预约演示
更新于：2026-01-17
IMC-001(Immunofoco Biotech)
更新于：2026-01-17
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)临床1期 |
特殊审评孤儿药 (美国) |
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关联
3
项与 IMC-001(Immunofoco Biotech) 相关的临床试验NCT05028933
Autologous T Cells Modified by Chimeric Antigen Receptor Targeting EpCAM for Clinical Research on Advanced Digestive System Malignancies
NCT02915445
T Cells Armed With Chimeric Antigen Receptor Recognizing EpCAM for Patients With Advanced Solid Tumors
CTR20260059
一项评价IMC001在上皮性晚期实体瘤受试者中的安全性及疗效的I/IIa期临床试验
100 项与 IMC-001(Immunofoco Biotech) 相关的临床结果
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100 项与 IMC-001(Immunofoco Biotech) 相关的转化医学
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100 项与 IMC-001(Immunofoco Biotech) 相关的专利（医药）
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4
项与 IMC-001(Immunofoco Biotech) 相关的文献（医药）2025-11-01MOLECULAR THERAPY
Preclinical development and a phase 1 trial of IMC001, an EpCAM-targeted CAR-T cell therapy, in patients with advanced gastric cancer
Article
作者: Zhang, Shuangshuang ; Ge, Jingyu ; Yin, Weiwei ; Sun, Minmin ; Fang, Weijia ; Hao, Ruidong ; Luo, Tianhang ; Zheng, Rui ; Lu, Zhengmao
Autologous EpCAM-targeted CAR-T cell therapy (IMC001) was developed for advanced gastric cancer (GC). This study evaluated the specificity, efficacy, and safety of IMC001 in preclinical models and a phase 1 dose-escalation/expansion trial in patients who had failed at least two lines of therapy. IMC001 specifically recognized EpCAM and exhibited potent anti-tumor activity in EpCAM+ tumor cells, xenograft models, and patient-derived organoids. From August 2021 to May 2023, 12 advanced GC patients received IMC001. All patients experienced grade 3 or 4 treatment-related adverse events, mainly lymphopenia related to lymphodepletion, with no treatment-related deaths. Five patients experienced cytokine release syndrome (n = 3, grade 3-4) and two patients experienced immune-related hepatitis (n = 1, grade 3 in middle-dose group; n = 1, grade 4 in high-dose group). Partial responses were observed in 33.3% (1/3) of low-dose patients and 40% (2/5) of middle-dose patients, achieving an objective response rate of 30% and a disease control rate of 70%. Median progression-free survival and overall survival were 4.5 and 8.4 months, respectively. One patient underwent conversion surgery at week 27 and remains alive 31.5 months post-infusion. These findings demonstrate an acceptable safety profile and promising efficacy of IMC001 in advanced GC, supporting further clinical development for refractory GC patients.
2021-11-01Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学
Rapamycin Pretreatment Rescues the Bone Marrow AML Cell Elimination Capacity of CAR-T Cells
1区 · 医学
Article
作者: Fu, Binqing ; Wei, Haiming ; Nian, Zhigang ; Du, Xianghui ; Sun, Rui ; Dou, Yingchao ; Tian, Zhigang ; Zheng, Xiaohu ; Zhou, Li
Abstract:
Purpose::
Ongoing clinical trials show limited efficacy for Chimeric antigen receptor (CAR) T treatment for acute myeloid leukemia (AML). The aim of this study was to identify potential causes of the reported limited efficacy from CAR-T therapies against AML.
Experimental Design::
We generated CAR-T cells targeting Epithelial cell adhesion molecule (EpCAM) and evaluated their killing activity against AML cells. We examined the impacts of modulating mTORC1 and mTORC2 signaling in CAR-T cells in terms of CXCR4 levels. We examined the effects of a rapamycin pretreatment of EpCAM CAR-T cells (during ex vivo expansion) and assessed the in vivo antitumor efficacy of rapamycin-pretreated EpCAM CAR-T cells (including CXCR4 knockdown cells) and CD33 CAR-T cells in leukemia xenograft mouse models.
Results::
EpCAM CAR-T exhibited killing activity against AML cells but failed to eliminate AML cells in bone marrow. Subsequent investigations revealed that aberrantly activated mTORC1 signaling in CAR-T cells results in decreased bone marrow infiltration and decreased the levels of the rapamycin target CXCR4. Attenuating mTORC1 activity with the rapamycin pretreatment increased the capacity of CAR-T cells to infiltrate bone marrow and enhanced the extent of bone marrow AML cell elimination in leukemia xenograft mouse models. CXCR4 knockdown experiments showed that CXCR4 contributes to the enhanced bone marrow infiltration capacity of EpCAM CAR-T cells and the observed reduction in bone marrow AML cells.
Conclusions::
Our study reveals a potential cause for the limited efficacy of CAR-T reported from current AML clinical trials and illustrates an easy-to-implement pretreatment strategy, which enhances the anti-AML efficacy of CAR-T cells.See related commentary by Maiti and Daver, p. 5739
2020-01-01Oncoimmunology2区 · 医学
Potential lung attack and lethality generated by EpCAM-specific CAR-T cells in immunocompetent mouse models
2区 · 医学
ArticleOA
作者: Alexander, Peter B. ; Chen, Yue ; Li, Dan ; Wang, Yongsheng ; Li, Xiaoyu ; Zhang, Benxia ; Qin, Diyuan ; Liao, Xuelian ; Li, Qi-Jing
The tumoricidal efficiency of human CAR-T cells is generally evaluated using immune-deficient mouse models; however, due to their immune-incompetency and the species-specific reactivity of a target antigen, these models are problematic to imitate CAR-T-induced adverse effects in the clinic. Epithelial cell adhesion molecule (EpCAM) is a tumor-associated antigen overtly presented on the cell surface of various carcinomas, making it an attractive target for CAR-T therapy. Here, we developed an anti-mouse EpCAM CAR to evaluate its safety and efficacy in immunocompetent mouse models. As previously reported for their human equivalents, murine EpCAM CAR-T cells exhibit promising anti-tumor efficacy in vitro and in vivo. However, after CAR-T infusion, various dose-depended toxicities including body weight loss, cytokine-release syndrome (CRS), and death were observed in both tumor-bearing and tumor-free mice. Pathological examination revealed unexpected and severe pulmonary immunopathology due to basal EpCAM expression in normal lung. While our study validates EpCAM CAR-T's potent anti-tumor efficacy, it also reveals that EpCAM CAR-T cells used for the treatment of solid tumors may cause lethal toxicity and should, therefore, be evaluated in patients with caution.
51
项与 IMC-001(Immunofoco Biotech) 相关的新闻（医药）2026-01-13
·医切
临床1期抗体药物偶联物临床2期申请上市
2026-01-12
·同写意
细胞疗法免疫疗法ASCO会议临床结果临床3期
2025-12-11
·同写意
100 项与 IMC-001(Immunofoco Biotech) 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 |
|---|---|---|---|---|
| 胆道癌 | 临床1期 | 中国 | 2026-01-12 | |
| 结直肠癌 | 临床1期 | 中国 | 2026-01-12 | |
| 胃肠胰神经内分泌肿瘤 | 临床1期 | 中国 | 2026-01-12 | |
| 胃食管交界处腺癌 | 临床1期 | 中国 | 2026-01-12 | |
| 卵巢癌 | 临床1期 | 中国 | 2026-01-12 | |
| 胃癌 | 临床1期 | 中国 | 2026-01-12 | |
| 三阴性乳腺癌 | 临床1期 | 中国 | 2026-01-12 | |
| 晚期结直肠腺癌 | 临床1期 | 中国 | 2021-09-30 | |
| 晚期胃癌 | 临床1期 | 中国 | 2021-09-30 | |
| 晚期肝细胞癌 | 临床1期 | 中国 | 2021-09-30 |
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