A Two-part, Open-label, Clinical Study to Assess the Safety, Tolerability and Activity of Intravenous Doses of ICT01 in Combination with Low-dose Subcutaneous Interleukin-2 in Patients with Advanced Solid Tumors (EVICTION-2)

This is a phase I/IIa, two-part, open-label study to characterize the safety, tolerability, pharmacodynamics, and antitumor activity of ICT01 in combination with LDSC IL-2 in patients with advanced-stage solid tumors.
Part 1 will be a dose escalation of IV ICT01 administered on the first day of every 21-day cycle (CnD1) to patients with advanced-stage solid tumors in combination with LDSC IL-2 (Proleukin®) administered daily on days 1-5 of cycles 1-3 (C1-3D1-5). Objectives of part 1 are to characterize the safety of the combination regimen and determine the RP2D for Part 2.
Part 2 will comprise a maximum of 2 indications and 2 combination dosing regimens of ICT01 +LDSC IL-2, which will be supported by statistical power calculations once the indications are selected. The final regimen will be ICT01 + LDSC IL-2 + Pembrolizumab on a Q3W cycle. The primary objective of Part 2 is to demonstrate the efficacy of the combination regimen based on RECIST1.1 in one or more solid tumor indications.

开始日期2022-04-19

申办/合作机构

Imcheck Therapeutics SAS初创企业

[+2]

NCT04243499

/ Active, not recruiting临床1/2期

A First-in-human, Two-part Clinical Study to Assess the Safety, Tolerability and Activity of IV Doses of ICT01 As Monotherapy and in Combination with a Checkpoint Inhibitor, in Patients with Advanced-stage, Relapsed/refractory Cancer

Part 1 will be a dose escalation study of IV ICT01 (a monoclonal antibody targeting BTN3A) as monotherapy in patients with advanced solid or hematologic tumors, followed by a cohort examining the combination of ICT01 plus pembrolizumab (Keytruda). Part 2 will be a cohort expansion into 2 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 3 solid tumor indications for the combination of ICT01 plus pembrolizumab.

开始日期2020-02-10

申办/合作机构

Imcheck Therapeutics SAS初创企业

100 项与 ICT-01 相关的临床结果

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100 项与 ICT-01 相关的转化医学

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100 项与 ICT-01 相关的专利（医药）

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项与 ICT-01 相关的文献（医药）

2021-10-20·Science translational medicine1区 · 医学

Development of ICT01, a first-in-class, anti-BTN3A antibody for activating Vγ9Vδ2 T cell–mediated antitumor immune response

1区 · 医学

Article

作者: Frohna, Paul ; Guillén, Jaime ; Collette, Yves ; De Gassart, Aude ; Castellano, Rémy ; Sims, Jennifer ; Pasero, Christine ; Hoet, René ; Agaugué, Sophie ; Olive, Daniel ; Marabelle, Aurélien ; Colazet, Magali ; Goubard, Armelle ; Truneh, Alemseged ; Joalland, Noémie ; Valentin, Emmanuel ; Scotet, Emmanuel ; Le, Kieu-Suong ; Brune, Patrick ; Cano, Carla E. ; Ghigo, Clement ; De Bonno, Johann

ICT01, a humanized BTN3A mAb, activates Vγ9Vδ2 T cell antitumor immunity and is well tolerated and pharmacodynamically active in patients.

2021-06-01·Cancer discovery1区 · 医学

Immunotherapy Activates Antitumor γ9δ2 T Cells

1区 · 医学

Article

Abstract:

Following preclinical data demonstrating that treatment with the monoclonal BNT3A antibody ICT01 can activate unique antitumor γ9δ2 T cells and encourage their trafficking to tumors, a phase I/IIa, first-in-human clinical trial of the agent is under way. Early data show corresponding results in ICT01-treated patients.

项与 ICT-01 相关的新闻（医药）

2024-12-01

·药明康德

完全缓解率达75%的T细胞激活剂；使帕金森病患者步态冻结症状完全消失的细胞疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. γ9δ2 T细胞激活剂ICT01联用阿扎胞苷和维奈托克治疗新确诊的老年和/或不适合标准治疗的急性髓系白血病（AML）患者，总完全缓解（CR）率达75%。 2. 治疗实体瘤软脑膜转移（LM）的放射治疗药物Rhenium（186Re）obisbemeda与标准的外照射放疗相比，可使中枢神经系统（CNS）蛛网膜下腔吸收的辐射剂量提高多达8倍。 3. 细胞疗法TED-A9在治疗帕金森病的1/2a期临床试验中表现亮眼，高剂量组所有3名患者的步态冻结症状完全消失。药明康德内容团队整理 ICT01：公布1/2a期临床试验数据 ImCheck Therapeutics公司公布了其新型γ9δ2 T细胞激活剂ICT01联用阿扎胞苷和维奈托克治疗新确诊的老年和/或不适合标准治疗的AML患者的积极1/2a期临床试验数据。γ9δ2 T细胞是先天免疫系统的一部分，负责对肿瘤和感染的免疫监察。ICT01是一款靶向嗜乳脂蛋白家族成员BTN3A的单克隆抗体疗法，通过与BTN3A结合，它可以选择性地激活γ9δ2 T细胞，并且促进它们迁移和浸润肿瘤，进一步激发CD8阳性T细胞和自然杀伤细胞的抗肿瘤反应。截至2024年7月19日的数据，16名疗效可评估患者的中位随访时间为4.0个月（范围0.7-7.4个月），总CR率为75%，CR/伴有血液学不完全恢复的完全缓解（CRi）率为94%。第1、2、3和4个治疗周期结束时达到CR/CRi的患者比例分别为44%、81%、88%和94%。总体而言，缓解持续时间为2.5个月，截至数据截止日期患者仍然在持续缓解。中位总生存期数据尚未成熟。 Rhenium（186Re）obisbemeda：公布1期临床试验的中期数据 Plus Therapeutics公司公布了其主打放射治疗药物Rhenium（186Re）obisbemeda治疗实体瘤软脑膜转移的临床试验ReSPECT-LM的最新数据。该疗法是一款新型可注射放疗药物，专门配制用于以安全、有效和方便的方式在CNS肿瘤中递送专一靶向的高剂量辐射，以优化患者临床结局。由于186Re的半衰期短，具有破坏癌组织的β放射能和可用于活体成像的γ放射能，是CNS治疗应用的理想放射性同位素。 20名患者接受了治疗，包括9名原发癌症为乳腺癌的患者，5名原发癌症为非小细胞肺癌的患者，以及6名原发癌症为其他癌症的患者。此次公布的结果显示，治疗后112天时，93%（14/15）患者的脑脊液循环肿瘤细胞（CTC）显示有缓解，包括1例CR和1例疾病稳定（SD）。磁共振成像（MRI）结果显示，75%（12/16）的患者获得缓解或SD，包括5例缓解和7例SD。临床应答结果显示，86%（12/14）的患者获得缓解或SD，包括2例部分缓解（PR）和10例SD。队列1-4组患者的中位总生存期为9个月，16名患者中有6人在分析时仍存活。此外，有3名患者在“同情使用”项目下接受了3次给药，这3名患者的生存时间均超过400天，其中1名患者甚至超过了30个月。新闻稿还指出，与标准的外照射放疗相比，该治疗方法可使CNS蛛网膜下腔吸收的辐射剂量提高多达8倍。 TED-A9：公布1/2a期临床的新试验数据 S.BIOMEDICS公司宣布了其细胞疗法TED-A9在治疗帕金森病的1/2a期临床试验中的首批6名受试者的1年随访数据。TED-A9是一款通过对人类胚胎干细胞（hESC）进行小分子化合物处理而生成的高度纯化中脑多巴胺能祖细胞。通过外科手术，hESC衍生的多巴胺能祖细胞被移植到患者双侧壳核的前、中、后部。移植后，这些细胞将成熟为多巴胺能神经元，通过增强帕金森病患者的神经连接，有望恢复患者的运动功能。此次公布的结果显示，根据Hoehn和Yahr量表，低剂量组（n=3）患者的运动症状平均改善了19.4%，而高剂量组（n=3）改善了44.4%，表明疾病状态从严重转向较轻。步态冻结（帕金森病患者常见的运动症状之一）在低剂量组的部分患者（1/2）中完全消失，在高剂量组的所有患者（3/3）中完全消失。神经影像技术结果显示，由移植细胞形成的突触中多巴胺转运蛋白（DAT）增加，高剂量组更为明显。安全性方面，没有观察到与移植细胞相关的问题。 INB-200：公布1期临床试验的新数据 IN8bio公司公布其耐化疗的转基因自体γδ T细胞疗法INB-200加入到胶质母细胞瘤患者的替莫唑胺（TMZ）维持治疗中的1期临床试验数据。INB-200是一种强大的协同治疗方法，能在患者接受化疗时持续存在，并保持其识别和杀死癌细胞的能力。此次公布的结果显示，92%接受INB-200协同治疗的可评估患者的无进展生存期（PFS）超过了接受标准治疗（Stupp方案）患者的中位PFS（6.9个月），大多数患者的PFS超过了基于年龄和肿瘤MGMT状态预测的PFS。此外，5名患者仍然存活，3名患者已返回工作岗位，其中1名患者在治疗后40.5个月时疾病仍然没有进展。活检结果显示，两名患者在接受INB-200治疗后，脑肿瘤微环境中持续存在着γδ T细胞以及CD3阳性和CD8阳性T细胞。安全性方面，任何队列中均未报告与治疗相关的严重不良事件、剂量限制性毒性（DLT）、细胞因子释放综合征（CRS）、输注反应或免疫效应细胞相关神经毒性（ICAN）。最常见的治疗相关不良事件是1-2级毒性，包括与标准护理TMZ相关的白细胞和血小板计数下降。 SCG101：公布1期临床试验数据星汉德生物（SCG Cell Therapy）公布了其自主研发的乙型肝炎病毒（HBV）特异性T细胞受体（TCR）-T细胞疗法SCG101的1期临床试验的新数据。SCG101是一种靶向乙型肝炎病毒表面抗原（HBsAg）的特异性自体TCR-T细胞疗法。星汉德生物依托自主研发的独有GianT技术平台，筛选高亲力且高活性的天然TCR，可以有效靶向实体肿瘤中通过主要组织相容性复合体（MHC）表达的细胞内抗原。临床前和临床研究数据显示，SCG101具有肿瘤抑制和HBV共价闭合环状DNA（cccDNA）根除作用，可实现抗肿瘤和抗病毒功能。此次公布的结果显示，SCG101在晚期HBV相关肝细胞癌（HCC）患者中显示出有希望的抗病毒活性。在接受单次静脉注射5.0×10^7-1.0×10^8个TCR-T细胞/kg剂量的SCG101治疗的12名患者中，所有患者的血清HBsAg水平均显著下降，其中11名患者（92%）的HBsAg水平下降了1.0-4.6 log10，并且在整个长达一年的随访期间，这些患者的HBsAg水平保持在100 IU/mL以下。值得注意的是，有4名患者（33%）在接受单次SCG101输注后的21天内实现了HBsAg的消失，并且这种状态持续了一整个随访期。SCG101的安全性总体上良好，治疗耐受性良好。最常见的治疗相关不良事件包括暂时性的肝酶升高、发热、细胞减少症、CRS、低白蛋白血症和低钠血症。 HL192（ATH-399A）：公布1期临床试验数据 HanAll Biopharma公司、Daewoong Pharmaceutical公司和NurrOn Pharmaceuticals公司成功完成了HL192（ATH-399A）的1期研究。HL192（ATH-399A）是一种用于治疗帕金森病的Nurr1激活剂，此前已在健康受试者中完成了一项1期研究。此次公布的结果显示，该研究在5个不同的剂量组中达到了安全性和耐受性的主要终点，表明在治疗这种使人衰弱的神经系统疾病方面迈出了有意义的一步。HL192（ATH-399A）的耐受性良好，76名受试者均无重大安全问题。接受治疗的患者与接受安慰剂的患者在治疗伴发不良事件上的发生率相当，没有明确的剂量依赖性趋势。药代动力学结果支持每天一次的给药方案。 MaaT033：公布1b期临床试验数据 MaaT Pharma公司宣布，其评估MaaT033在肌萎缩侧索硬化（ALS）患者中疗效的1b期临床试验IASO已达到主要终点。ALS患者连续服用MaaT033两个月后显示出良好的安全性和耐受性。初步的微生物组分析证实了MaaT033已成功移植，进一步支持了其安全性和耐受性结果。 MaaT033是一种源自供体、高浓度、高多样性的口腔微生物群生态系统疗法（Microbiome Ecosystem Therapy），目前正作为一种辅助疗法进行开发，以提高接受造血干细胞移植（HSCT）和其他细胞疗法的患者的总生存率。此前，MaaT033已被欧洲药品管理局（EMA）授予孤儿药资格。 ▲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（可上下滑动查看） [1] Immix Biopharma Presents Positive NXC-201 Clinical Data at 66th American Society of Hematology (ASH) Annual Meeting in 16 Relapsed/Refractory AL Amyloidosis Patients. Retrieved November 29, 2024, from https://immixbio.com/immix-biopharma-presents-positive-nxc-201-clinical-data-at-66th-american-society-of-hematology-ash-annual-meeting-in-16-relapsed-refractory-al-amyloidosis-patients/ [2] IN8bio Reports Continued Durable Remissions in Phase 1 Trial of INB-200 in Plenary Oral Presentation at the Society for Neuro-Oncology (SNO) Annual Meeting. Retrieved November 29, 2024, from https://investors.in8bio.com/news-releases/news-release-details/in8bio-reports-continued-durable-remissions-phase-1-trial-inb [3] S.BIOMEDICS Investigational Cell Therapy for Parkinson’s Disease With TED-A9 Shows Positive Data at 12-months in Phase 1/2a Clinical Trial. Retrieved November 29, 2024, from https://www.businesswire.com/news/home/20241126606645/en/S.BIOMEDICS-Investigational-Cell-Therapy-for-Parkinson%E2%80%99s-Disease-With-TED-A9-Shows-Positive-Data-at-12-months-in-Phase-12a-Clinical-Trial [4] SCG Cell Therapy Presents Promising Phase 1 Data for a Novel HBV-Specific TCR-T Therapy (SCG101) at the AASLD Liver Meeting 2024. Retrieved November 29, 2024, from https://www.prnewswire.com/news-releases/scg-cell-therapy-presents-promising-phase-1-data-for-a-novel-hbv-specific-tcr-t-therapy-scg101-at-the-aasld-liver-meeting-2024-302314896.html [5] Plus Therapeutics Presents Positive ReSPECT-LM Phase 1 Interim Data for Leptomeningeal Metastases at the 2024 SNO Annual Conference. Retrieved November 29, 2024, from https://www.globenewswire.com/news-release/2024/11/25/2986577/0/en/Plus-Therapeutics-Presents-Positive-ReSPECT-LM-Phase-1-Interim-Data-for-Leptomeningeal-Metastases-at-the-2024-SNO-Annual-Conference.html [6] 2876 ICT01, an Investigational γ9δ2 T Cell Activator, Added to Azacitidine-Venetoclax Achieves Frequent and Early Complete Remissions in Adults with AML Unfit for Intensive Induction Chemotherapy: Interim Results from the Ongoing Open-Label, Randomized Phase 1 Study Eviction. Retrieved November 29, 2024, from https://ash.confex.com/ash/2024/webprogram/Paper193493.html [7] HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals Announce Successful Completion of a First-in-Human Study for Potential Disease-Modifying Therapy for Parkinson's Disease. Retrieved November 29, 2024, from https://www.prnewswire.com/news-releases/hanall-biopharma-daewoong-pharmaceutical-and-nurron-pharmaceuticals-announce-successful-completion-of-a-first-in-human-study-for-potential-disease-modifying-therapy-for-parkinsons-disease-302315158.html [8] MaaT Pharma Announces Positive Phase 1b Results, Meeting Primary Endpoint in the Evaluation of MaaT033 in Amyotrophic Lateral Sclerosis (ALS). Retrieved November 29, 2024, from https://www.businesswire.com/news/home/20241125058999/en/MaaT-Pharma-Announces-Positive-Phase-1b-Results-Meeting-Primary-Endpoint-in-the-Evaluation-of-MaaT033-in-Amyotrophic-Lateral-Sclerosis-ALS/ [9] Hemogenyx Pharmaceuticals PLC Announces IRB Approval for Phase I Clinical Trial. Retrieved November 29, 2024, from https://www.accesswire.com/945940/hemogenyx-pharmaceuticals-plc-announces-irb-approval-for-phase-i-clinical-trial [10] GC Biopharma and Novel Pharma First Patient Dosed in Global Phase I Clinical Trial for MPS IIIA Treatment. Retrieved November 29, 2024, from https://www.prnewswire.com/news-releases/gc-biopharma-and-novel-pharma-first-patient-dosed-in-global-phase-i-clinical-trial-for-mps-iiia-treatment-302315952.html [11] Avirmax Biopharma Announces First Patient Dosed in Clinical Trial of ABI-110, a Groundbreaking Gene Therapy for Wet AMD Including PCV. Retrieved November 29, 2024, from https://www.prnewswire.com/news-releases/avirmax-biopharma-announces-first-patient-dosed-in-clinical-trial-of-abi-110-a-groundbreaking-gene-therapy-for-wet-amd-including-pcv-302313714.html [12] uniQure Announces Dosing of First Patient in GenTLE Phase I/IIa Clinical Trial of AMT-260 for the Treatment of Refractory Mesial Temporal Lobe Epilepsy. Retrieved November 29, 2024, from https://www.globenewswire.com/news-release/2024/11/21/2985098/0/en/uniQure-Announces-Dosing-of-First-Patient-in-GenTLE-Phase-I-IIa-Clinical-Trial-of-AMT-260-for-the-Treatment-of-Refractory-Mesial-Temporal-Lobe-Epilepsy.html [13] Tenaya Therapeutics Doses First Patient in RIDGE™-1 Phase 1b Clinical Trial of TN-401 for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy. Retrieved November 29, 2024, from https://investors.tenayatherapeutics.com/news-releases/news-release-details/tenaya-therapeutics-doses-first-patient-ridgetm-1-phase-1b [14] Hemogenyx Pharmaceuticals PLC Announces IRB Approval for Phase I Clinical Trial. Retrieved November 29, 2024, from https://www.accesswire.com/945940/hemogenyx-pharmaceuticals-plc-announces-irb-approval-for-phase-i-clinical-trial 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

放射疗法临床结果细胞疗法

2024-11-26

·GlobeNewswire-Health Care

ImCheck to Present Encouraging Interim Results in AML Patients from the EVICTION Trial at the 66th American Society of Hematology Annual Meeting

ImCheck to Present Encouraging Interim Results in AML Patients from the EVICTION Trial at the 66th American Society of Hematology Annual Meeting Marseille, France, November 26, 2024, 11 am CET – ImCheck Therapeutics announced today it will present positive interim results from its ongoing open-label, randomized Phase I/II study EVICTION at the 66th American Society of Hematology (ASH) Annual Meeting. The poster presentation will provide data on the novel γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in older and/or unfit patients. ICT01 is a first-in-class anti-butyrophilin 3A monoclonal antibody designed to activate γ9δ2 T cells among other immune cell classes. Data to be presented at ASH demonstrate that ICT01, both at the low and high dose levels, was safe and very well tolerated, and generated high rates of complete remission (CR) and composite CR across different molecular subgroups, particularly in TP53-mutated AML, a population with an especially poor prognosis (link to the abstract on the ASH 2024 website).Details of the poster presentation are: Abstract title: “The novel γ9δ2 T-cell activator ICT01 combined with azacitidine-venetoclax shows high rates of complete remission in older/unfit adults with newly diagnosed acute myeloid leukemia: interim results from Phase 1 study EVICTION” Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II Abstract number: 2876 Presenter: Abhishek Maiti, University of Texas MD Anderson Cancer Center Authors: Abhishek Maiti, Pierre Yves Dumas, Pierre Peterlin, Daniel Morillo, Jose Torregrosa, Paul B. Koller, Maelle Mairesse, Patrick Brune, Emmanuel Valenitn, Aude De Gassart, Katrien Lemmens, Daniel Olive, Naval Daver, Stephan Braun, and Sylvain Garciaz. Date: Sunday, Dec. 8, 2024 Time: 6:00-8:00 pm Location: Halls G-H (San Diego Convention Center) The ASH poster will be available on ImCheck’s corporate website after the poster sessions have been opened. ***About the EVICTION Study EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical study of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options. Part 1 (Phase I) is designed to characterize the preliminary safety, tolerability, and pharmacodynamic activity of increasing doses of ICT01 as monotherapy (Group A: solid tumors; Group B: hematologic tumors) and in combination with pembrolizumab (Group C: solid tumors). Group A includes urothelial cell, breast, colorectal, gastric, melanoma, ovarian, prostate, and pancreatic cancer patients, Group B includes acute myeloid leukemia, follicular lymphoma, and diffuse large B cell lymphoma patients. Group C includes urothelial cell, head-and-neck squamous cell carcinoma, melanoma, and non-small cell lung cancer patients. Part 2 is a Phase II cohort expansion study of monotherapy and combination treatment of patients with melanoma, urothelial cell, epithelial ovarian, prostate or head-and-neck squamous cell carcinoma, and acute myeloid leukemia. More information on the EVICTION study can be found at clinicaltrials.gov (NCT04243499). About ICT01ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates γ9δ2 T cells, which are part of the innate immune system that is responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia & lymphoma) and also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. As demonstrated by data presented at past AACR, ASCO, ASH, ESMO and SITC conferences, ICT01 selectively activates circulating γ9δ2 T cells leading to migration of γ9δ2 T cells out of the circulation and into the tumor tissue activating tumor-resident γ9δ2 T cells and other immune effector cells with subsequent secretion of inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in vitro and in vivo as well as in patients across several indications. About IMCHECK THERAPEUTICS ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel super-family of immunomodulators. As demonstrated by its lead clinical-stage program ICT01, which has a mechanism of action to simultaneously modulate innate and adaptive immunity, ImCheck's “first-in-class” activating antibodies may be able to produce superior clinical results as compared to the first-generation of immune checkpoint inhibitors and, when used in combination, to overcome resistance to this group of agents. In addition, ImCheck’s antagonist antibodies are being evaluated as potential treatments for a range of autoimmune and infectious diseases. ImCheck benefits from support from Prof. Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille University), a worldwide leader in γ9δ2 T cells and butyrophilins research, as well as from the experience of an expert management team and from the commitment of leading US and European investors. For further information: https://www.imchecktherapeutics.com/ Press contacts: US and EU Trophic CommunicationsGretchen Schweitzer +49 (0) 172 861 8540imcheck@trophic.eu FranceATCG PARTNERSCéline Voisin+33 (0)6 62 12 53 39imcheck@atcg-partners.com Attachment PR in English

临床结果临床2期免疫疗法临床1期ASH会议

2024-11-26

·imchecktherapeutics.com

ImCheck to Present Encouraging Interim Results in AML Patients from the EVICTION Trial at the 66th American Society of Hematology Meeting Annual Meeting

ImCheck Therapeutics announced today it will present positive interim results from its ongoing open-label, randomized Phase I/II study EVICTION at the 66th American Society of Hematology (ASH) Annual Meeting. The poster presentation will provide data on the novel γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in older and/or unfit patients. ICT01 is a first-in-class anti-butyrophilin 3A monoclonal antibody designed to activate γ9δ2 T cells among other immune cell classes. Data to be presented at ASH demonstrate that ICT01, both at the low and high dose levels, was safe and very well tolerated, and generated high rates of complete remission (CR) and composite CR across different molecular subgroups, particularly in TP53-mutated AML, a population with an especially poor prognosis (link to the abstract on the ASH 2024 website). Details of the poster presentation are: Abstract title: “The novel γ9δ2 T-cell activator ICT01 combined with azacitidine-venetoclax shows high rates of complete remission in older/unfit adults with newly diagnosed acute myeloid leukemia: interim results from Phase 1 study EVICTION” Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II Abstract number: 2876 Presenter: Abhishek Maiti, University of Texas MD Anderson Cancer Center Authors: Abhishek Maiti, Pierre Yves Dumas, Pierre Peterlin, Daniel Morillo, Jose Torregrosa, Paul B. Koller, Maelle Mairesse, Patrick Brune, Emmanuel Valenitn, Aude De Gassart, Katrien Lemmens, Daniel Olive, Naval Daver, Stephan Braun, and Sylvain Garciaz. Date: Sunday, Dec. 8, 2024 Time: 6:00-8:00 pm Location: Halls G-H (San Diego Convention Center) The ASH poster will be available on ImCheck’s corporate website after the poster sessions have been opened.

临床结果ASH会议细胞疗法临床1期AACR会议

100 项与 ICT-01 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
难治性急性髓细胞白血病	临床2期	-	Imcheck Therapeutics SAS初创企业	2023-09-11
急性淋巴细胞白血病	临床2期	美国	Imcheck Therapeutics SAS初创企业	2020-02-10
急性淋巴细胞白血病	临床2期	比利时	Imcheck Therapeutics SAS初创企业	2020-02-10
急性淋巴细胞白血病	临床2期	法国	Imcheck Therapeutics SAS初创企业	2020-02-10
急性淋巴细胞白血病	临床2期	德国	Imcheck Therapeutics SAS初创企业	2020-02-10
急性淋巴细胞白血病	临床2期	西班牙	Imcheck Therapeutics SAS初创企业	2020-02-10
急性淋巴细胞白血病	临床2期	英国	Imcheck Therapeutics SAS初创企业	2020-02-10
晚期癌症	临床2期	美国	Imcheck Therapeutics SAS初创企业	2020-02-10
晚期癌症	临床2期	比利时	Imcheck Therapeutics SAS初创企业	2020-02-10
晚期癌症	临床2期	法国	Imcheck Therapeutics SAS初创企业	2020-02-10

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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


NCT04243499 (EVICTION, SITC2024)	临床1期	难治性黑色素瘤 BTN3A tumor expression	19	ICT01 2-200 mg + Pembrolizumab 200 mg	壓齋選鏇夢艱積築齋膚(淵淵鏇獵齋築製鑰襯範) = 31% 衊蓋膚艱糧衊衊網淵齋 (蓋鬱願遞壓憲觸遞簾膚 ) 更多	积极	2024-11-05
NCT04243499 (EVICTION, SITC2024)	临床1期	尿路上皮癌 BTN3A tumor expression	26	ICT01 7 mg + Pembrolizumab 200 mg	鏇膚鑰鏇鬱憲壓餘繭製(糧網範積衊繭醖蓋淵構) = 71% 醖選範窪襯遞繭積淵觸 (膚顧觸蓋淵糧憲築蓋餘 ) 更多	积极	2024-11-05
NCT04243499 (EVICTION, SITC2024)	临床1期	尿路上皮癌 BTN3A tumor expression	26	ICT01 200 mg + Pembrolizumab 200 mg	鏇膚鑰鏇鬱憲壓餘繭製(糧網範積衊繭醖蓋淵構) = 71% 醖選範窪襯遞繭積淵觸 (膚顧觸蓋淵糧憲築蓋餘 ) 更多	积极	2024-11-05
NCT04243499 (EVICTION, ASCO2024)	临床1/2期	难治性黑色素瘤 PD-1 \| IFNg \| BTN3A ... 更多	35	ICT01 + Pembrolizumab	壓鬱醖積鹽艱遞觸壓夢(鹽醖願膚鏇鹽襯選窪遞) = 選醖淵壓積鑰積鹽壓窪糧觸衊蓋蓋蓋製遞衊簾 (壓鬱憲簾醖餘鏇襯觸簾 ) 更多	积极	2024-05-24
NCT04243499 (EVICTION, ASH2023)	临床2期	急性髓性白血病一线	-	ICT01 + Venetoclax + Azacitidine	壓積鬱鑰憲醖蓋窪鏇蓋(壓鏇廠網製壓鏇壓觸膚) = 遞鏇繭鬱網壓蓋簾襯艱繭積襯窪淵製淵構醖齋 (繭獵鹽餘獵觸蓋積範積 ) 更多	-	2023-12-09
NCT04243499 (EVICTION-2, SITC2023)	临床1/2期	晚期癌症	-	ICT01 1 mg	衊構願獵艱積鏇遞窪蓋(選膚鑰範壓簾鏇壓顧範) = Treatment-related adverse events were mainly mild to moderate infusion-related reactions, comparable to those observed with ICT01 or IL-2 monotherapy 鏇築繭窪淵壓鏇蓋選網 (膚觸齋顧窪顧積艱選廠 ) 更多	积极	2023-11-02
NCT04243499 (EVICTION-2, SITC2023)	临床1/2期	晚期癌症	-	ICT01 5 mg		积极	2023-11-02
EUCTR2019-003847-31-DE \| NCT04243499 (EVICTION, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	血液肿瘤	26	ICT01	淵製範製鏇憲壓製製餘(衊構積壓願簾選網膚鹹) = 壓艱糧觸蓋鏇醖鬱齋遞鹽膚製範願積襯夢鹹簾 (糧壓壓選膚淵鏇膚積觸 ) 更多	积极	2023-10-22
NCT04243499 (EVICTION, AACR2023) 人工标引	临床1/2期	晚期恶性实体瘤	9	ICT01 + Proleukin	範廠廠範壓蓋壓廠選獵(糧範鏇構鏇網觸廠衊鹽) = 餘築選築鹹簾遞廠顧鑰願範積鹹範鏇壓積鹹廠 (築鹽壓憲醖顧衊獵糧鹽 ) 更多	积极	2023-04-14
NCT05307874 (EVICTION-2, Corporate Publications) 人工标引	临床1/2期	实体瘤	6	ICT-01	衊鏇夢窪鏇鏇製壓壓選(網夢鑰鹽築襯糧選窪蓋) = without any new or increased adverse reactions. 願蓋鏇鏇膚遞鏇網廠鏇 (壓選襯鹽鑰簾糧鬱廠願 )	积极	2022-11-11
NCT05307874 (EVICTION-2, SITC2022)	临床1/2期	晚期恶性实体瘤	-	ICT01 1mg	壓積鑰糧顧壓網願觸範(餘積齋顧淵醖鹹襯醖窪) = rapid activation and migration of CD4 and CD8 T cells, NK cells, and granulocytes were observed on day 1 憲鑰壓淵鹹願選窪選獵 (顧觸淵觸製鑰鹽夢顧鑰 ) 更多	积极	2022-11-07
NCT05307874 (EVICTION-2, SITC2022)	临床1/2期	晚期恶性实体瘤	-	ICT01 5mg		积极	2022-11-07
NCT04243499 (EVICTION, ESMO2022) 人工标引	临床1/2期	黑色素瘤 \| 非小细胞肺癌 \| 膀胱癌二线	36	ICT01 700 mcg-200 mg+Pembrolizumab 200 mg (Melanoma)	醖齋鹹鏇選衊醖築願獵(範醖簾糧醖壓遞鏇壓衊) = 鹽壓壓繭憲膚網鑰鬱廠餘積選淵壓廠願窪蓋鬱 (鑰鏇積構願鏇繭觸選醖 ) 更多	积极	2022-09-10
NCT04243499 (EVICTION, ESMO2022) 人工标引	临床1/2期	黑色素瘤 \| 非小细胞肺癌 \| 膀胱癌二线	36	ICT01 700 mcg-200 mg+Pembrolizumab 200 mg (NSCLC)	醖齋鹹鏇選衊醖築願獵(範醖簾糧醖壓遞鏇壓衊) = 壓襯獵製夢鹹鹽夢觸製餘積選淵壓廠願窪蓋鬱 (鑰鏇積構願鏇繭觸選醖 ) 更多	积极	2022-09-10