An open-label, randomized, comparative phase II study including patients with CLDN18.2-positive unresectable locally advanced gastric cancer. To evaluate the objective response rate (ORR) and progression-free survival (PFS) of IMC002 compared with investigator's choice of treatment (ICT) as third-line or later therapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression.

开始日期2025-08-06

申办/合作机构

苏州易慕峰生物科技有限公司

NCT05946226

/ Recruiting临床1期

A Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate the Safety, Feasibility, and Preliminary Efficacy of IMC002 in Patients With Claudin18.2-positive Advanced Digestive System Tumors

This is an open-label, multi-center, dose-escalation clinical study to evaluate the safety, feasibility, and preliminary efficacy of IMC002 in patients with CLDN18.2 positive digestive system tumors including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer.

开始日期2023-09-07

申办/合作机构

苏州易慕峰生物科技有限公司

CTR20231880

/ Recruiting临床1/2期

一项开放、多中心、剂量递增设计、评价IMC002在CLDN18.2表达阳性的晚期消化系统肿瘤受试者中的安全性及初步疗效的临床试验

主要目的：对CLDN18.2表达阳性的晚期消化系统肿瘤(包括但不限于晚期胃癌/食管胃结合部腺癌、晚期胰腺癌)患者进行IMC002治疗后，观察和评估患者的安全性、耐受性。次要目的：对受试者进行IMC002治疗后，根据剂量限制性毒性（DLT）和临床反应情况包括可能的副作用情况，确定推荐的II期剂量（RP2D）。评估IMC002治疗后的其他安全性指标。评估IMC002的初步抗肿瘤疗效。评估IMC002给药后的药代动力学（PK）指标、药效动力学指标的变化。探索性目的：评估IMC002给药后的生物标记物的相关变化。进行免疫原性分析、慢病毒插入位点、复制型慢病毒（RCL）等长期随访。

开始日期2023-08-22

申办/合作机构

苏州易慕峰生物科技有限公司

100 项与靶向CLDN18.2的嵌合抗原受体修饰的自体T细胞（易慕峰）相关的临床结果

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100 项与靶向CLDN18.2的嵌合抗原受体修饰的自体T细胞（易慕峰）相关的转化医学

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100 项与靶向CLDN18.2的嵌合抗原受体修饰的自体T细胞（易慕峰）相关的专利（医药）

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项与靶向CLDN18.2的嵌合抗原受体修饰的自体T细胞（易慕峰）相关的文献（医药）

MOLECULAR CANCER THERAPEUTICS

Preclinical Development and a Case Report of a Nanobody-Based CLDN18.2 CAR-T IMC002 with Reduced On-Target Off-Tumor Toxicity

Article

作者: Zhao, Chuan-Hua ; Hao, Ruidong ; Luo, Tianhang ; Sun, Minmin ; Ye, Sisi ; Li, Yuting ; Li, Chao ; Li, Yantao ; Yi, Qiaoyong ; Zhou, Jun ; Li, Juan ; Du, Sicheng ; Zhang, Shuangshuang ; Qiu, Lupeng ; Xu, Jianming ; Liu, Rong-Rui ; Zhang, Ying

Abstract:

Claudin18.2 (CLDN18.2)-targeted chimeric antigen receptor T (CAR-T) cell therapy has shown promising antitumor activity in gastrointestinal cancers. However, limited persistence in solid tumors and on-target off-tumor toxicity remain significant challenges. Here, we report on the preclinical development of a nanobody-based CLDN18.2-targeted CAR-T (IMC002) with effectiveness and safety in CLDN18.2-positive gastric and pancreatic cancers and present an efficacious clinical case. IMC002 exhibited robust antitumor activity and tolerability in multiple CLDN18.2-positive cell-derived xenograft and patient-derived xenograft models of gastric and pancreatic cancers with reduced on-target off-tumor toxicity. In vivo pharmacologic studies revealed that peak concentrations of CAR gene DNA copies in total DNA in the tumor and lung tissues occurred on 7 days after administration, whereas the peak in stomach tissues was observed an additional 7 days later. Toxicity studies showed no obvious body weight loss induced by IMC002. The highest nonseverely toxic dose was 5 × 108 CAR-T cells/kg. In the clinical case report, we present a case with unresectable advanced gastric cancer that achieved pathologic complete response 10 months after IMC002 infusion, and no signs of recurrence were indicated in subsequent clinical and radiologic follow-ups. IMC002 shows effectiveness and safety in CLDN18.2-positive gastric and pancreatic cancers, and its favorable profiles support further clinical development.

Cancer Research and Treatment

Phase 1 Study of IMC-002, a Next-Generation Anti-CD47 Antibody, in Advanced Solid Tumors

Article

作者: Kim, Heung Tae ; Lim, Ho Yeong ; Kim, Sung Ho ; Ock, Chan-Young ; Park, Joon Oh ; Lee, Sung Young ; Hwang, Woochan ; Yun, Hwi-Yeol ; Kim, SuYeon ; Hong, Jung Yong ; Ahn, Jin Seok

Purpose:

IMC-002 is a fully human cluster of differentiation 47-targeted immunoglobulin G4 monoclonal antibody, designed to minimize off-target effects. This study (NCT05276310) assessed its safety/tolerability and preliminary anti-tumor activity in patients with advanced solid tumors who were not eligible for or had progressed on standard treatment.

Materials and Methods:

Here we report results from the initial 3 + 3 design dose-escalation part of a two-part Phase 1, open-label, dose-escalation/expansion study. IMC-002 was administered intravenously every 2 weeks at four doses (5, 10, 20, and 30 mg/kg). The primary objective was to assess safety/tolerability, including maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Secondary objectives included pharmacokinetics and clinical activity, including best overall response (BOR), disease control rate (DCR), and clinical benefit rate (CBR).

Results:

Twelve patients were included in total, with three per dose level. Most patients (11/12) had stage IV disease; 7/12 had received three prior systemic therapies. No dose-limiting toxicities were observed and MTD was not reached. The most common treatment-related adverse events (TRAEs) were rash (9/12), vitreous floaters (8/12), and (hemolytic) anemia (5/12). There was no treatment-related thrombocytopenia, neutropenia, or infection. IMC-002 had dose-proportional pharmacokinetics, achieving steady state levels from Cycle 2. BOR was stable disease in six patients (DCR 50.0%). CBR was 33% (four patients maintaining disease control for ≥6 months).

Conclusion:

IMC-002 demonstrated favorable safety/tolerability at doses of 5-30 mg/kg every 2 weeks. RP2D was defined as 20 mg/kg every 3 weeks. Preliminary anti-tumor activity was observed, with a CBR of 33%.

项与靶向CLDN18.2的嵌合抗原受体修饰的自体T细胞（易慕峰）相关的新闻（医药）

2025-12-16

·医药地理

易慕峰自体CAR-T获FDA再生医学先进疗法认定

12月16日，易慕峰生物宣布，其自主研发的靶向Claudin18.2（CLDN18.2）的自体CAR-T细胞治疗产品IMC002，已获得美国食品药品监督管理局（FDA）授予的“再生医学先进疗法”（Regenerative Medicine Advanced Therapy, RMAT）认定。该认定基于FDA确认，IMC002用于治疗CLDN18.2阳性、不可切除的局部晚期或复发性/转移性胃癌/胃食管结合部癌，且既往接受过至少二线系统性治疗失败的患者，符合RMAT资格标准。 IMC002是一款基于高特异性纳米抗体平台开发的CAR-T细胞治疗产品。其临床前研究数据及一例显示病理完全缓解（pCR）的临床病例报告，此前已发表于国际肿瘤学期刊《Molecular Cancer Therapeutics》，该患者单药单次回输后至今近三年，随访期间未发现肿瘤复发，持续保持完全缓解状态。在中国已完成I/IIa期注册临床研究，该产品初步展现出良好的安全性与疗效潜力。目前，IMC002的III期确证性临床试验正在中国加速推进，全国超过30家临床中心陆续启动，晚期胃癌患者入组工作同步加速。与此同时，该产品的全球开发策略也在稳步推进，已于2025年3月获得FDA对End of Phase I（EOP 1）会议的反馈，适时启动在美国的关键临床研究。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001 获取更多创新药情报请关注【医药地理数据库】

2025-12-16

·细胞治疗前沿

易慕峰靶向Claudin18.2自体CAR-T获FDA再生医学先进疗法认定

2025年12月16日，易慕峰生物宣布，其自主研发的靶向Claudin18.2（CLDN18.2）的自体CAR-T细胞治疗产品IMC002，已获得美国食品药品监督管理局（FDA）授予的“再生医学先进疗法”（RMAT）认定。该认定基于FDA确认，IMC002用于治疗CLDN18.2阳性、不可切除的局部晚期或复发性/转移性胃癌/胃食管结合部癌，且既往接受过至少二线系统性治疗失败的患者，符合RMAT资格标准。 IMC002是一款基于高特异性纳米抗体平台开发的CAR-T细胞治疗产品。其临床前研究数据及一例显示病理完全缓解（pCR）的临床病例报告，此前已发表于国际肿瘤学期刊《Molecular Cancer Therapeutics》，该患者单药单次回输后至今近三年，随访期间未发现肿瘤复发，持续保持完全缓解状态。在中国已完成I/IIa期注册临床研究，该产品初步展现出良好的安全性与疗效潜力。目前，IMC002的III期确证性临床试验正在中国加速推进，全国超过30家临床中心陆续启动，晚期胃癌患者入组工作同步加速。与此同时，该产品的全球开发策略也在稳步推进，已于2025年3月获得FDA对End of Phase I（EOP 1）会议的反馈，适时启动在美国的关键临床研究。易慕峰是一家致力于突破实体瘤治疗，给全球患者带来长期生存获益的免疫细胞治疗药物开发企业。公司由科学家和产业精英合作组建，于2020年9月启动运营，核心成员成功推动了中国首个CAR-T药物的上市申请，具有丰富的细胞药物开发和产业化经验。易慕峰从实体瘤治疗痛点和临床获益出发，在全球范围内首次提出“化实体瘤为血液瘤”的临床策略，并在此基础上开发了Peri Cruiser®技术平台，同时还开发了SNR, T-Booster, Solid Guard, In Vivo等技术平台，旨在提高CAR-T产品的安全性、对抗肿瘤异质性以及提高其扩增和浸润肿瘤的能力。

细胞疗法免疫疗法临床1期临床2期ASH会议

2025-12-11

·同写意

易慕峰生物In Vivo体内生成CAR-T产品IMV101亮相丨会员动态

100 项与靶向CLDN18.2的嵌合抗原受体修饰的自体T细胞（易慕峰）相关的药物交易

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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
CLDN18.2阳性胃食管交界处腺癌	临床3期	中国	苏州易慕峰生物科技有限公司	2025-08-06
CLDN18.2阳性胃癌	临床3期	中国	苏州易慕峰生物科技有限公司	2025-08-06
局部晚期不可切除的胃腺癌	临床3期	中国	苏州易慕峰生物科技有限公司	2025-08-06
CLDN18.2阳性胃肠道肿瘤	临床2期	中国	苏州易慕峰生物科技有限公司	2023-08-22
CLDN18.2阳性胰腺癌	临床2期	中国	苏州易慕峰生物科技有限公司	2023-08-22
转移性消化系统癌	临床1期	中国	苏州易慕峰生物科技有限公司	2023-09-07
晚期胃癌	临床1期	中国	苏州易慕峰生物科技有限公司	2022-08-08
晚期恶性实体瘤	临床1期	中国	苏州易慕峰生物科技有限公司	2022-08-08
胃食管交界处腺癌	临床1期	中国	苏州易慕峰生物科技有限公司	2022-08-08
卵巢上皮癌	临床1期	中国	苏州易慕峰生物科技有限公司	2022-08-08

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临床结果

适应症

分期

评价

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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


NCT05472857 (ASCO2024) 人工标引	临床1期	CLDN18.2阳性实体瘤 \| CLDN18.2阳性胃癌 CLDN18.2 Positive	3	IMC002 1 million CAR-T cells/kg	鹹蓋壓願願遞範膚醖淵(獵遞蓋範構積範願繭壓) = None 製鏇鹽鑰選窪築蓋糧鹽 (壓鑰窪壓蓋選遞憲廠夢 ) 更多	积极	2024-05-24
				IMC002 3 million CAR-T cells/kg