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更新于：2025-07-06
IMMUXELL BIOTECH LTD.
更新于：2025-07-06
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NCT06898385
A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation
NCT06487377
A Clinical Study of IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
CTR20251024
IX001 TCR-T注射液治疗KRAS G12V突变的晚期胰腺癌患者的I期临床研究
100 项与 上海镔铁生物科技有限责任公司 相关的临床结果
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2024-10-15ANALYTICAL CHEMISTRY
DEPICT-seq: Single-Cell Transcriptomic Analysis of Rare Cell Subsets Isolated via Nucleic Acid Cytometry
Article
作者: Zhang, Jingwei ; Jiang, Xiaochun ; Liu, Tiemin ; Bao, Kaixuan ; Hu, Hong-min
The ability to dive deep into specific rare cell populations is critical for understanding tissue physiology and pathology across various biological domains. As single-cell RNA-seq flourishes, many newly discovered cell subtypes are defined by their transcriptomic markers. However, our ability to retrieve and analyze cells based on their nucleic acid markers remains underdeveloped. Here, we present Double Emulsion PCR-Initiated Cell sorting and Transcriptomic Sequencing (DEPICT-seq), a high-throughput droplet nucleic acid cytometry method that integrates batch cell fixation for cellular information preservation, double emulsion digital PCR-based cell sorting to target nucleic acid markers of interest, and in-depth full-length transcriptomic analyses at single-cell resolution. We utilize DEPICT-seq to isolate and characterize T cell receptor (TCR)-engineered T cells within a mixed population and also demonstrate a variation of the workflow by incorporating an RNase H-dependent PCR step to enrich full-length TCR sequences for paired single-cell TCR sequencing and transcriptomic profiling.
CLINICAL CANCER RESEARCH
IND-Enabling Studies for a TCR-T targeting a pancreatic cancer G12V KRAS mutation
Article
作者: Zhu, Daojun ; Yao, Anlong ; Yu, Guangjie ; Shen, Rongxi ; Qiu, Shuyi ; Wang, Sizhen ; Ouyang, Yonghao ; Gan, Chi ; Jiang, Xiaochun ; Zhang, Xiaohui ; Li, Min ; Wang, Xinbo ; Huang, Lei ; Wei, Ran ; Hu, Hong-Ming ; Sun, Zhufeng ; Chen, Yimin ; Chen, Ling ; Yang, Jiongming ; Wu, Dou ; Xiao, Yi ; Dai, Yanzhenzi
Abstract:
Purpose: To develop adoptive T-cell therapy with genetically engineered TCR (TCR-T) that recognizes the KRAS G12V mutation, we performed an IND-enabling preclinical study of a new TCR (051). This TCR was isolated from a pancreatic ductal adenocarcinoma (PDAC) patient carrying the KRAS G12V mutation that could be presented by the HLA-A*11:01 allele, the most common allele of the Chinese population. Experimental Design: In vitro experiments using T cells from health donors transduced with a retroviral vector expressing 051 TCR were performed to determine the TCR specificity and functionality. The tumor reactivity strictly depended on the expression of the G12V mutation and HLA-A*11:01 molecules. The alanine scan experiment did not detect potential “off-target” cross-reactivity against the human genome. Good Laboratory Practice (GLP) studies are carried out to assess the antitumor efficacy, persistence, safety, and toxicities of adoptively transferred human 051 TCR-T cells (IX001) in immunodeficient mice bearing human pancreatic cancer xenografts. Results: After T-cell infusion, a potent antitumor effect was observed with or without IL-2 administration. The analysis of TCR gene integration in host T cells by retrovirus indicated a low risk of developing secondary malignancy. There was no evidence of TCR-T-related toxicity and genotoxicity induced by the retroviral vector. Conclusions: IX001 was safe and highly efficacious in a pancreatic cancer CDX model. Our data support further clinical development of IX001 for HLA-A*11:01 patients with the G12V KRAS mutation.
100 项与 上海镔铁生物科技有限责任公司 相关的药物交易
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100 项与 上海镔铁生物科技有限责任公司 相关的转化医学
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