An International, Phase 2, Open-Label, Efficacy and Safety Study of MDV9300 in Patients With an Incomplete Response Following Salvage Therapy or Autologous Stem Cell Transplantation for Relapsed or Refractory CD20+ Diffuse Large B-Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable disease or a partial remission following definitive salvage therapy.
Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients who have received ASCT following salvage chemotherapy.

开始日期2016-12-01

申办/合作机构

MediVation, Inc.

NCT02530125

/ Terminated临床2期IIT

Phase II Study of Pidilizumab (MDV9300) in Patients With Diffuse Large B-Cell Lymphoma Following First Remission

The purpose of this study is to evaluate pidilizumab and its effect, bad and/or good, on the immune system in relation to its ability to fight cancer cells. Many cancers can be brought to a phase called complete remission (no cancer is found) but have a chance that they may come back. Researchers are working to improve therapy and to find new drugs that lower the chance of disease coming back. This study uses a drug called pidilizumab. The drug targets our immune system. It can change how our immune system finds cancer cells. The drug may kill any remaining cancer cells that we cannot see with computed tomography (CT) scans. The drug, pidilizumab, is being studied in other cancers.

开始日期2015-09-01

申办/合作机构

Northwestern University

[+2]

NCT02077959

/ Terminated临床1期IIT

Phase I/II Study of Lenalidomide in Combination With Anti-PD-1 Monoclonal Antibody CT-011 in Patients With Relapsed/Refractory Multiple Myeloma

This phase I/II trial studies the side effects and best dose of lenalidomide and pidilizumab and to see how well they work in treating patients with multiple myeloma that has come back (relapsed) or has not responded to treatment (refractory). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as pidilizumab, can block cancer growth by blocking the ability of cancer to grow and spread. Giving lenalidomide with pidilizumab may work better in treating relapsed or refractory multiple myeloma.

开始日期2014-03-03

申办/合作机构

Ohio State University Comprehensive Cancer Center

[+1]

100 项与 Pidilizumab 相关的临床结果

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100 项与 Pidilizumab 相关的转化医学

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100 项与 Pidilizumab 相关的专利（医药）

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项与 Pidilizumab 相关的文献（医药）

2022-09-22·JOURNAL OF BIOMOLECULAR STRUCTURE & DYNAMICS

Computationally-obtained structural insights into the molecular interactions between Pidilizumab and binding partners DLL1 and PD-1

Article

作者: Martins da Silva, João Hermínio ; Sartori, Geraldo Rodrigues ; Albuquerque, Aline de Oliveira ; da Silva Junior, Haroldo Cid

Pidilizumab is a monoclonal antibody tested against several types of malignancies, such as lymphoma and metastatic melanoma, showing promising results. In 2016, the FDA put Pidilizumab's clinical studies on partial hold due to emerging evidence pointing to the antibody target uncertainty. Although initial studies indicated an interaction with the PD-1 checkpoint receptor, recent updates assert that Pidilizumab binds primarily to Notch ligand DLL1. However, a detailed description of which interactions coordinate antibody-antigen complex formation is lacking. Therefore, this study uses computational tools to identify molecular interactions between Pidilizumab and its reported targets PD-1 and DLL1. A docking methodology was validated and applied to determine the binding modes between modeled Pidilizumab scFvs and the two antigens. We used Molecular Dynamics (MD) simulations to verify the complexes' stability and submitted the resulting trajectory files to MM/PBSA and Principal Component Analysis. A set of different prediction tools determined scFv interface hot-spots. Whereas docking and MD simulations revealed that the antibody fragments do not interact straightforwardly with PD-1, ten scFv hot-spots, including Met93 and Leu112, mediated the interaction with the DLL1 C2 domain. The interaction triggered a conformational selection-like effect on DLL1, allowing new hydrogen bonds on the β3-β4 interface loop. The unprecedented structural data on Pidilizumab's interactions provided novel evidence that its legitimate target is the DLL1 protein and offered structural insight on how these molecules interact, shedding light on the pathways that could be affected by the use of this essential immunobiological. Communicated by Ramaswamy H. Sarma.

2018-01-01·Journal of neuro-oncology2区 · 医学

Preliminary results of immune modulating antibody MDV9300 (pidilizumab) treatment in children with diffuse intrinsic pontine glioma

2区 · 医学

Article

作者: Toledano, Helen ; Lossos, Alex ; Yalon, Michal ; Fried, Iris ; Dvir, Rina ; Benifla, Mony ; Ben Arush, Myriam Weil ; Weintraub, Michael ; Abu Kuidar, Abed ; Postovski, Sergei ; Ben Ami, Tal

Diffuse intrinsic pontine glioma (DIPG) is an incurable disease with a median overall survival of 10 months. Immune modulating antibodies have recently emerged as a highly promising treatment modality in multiple cancer types. We present results from the first study to evaluate the immune modulating antibody MDV9300 (pidilizumab) in pediatric patients with DIPG. All patients aged 3 years and older, diagnosed with DIPG between February 2014 and June 2015 in Israel, were offered to participate in the study. Enrolled patients were started on biweekly 6 mg/kg MDV9300 after radiation completion. Treatment was continued until disease progression on imaging. Patients were followed biweekly for the occurrence of neurological deficit toxicities and side effects. Secondary endpoints were event free survival and overall survival. Of 13 children diagnosed with DIPG during the study period, nine were enrolled in the study. The patients underwent radiotherapy and none had chemotherapy. A total of 83 cycles of MDV9300 (range 2-16) were applied. The main side effects were neutropenia (CTCAE grade 1-3), mild to moderate fatigue, and acute elevation of blood pressure. Four patients died within 1 year of the diagnosis, another three died within 2 years and two children are still alive nearly 30 months from diagnosis, with stable disease. The median event free survival is 9.3 months (range 6.8-24) and the median overall survival is 15.6 months (range 6.9-28). Preliminary results demonstrate that MDV9300 treatment is safe and may be effective in the treatment of children with DIPG.

2016-04-02·Expert opinion on emerging drugs2区 · 医学

Emerging antibodies for the treatment of multiple myeloma

2区 · 医学

Review

作者: Zagouri, Flora ; Terpos, Evangelos ; Kastritis, Efstathios ; Dimopoulos, Meletios A

INTRODUCTION:

Monoclonal antibodies mark the beginning of a new era in the context of multiple myeloma (MM) treatment. Numerous antibodies have been tested or are currently in development for patients with MM, in order to improve tolerability and quality of life.

AREAS COVERED:

This manuscript reviews emerging antibodies for the treatment of MM i.e. elotuzumab, daratumumab, MOR03087, isatuximab, bevacizumab, cetuximab, siltuximab, tocilizumab, elsilimomab, azintrel, rituximab, tositumomab, milatuzumab, lucatumumab, dacetuzumab, figitumumab, dalotuzumab, AVE1642, tabalumab, pembrolizumab, pidilizumab, nivolumab.

EXPERT OPINION:

Amongst these antibodies, elotuzumab which targets SLAMF-7 and daratumumab which targets CD38, have been recently approved by FDA for patients with relapsed/refractory MM. Both agents are well tolerated. Multiple clinical trials incorporating these monoclonal antibodies in MM treatment are currently ongoing. Of special interest are the anticipated results of phase III clinical trials with elotuzumab [NCT0189164; NCT01335399; NCT02495922] and daratumumab [NCT02252172; NCT02195479] in newly diagnosed MM patients. Moreover, of great interest are the awaited data on pembrolizumabin combination with pomalidomide and dexamethasone in refractory/relapsed MM patients [NCT02576977] and in combination with lenalidomide and dexamethasone in newly diagnosed MM patients. It seems that the incorporation of monoclonal antibodies will change the landscape of myeloma therapy in the near future.

项与 Pidilizumab 相关的新闻（医药）

2024-01-20

·药明康德

首款CRISPR基因编辑疗法斩获新适应症，科济药业公布Claudin18.2靶向CAR-T疗法最新结果… | CGT周报

▎药明康德内容团队编辑近期，全球细胞和基因疗法（CGT）领域迎来系列进展。其中，Vertex公司和CRISPR Therapeutics公司联合开发的CRISPR基因编辑疗法Casgevy获得美国FDA批准，用于治疗12岁以上输血依赖性β地中海贫血（TDT）患者。它在去年12月曾获FDA批准治疗12岁及以上镰刀型细胞贫血病（SCD）患者。科济药业报告了靶向Claudin18.2的自体CAR-T细胞候选产品satri-cel（CT041），用于治疗胃癌/胃食管结合部腺癌（GC/GEJ）或胰腺癌的1b期临床试验结果。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。图片来源：123RF———✦研发进展✦———◇Vertex Pharmaceuticals宣布，与CRISPR Therapeutics联合开发的CRISPR/Cas9基因编辑疗法Casgevy（exagamglogene autotemcel，exa-cel）获美国FDA批准，用于治疗12岁及以上输血依赖性β地中海贫血（TDT）患者。在Casgevy用以治疗TDT患者的全球临床试验中，试验达到主要终点，即患者至少连续12个月不需进行输血，显示Casgevy具有一次治疗，提供功能性治愈的潜力。此前公布的试验结果显示，在接受治疗的44名TDT患者中，42名在随访时间为1.2-37.2个月时，不再需要接受输血，剩余两名患者接受的输血水平分别降低75%和89%。Casgevy是一款非病毒、自体细胞疗法，它利用CRISPR/Cas9基因编辑系统，在体外对来自患者的造血干细胞进行编辑，使血红细胞生产高水平的胎儿血红蛋白（HbF）。HbF是携带氧气的血红蛋白的一种形式，在出生时自然存在，随着婴儿的长大，血液中的血红蛋白转换为成人形式的血红蛋白。通过Casgevy治疗，可以提高HbF水平，有可能缓解输血依赖性β地中海贫血患者的输血需求。◇REGENXBIO公司近日宣布，与艾伯维（AbbVie）公司联合开发的在研基因疗法ABBV-RGX-314在治疗湿性年龄相关性黄斑变性（AMD）的2期临床试验中获得积极中期结果。接受治疗的患者表现出良好的安全性和耐受性。接受最高剂量ABBV-RGX-314治疗的患者组随后接受抗血管内皮生长因子（VEGF）治疗的需求降低达80%。ABBV-RGX-314使用腺相关病毒8（AAV8）载体携带表达抗VEGF抗体片段的转基因，在体内表达的蛋白通过阻断VEGF信号传导，抑制新血管生成和视网膜液体聚集。接受ABBV-RGX-314治疗的患者在六个月后仍显示出稳定的最佳矫正视力（BCVA）和中心视网膜厚度（CRT）。此外，在接受ABBV-RGX-314治疗后观察到抗VEGF治疗需求的显著减少，其中接受第3剂量水平治疗的患者年化注射率减少程度最高，达到80％，有50％的患者无需接受进一步注射治疗。◇科济药业在2024年美国临床肿瘤学会胃肠肿瘤研讨会（ASCO GI）上，报告了靶向Claudin18.2的自体CAR-T细胞候选产品satri-cel，用于治疗胃癌/胃食管结合部腺癌或胰腺癌的1b期临床试验结果。试验结果显示，satri-cel总体安全性令人鼓舞。没有出现噬血细胞性淋巴组织细胞增多症（HLH）、剂量限制性毒性（DLT）或治疗相关死亡。绝大多数细胞因子释放综合征（CRS）为1级，另有3例2级CRS和2例3级CRS。除1例患者出现1级免疫效应细胞相关神经毒性综合征（ICANS）外，未观察到其他任何级别的ICANS事件。截至2023年9月15日，中位随访时间为8.9个月。接受剂量3（DL3）治疗的患者中1例GC/GEJ患者达到完全缓解。所有剂量组中的GC/GEJ患者的确认客观缓解率（ORR）为42.9%（3/7）。在所有剂量组中，GC/GEJ患者的中位无进展生存期（mPFS）和中位缓解持续时间（mDOR）分别为5.7个月和6.9个月。在DL3中，GC/GEJ或PC患者的中位总生存期（mOS）为12.9个月。在所有剂量组中，GC/GEJ或PC患者的中位总生存期为8.9个月。此外，该公司还宣布，靶向磷脂酰肌醇蛋白聚糖-3（GPC3）的自体CAR-T细胞候选产品CT011已在中国获批临床，拟开发用于治疗手术切除后出现复发风险的GPC3阳性的IIIa期肝细胞癌患者。CT011是一种用于治疗肝细胞癌的自体GPC3靶向细胞候选产品，可表达整合了人源化GPC3特异性单链片段变体的嵌合抗原受体，旨在有效靶向和消除细胞表面上携带GPC3蛋白的肝细胞癌。根据科济药业公开资料，2022年8月，CT011治疗晚期肝细胞癌的长期生存案例报告已在Frontiers in Immunology杂志发表。结果显示，CT011联合索拉非尼治疗耐受性良好。患者从第3个月开始达到部分缓解（PR），并在第一个CT011输注周期后的第12个月达到完全缓解。肿瘤超过36个月没有进展，在第一次输注后保持完全缓解状态超过24个月。◇PeproMene Bio公司宣布，其靶向B细胞活化因子受体（BAFFR）的CAR-T细胞疗法PMB-CT01在治疗复发/难治性急性B淋巴细胞白血病（r/r B-ALL）的1期临床试验中获得积极结果。第1队列首例患者在治疗后一个月得到完全缓解。值得一提的是，这名患者之前接受过化疗和blinatumomab治疗后疾病复发，并且疾病复发时疾病呈CD19和CD22阴性，意味着他的可用治疗方案非常有限。PMB-CT01是一种潜在“first-in-class”的BAFFR靶向自体CAR-T细胞疗法。BAFFR是肿瘤坏死因子（TNF）受体超家族成员，是BAFF的主要受体，几乎只在B细胞上表达。由于BAFFR信号能促进正常B细胞的增殖，而且似乎是B细胞生存所必需的，因此肿瘤细胞不太可能通过失去BAFFR抗原来逃避免疫反应。这种特性使BAFFR靶向CAR-T疗法具有治疗B细胞恶性肿瘤的巨大潜力。◇诺贝尔奖得主，基因编辑先驱Jennifer Doudna教授团队在Nature Biotechnology上发表最新研究，描述了一种将基于CRISPR-Cas9的基因组编辑系统递送到特定细胞的新方法。这一技术基于抗体和抗原之间的相互作用，利用抗体片段修饰的包膜递送载体（enveloped delivery vehicles，EDVs）将基因组编辑系统递送到表达特定靶点蛋白的细胞中。研究人员表示，这一技术提供了一种可编程的递送模式，具有广泛医药应用的前景。在这项研究中，Doudna团队的科学家在生产Cas9-逆转录病毒样颗粒（VLP）复合体的细胞中表达识别CD19的抗体片段。当Cas-VLP复合体脱离细胞时，包裹在复合体表面的细胞膜上就携带着识别CD19的抗体。体外细胞培养实验发现，这些携带抗CD19抗体片段的EDV能够特异性编辑表达CD19的细胞。在对这一系统进行进一步优化后，研究人员在小鼠模型中利用Cas9-EDV成功对T细胞进行体内基因组编辑，生成了CD19靶向CAR-T细胞，这些细胞也能够有效杀死小鼠体内表达CD19的B细胞。◇Vor Bio公司宣布，其靶向CD33的同种异体CAR-T疗法VCAR33在1/2期临床试验中完成首例患者给药。这名复发/难治性急性髓系白血病（AML）患者在接受造血干细胞移植后疾病出现进展。VCAR33是基于来自健康供体的淋巴细胞生产而成，这名健康供体此前提供了移植到该患者体内的造血干细胞，因此他的细胞已经过验证与该患者匹配。通过使用来自健康供体的细胞生成的VCAR33细胞疗法具有干细胞样表型，与基于患者自身淋巴细胞制造的CAR-T细胞疗法相比，可能具有更好的扩增潜力，持久性和抗白血病活性。Vor Bio公司同时在开发通过基因工程改造，敲除CD33表达的造血干细胞trem-cel。该公司的策略是将trem-cel与VCAR33细胞疗法联用，在消灭血液癌症细胞的同时，让移植的造血干细胞不受损害，从而达到更持久的疗效。———✦合作、融资、M&A✦———◇Tr1X公司宣布走出隐匿模式，并完成7500万美元的A轮融资。该公司旨在开发通用的同种异体调节性T（Treg）和CAR-Treg细胞疗法，以治疗和潜在治愈自身免疫和炎症性疾病。Tr1X公司的管线主要基于其科学创始人Maria Grazia Roncarolo博士的工作，她是1型调节性T（Tr1）细胞的发现者。Tr1细胞是调节性T细胞的特殊亚群，对于维持健康人体内免疫平衡和耐受至关重要。在临床前模型和患者中观察到这类细胞具有几个重要的功能，包括抑制局部炎症和下调炎症小体、抑制致病性效应T细胞反应、诱导长期耐受。Tr1X的专有技术能够将从健康供体中分离出的CD4阳性T细胞转化为类Treg细胞，这些细胞具有与天然Tr1细胞相似的功能和特征。这些细胞可以进一步改造以靶向特定组织或器官，以进行局部、靶向性的免疫调节。目前，Tr1X正致力于开发其在研Tr1细胞疗法TRX103，该公司计划在1期试验中评估TRX103用以预防患者产生移植物抗宿主病（GvHD），这些患者接受了不匹配造血干细胞移植。大家都在看作为药明康德旗下专注于细胞和基因疗法的CTDMO，药明生基致力于加速和变革基因和细胞治疗及其他高端治疗的开发、测试、生产和商业化。药明生基能够助力全球客户将更多创新疗法早日推向市场，造福病患。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲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] Tr1X, Inc. Announces $75 Million Series A Financing to Develop Best-in-Class Universal Allogeneic Regulatory T (Treg) and CAR-Treg Cell Therapies to Treat and Potentially Cure Autoimmune and Inflammatory Diseases. Retrieved January 17, 2024, from https://www.prnewswire.com/news-releases/tr1x-inc-announces-75-million-series-a-financing-to-develop-best-in-class-universal-allogeneic-regulatory-t-treg-and-car-treg-cell-therapies-to-treat-and-potentially-cure-autoimmune-and-inflammatory-diseases-302036679.html[2] REGENXBIO Announces Positive Interim Data from Phase II AAVIATE® Trial of ABBV-RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery. Retrieved January 17, 2024, from https://www.prnewswire.com/news-releases/regenxbio-announces-positive-interim-data-from-phase-ii-aaviate-trial-of-abbv-rgx-314-for-the-treatment-of-wet-amd-using-suprachoroidal-delivery-302036184.html[3] Vertex Announces US FDA Approval of CASGEVY™ (exagamglogene autotemcel) for the Treatment of Transfusion-Dependent Beta Thalassemia. Retrieved January 17, 2024, from https://news.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-approval-casgevytm-exagamglogene[4] CARsgen's CT011 achieves IND clearance from the NMPA for the GPC3-positive stage Ⅲa hepatocellular carcinoma at high risk of recurrence after surgical resection. Retrieved January 17, 2024, from https://www.prnewswire.com/news-releases/carsgens-ct011-achieves-ind-clearance-from-the-nmpa-for-the-gpc3-positive-stage-a-hepatocellular-carcinoma-at-high-risk-of-recurrence-after-surgical-resection-302034257.html[5] Hamilton et al., (2024). In vivo human T cell engineering with enveloped delivery vehicles. Nat Biotechnol, https://doi-org.libproxy1.nus.edu.sg/10.1038/s41587-023-02085-z[6] PeproMene Bio, Inc. Announces Complete Remission of the Cohort 1 First Patient Treated for Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) in the Phase 1 Clinical Trial of PMB-CT01 (BAFFR-CAR T Cells) at City of Hope. Retrieved January 18, 2024, from https://www.prnewswire.com/news-releases/pepromene-bio-inc-announces-complete-remission-of-the-cohort-1-first-patient-treated-for-relapsed-and-refractory-b-cell-acute-lymphoblastic-leukemia-b-all-in-the-phase-1-clinical-trial-of-pmb-ct01-baffr-car-t-cells-at-city-o-302037365.html[7] Vor Bio Doses First AML Patient with VCAR33 (ALLO) and Provides Corporate Update. Retrieved January 18, 2024, from https://www.globenewswire.com/news-release/2024/01/17/2811112/0/en/Vor-Bio-Doses-First-AML-Patient-with-VCAR33-ALLO-and-Provides-Corporate-Update.html[8] Vor Bio Doses First AML Patient with VCAR33 (ALLO) and Provides Corporate Update. Retrieved January 18, 2024, from https://ir.vorbio.com/news-releases/news-release-details/vor-bio-doses-first-aml-patient-vcar33-allo-and-provides[9] Sensorion Announces Approval to Initiate Lead Gene Therapy Candidate SENS-501 (OTOF-GT) into a Phase 1/2 Clinical Trial in some European Countries. Retrieved January 19, 2024, from https://www.businesswire.com/news/home/20240118230763/en[10] CARsgen's Presents Updated Research Results on CT041 at 2024 ASCO GI Meeting. Retrieved January 19, 2024, from https://www.prnewswire.com/news-releases/carsgens-presents-updated-research-results-on-ct041-at-2024-asco-gi-meeting-302038279.html[11] Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients With Refractory Progressive Multiple Sclerosis. Retrieved January 19, 2024, from https://www.prnewswire.com/news-releases/kyverna-therapeutics-granted-fda-fast-track-designation-for-kyv-101-in-the-treatment-of-patients-with-refractory-progressive-multiple-sclerosis-302039087.html[12] CD19-targeted CAR NK cell therapy achieves promising one-year results in patients with B-cell malignancies. Retrieved January 19, 2024, from https://www.eurekalert.org/news-releases/1031409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

基因疗法细胞疗法临床结果临床2期免疫疗法

2024-01-15

·PRNewswire

CARsgen's CT011 achieves IND clearance from the NMPA for the GPC3-positive stage Ⅲa hepatocellular carcinoma at high risk of recurrence after surgical resection

SHANGHAI, Jan. 15, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that CT011, an autologous CAR T-cell product candidate against Glypican-3 (GPC3), has achieved Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) for patients with GPC3-positive stage IIIa hepatocellular carcinoma who are at high risk of recurrence after surgical resection. Raffaele Baffa, MD, PhD, Chief Medical Officer of CARsgen Therapeutics, commented, "Hepatocellular carcinoma (HCC) stands as the predominant histologic subtype of primary liver cancer, ranking as the sixth most prevalent cancer type globally. We initially identified GPC3 as a viable target for CAR T-cell therapy and subsequently progressed it to clinical trials for the treatment of HCC. Case report has shown patients with advanced hepatocellular carcinoma have achieved disease-free survival for more than seven years. We will continue to explore the potential of CAR-T for solid tumors and bring new treatment options for patients." About CT011 CT011 is an autologous GPC3 CAR T-cell product candidate for the treatment of hepatocellular carcinoma (HCC). CT011 received IND clearance from the NMPA in 2019 for the treatment of patients with GPC3-positive solid tumor which was China's first IND clearance for CAR T-cell therapy against solid tumors. CARsgen have completed enrollment of a Phase I trial in China. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit Public Relations: [email protected] Investor Relations: [email protected] SOURCE CARsgen Therapeutics

细胞疗法临床申请免疫疗法临床1期

2022-08-19

·PRNewswire

Case Report of Long Term Complete Response in Hepatocellular Carcinoma to CARsgen's GPC3 CAR T Cells (CT011) Published in Frontiers in Immunology

SHANGHAI, Aug. 18, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that a case report, titled " Long Term Complete Response of Advanced Hepatocellular Carcinoma to Glypican-3 Specific Chimeric Antigen Receptor T-Cells plus Sorafenib, A case report", has been published in Frontiers in Immunology (https://www.frontiersin.org/articles/10.3389/fimmu.2022.963031/full). Continue Reading Changes of the No.3 target lesion Hepatocellular carcinoma (HCC) is the most common histologic subtype of primary liver cancer, which is the sixth most common cancer type worldwide. Clinical efficacies of existing therapies for unresectable HCC are still unsatisfactory. CAR T-cell therapy has been approved for a variety of hematological tumors, but there are still great challenges for CAR T-cell therapies to treat solid tumors. We firstly reported GPC3 as a reasonable target for CAR T-cell therapy and thereafter advanced it into clinic.[1,2] In order to further enhance the efficacy of GPC3 CAR T cells, we proposed a new strategy by combining the GPC3 CAR T cells with sorafenib for the treatment of hepatocellular carcinoma[3]. To further validate this strategy in clinical setting, we conducted an investigator-initiated clinical trial at the First Affiliated Hospital of Wenzhou Medical University. The published case reported a patient with advanced HCC who achieved a complete response (CR) and a long survival period after the combination therapy of CAR-GPC3 T-cell plus sorafenib. The case showed a 60-year-old Asian male patient with hepatitis B virus (HBV)-related HCC who underwent surgery in May 2018. In August 2018, the recurrence of liver cancer and pulmonary metastasis occurred after the operation, and then he received transarterial chemoembolization (TACE) to treat liver lesions and interventional ablation to treat pulmonary metastases. Two months later, he progressed and was enrolled into the clinical trial. After the enrollment, the patient underwent leukapheresis for CAR-GPC3 T-cell manufacturing. Seven days after leukapheresis, the patient started to receive 400 mg of sorafenib twice daily. The patient received 4 cycles of CAR-GPC3 T cells (CT011) treatment and each cycle was divided into two infusions. Prior to each cycle of CT011 treatment, lymphodepletion was performed. A total of 4×109 CAR-GPC3 T cells were infused. The CT011 plus sorafenib combination therapy was well tolerated. This patient obtained partial responses (PR) from the 3rd month and achieved CR in the 12th month after the first cycle of CT011 infusion. The tumor had no progression for more than 36 months and maintained the CR status for more than 24 months after the first infusion. To the best of our knowledge, this is the first reported case with a CR after the combination therapy of CAR T cells with tyrosine kinase inhibitors. The clinical outcome demonstrated that the combination therapy of GPC3 CAR T-cell and Sorafenib may be a new promising approach for GPC3+ advanced HCC patients. Dr. Zonghai Li, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, commented that, "There is great expectation for CAR T cells to provide curative potential in treating solid tumors. When enrolled into the clinical trial, the patient in this reported case had undergone local therapies such as TACE and interventional ablation but had not received systemic therapies such as anti-angiogenesis inhibitors. Based on the finding of our earlier preclinical research, we adopted the combination therapy of sorafenib and CT011 as treatment regimens. It was very encouraging to see that the patient achieved a complete response and a long survival period without recurrence for more than two years. While directly indicating that GPC3 CAR T may be used for early-line treatment of HCC, this case report also provides new evidence supporting the adoption of CAR T cells in the early-line treatment of other solid tumors." About CT011 CT011 is an autologous CAR T-cell product candidate with proof-of-concept clinical data for the treatment of hepatocellular carcinoma (HCC) and has the potential to be the first-in-class globally. Dr. Zonghai Li — Founder, Chairman of the Board, Chief Executive Officer and Chief Scientific Officer of CARsgen Therapeutics — led the world's first successful effort in identifying, validating, and reporting GPC3 as a tumor-associated target for the development of CAR T-cell therapies to treat HCC. CARsgen has completed enrollment of a Phase I trial in China. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. The Company has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials, and commercial-scale manufacturing. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors and reducing treatment costs. The Company's vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.

抗体First in Class细胞疗法

100 项与 Pidilizumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10390	Pidilizumab	-	DB15383

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
复发性弥漫性大B细胞淋巴瘤	临床2期	美国	MediVation, Inc.	2016-12-01
转移性黑色素瘤	临床2期	美国	MediVation, Inc.	2011-11-01
转移性黑色素瘤	临床2期	以色列	MediVation, Inc.	2011-11-01
复发性滤泡性淋巴瘤	临床2期	美国	CureTech Ltd.	2010-01-01
肝细胞癌	临床2期	以色列	CureTech Ltd.	2009-10-01
慢性丙型肝炎基因型 1	临床2期	以色列	CureTech Ltd.	2009-09-01
大肠腺癌	临床2期	美国	MediVation, Inc.	2009-05-01
大肠腺癌	临床2期	保加利亚	MediVation, Inc.	2009-05-01
大肠腺癌	临床2期	印度	MediVation, Inc.	2009-05-01
大肠腺癌	临床2期	秘鲁	MediVation, Inc.	2009-05-01

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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


NCT01313416 (CTgov)	临床2期	胰腺癌	2	CT-011+gemcitabine	顧窪網憲淵積構獵窪製(齋壓鏇鹽鏇築糧膚製淵) = 製夢鏇網憲鬱餘鏇獵齋積蓋顧淵顧壓選願鹽構 (簾繭觸齋夢夢遞襯窪鹽, 廠蓋鬱遞顧餘蓋獵獵糧 ~ 餘構鹹範餘襯顧顧網鹹) 更多	-	2019-07-10
NCT01420965 (CTgov)	临床2期	去势抵抗性前列腺癌 \| 晚期前列腺癌	7	Sipuleucel-T (Provenge) (Arm A)	構遞積築蓋淵築遞構製(糧蓋夢獵衊膚鏇鏇築繭) = 簾鏇鹽廠壓醖範積鏇選淵構願構構壓齋觸鑰淵 (積淵壓鹽夢憲願蓋獵淵, 獵齋範範蓋襯顧齋廠網 ~ 膚觸觸醖餘衊襯繭憲廠) 更多	-	2019-07-10
NCT01420965 (CTgov)	临床2期	去势抵抗性前列腺癌 \| 晚期前列腺癌	7	CT-011 (Anti-PD1 Antibody)+Sipuleucel-T (Provenge) (Arm B)	構遞積築蓋淵築遞構製(糧蓋夢獵衊膚鏇鏇築繭) = 積鑰糧膚網鹽衊蓋遞襯淵構願構構壓齋觸鑰淵 (積淵壓鹽夢憲願蓋獵淵, 選簾繭鏇構觸網網夢顧 ~ 積窪醖獵餘蓋蓋構網廠) 更多	-	2019-07-10
NCT02530125 (CTgov)	临床2期	弥漫性大B细胞淋巴瘤	4	Laboratory Biomarker Analysis+Pidilizumab	遞齋構願鹹淵齋鏇餘艱(製鏇築齋廠選選製衊艱) = 夢遞醖遞齋廠觸膚觸淵醖範積鬱選襯選艱壓鹹 (製築簾構鑰構糧蓋鹽築, 製簾遞簾鹽顧窪鬱醖構 ~ 積顧憲顧遞鹽繭鹽簾壓) 更多	-	2018-03-19
NCT01441765 (CTgov)	临床2期	肾细胞癌	11	CT-011 (CT-011)	蓋築夢餘願襯夢壓齋觸(製選鹹觸膚淵夢積簾鏇) = 願壓鹹淵願廠糧糧製獵壓餘蓋觸鹹淵範壓廠蓋 (鹽範選獵鏇糧範顧範顧, 襯衊積顧鏇簾鹹糧壓觸 ~ 襯衊鹽壓製選顧糧築窪) 更多	-	2016-11-09
NCT01441765 (CTgov)	临床2期	肾细胞癌	11	DC/RCC fusion vaccine+CT-011 (CT-011 With DC/RCC Fusion Vaccine)	築膚簾衊範獵網襯積獵(選築顧顧繭顧窪範繭餘) = 構蓋淵廠齋齋簾襯觸鬱製網網淵鏇選鬱簾鬱繭 (醖蓋築繭範糧壓鏇築鹹, 願鑰醖廠觸鑰憲窪淵膚 ~ 鹽壓鑰製鹽艱餘窪獵鏇) 更多	-	2016-11-09
NCT00904722 (CTgov)	临床2期	复发性滤泡性淋巴瘤	32	Pidilizumab (CT-011	蓋製網廠獵顧蓋膚構廠(築簾構構鹽願鹽糧積蓋) = 廠鹹壓鏇顧鹽簾製獵顧選廠廠願繭齋鑰夢範製 (製壓鏇範鬱襯鏇淵繭獵, 觸窪齋夢醖製構構廠鹹 ~ 繭蓋衊夢鏇網構餘築鏇) 更多	-	2016-06-03
NCT00532259 (CTgov)	临床2期	纵隔大b细胞淋巴瘤	72	CT-011	願獵衊觸選廠製顧膚壓(膚壓膚艱鬱艱餘餘鏇廠) = 遞築鹽繭鏇淵遞簾夢簾遞壓鏇襯鑰鑰願鑰鏇積 (繭餘糧蓋艱鹹鹽觸願膚, 鑰顧醖觸網憲鹹遞膚鬱 ~ 淵遞夢餘選遞廠壓壓鑰)	-	2014-09-12
NCT01435369 (ASCO2014)	临床2期	转移性黑色素瘤	103	Pidilizumab 1.5 mg/kg	夢鑰壓選艱窪鑰獵蓋簾(廠餘廠衊膚鑰觸廠壓醖) = 21% 選遞襯積繭選觸製憲糧 (廠積顧鹹鏇鑰鬱鬱廠簾 ) 更多	-	2014-05-20
NCT01435369 (ASCO2014)	临床2期	转移性黑色素瘤	103	Pidilizumab 6 mg/kg	夢鑰壓選艱窪鑰獵蓋簾(廠餘廠衊膚鑰觸廠壓醖) = 21% 選遞襯積繭選觸製憲糧 (廠積顧鹹鏇鑰鬱鬱廠簾 ) 更多	-	2014-05-20
ICML2013	临床2期	复发性滤泡性淋巴瘤	30	Pidilizumab 3mg/kg IV q 4w	築蓋遞構壓積壓範選膚(膚壓製醖顧網鬱獵餘鏇) = 淵膚築構觸選觸鬱選積鬱艱鏇獵齋網鑰簾襯鑰 (醖簾艱獵膚蓋鹹淵膚廠 ) 更多	积极	2013-06-17