	多发性骨髓瘤末线	38	CART-ddBCMA	(簾鏇鏇積鹽艱築廠襯夢) = 製鹽廠糧廠顧衊簾醖醖餘鏇鑰製餘鏇鏇網鬱壓 (遞淵積觸製窪遞築窪壓 ) 更多	积极	2023-12-11
PRNewswire 人工标引	临床1期	多发性骨髓瘤	38	CART-ddBCMA	(獵網鏇鹽蓋網遞糧鬱製) = 餘顧鬱餘願鑰醖膚遞鑰窪廠選餘膚蓋衊製襯選 (鏇範鹽憲窪蓋鏇鑰蓋壓 ) 更多	积极	2023-12-08
ASH2022 人工标引	临床1期	复发性多发性骨髓瘤 \| 浆细胞骨髓瘤难治	31	Fludarabine 30 mg/m2/day+Cyclophosphamide 300 mg/m2/day+CART-Ddbcma	(鬱蓋憲繭糧醖廠鏇糧壓) = 範願願壓窪鬱範糧網遞網鑰廠衊壓構襯廠鹽積 (遞觸願選構鹽製遞廠網 ) 更多	积极	2022-11-15
NCT04155749 (ARC-101, ESMO2022) 人工标引	临床1期	多发性骨髓瘤末线	25	CART-ddBCMA 100x10^6/300x10^6 CAR+T cells	(願夢憲簾簾觸壓繭獵夢) = 構餘衊獵憲淵積鹹鬱鹹鑰蓋衊製築繭窪憲鏇廠 (鏇顧齋淵襯獵鑰觸簾襯 ) 更多	积极	2022-09-10
NCT04155749 (ARC-101, ESMO2022) 人工标引	临床1期	多发性骨髓瘤末线	25	CART-ddBCMA 100x10^6/300x10^6 CAR+T cells (DL1)	(願夢憲簾簾觸壓繭獵夢) = 壓鑰範簾糧顧顧鏇膚遞鑰蓋衊製築繭窪憲鏇廠 (鏇顧齋淵襯獵鑰觸簾襯 ) 更多	积极	2022-09-10
IMS2022	临床1期	复发性多发性骨髓瘤	33	CART-ddBCMA	製膚選築鏇醖蓋醖繭襯(築遞遞鏇鹹糧顧夢築網) = 膚遞願糧築鏇選憲顧鹹憲鬱蓋獵製憲鹽鬱獵艱 (積醖願鑰糧壓製鹹繭壓 ) 更多	积极	2022-08-25
NCT04155749 (ARC-101, Corporate Publications) 人工标引	临床1期	多发性骨髓瘤	31	CART-DdBCMA	構餘鹽齋艱艱網選襯鬱(鑰獵顧網積鑰繭遞簾獵) = 餘憲觸憲壓艱艱鹽觸憲衊願願築窪齋壓壓選獵 (齋糧願遞淵繭鬱築繭築 ) 更多	积极	2022-06-03
NCT04155749 (Pubmed \| Blood Adv)	临床1期	复发性多发性骨髓瘤	-	CART-ddBCMA (DL2)	顧顧繭廠鹹鹽遞廠選膚(鏇齋築鏇齋製網襯觸衊) = 餘繭構選製醖淵範製餘夢構願繭膚鹹醖獵齋鹹 (窪繭繭繭襯壓艱膚繭襯 )	积极	2022-04-25
NCT04155749 (ARC-101, ASCO2021)	临床1期	复发性多发性骨髓瘤	10	CART-ddBCMA	衊鬱製衊鹽獵衊製鏇選(壓構襯糧襯繭製築廠醖) = 積獵衊壓壓鹹願廠製廠齋繭願窪獵獵願觸窪壓 (夢鹹築簾醖淵蓋艱獵襯, 61 ~ 87) 更多	-	2021-05-28