主要研究目的评估SCG101治疗乙型肝炎病毒相关肝细胞癌（HBV-HCC）的安全性、耐受性及剂量限制性毒性（dose-limiting toxicity, DLT），确定最大耐受剂量（MTD）或II期推荐剂量（RP2D）。次要研究目的评估SCG101治疗HBV-HCC的初步临床疗效；评估SCG101的抗病毒活性，以及对肝功能和血清肿瘤标志物甲胎蛋白（AFP）水平的影响；评估SCG101静脉输注前、后药代动力学特征（病毒载体拷贝数（VCN））的变化。探索性目的评估SCG101静脉输注前、后外周血SCG101浓度的变化；评估SCG101静脉输注前、后相关细胞因子的变化；评估SCG101静脉输注前、后免疫特征的变化。

开始日期2022-11-09

申办/合作机构

星汉德生物医药（大连）有限公司

NCT05417932

/ Recruiting临床1/2期

A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma

开始日期2022-10-26

申办/合作机构

SCG Cell Therapy Pte. Ltd.初创企业

NCT06617000

/ Recruiting临床1期

A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.

开始日期2022-10-25

申办/合作机构

SCG Cell Therapy Pte. Ltd.初创企业

100 项与 SCG101自体T细胞相关的临床结果

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100 项与 SCG101自体T细胞相关的转化医学

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100 项与 SCG101自体T细胞相关的专利（医药）

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项与 SCG101自体T细胞相关的文献（医药）

2024-10-01·Clinical and Molecular Hepatology

Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting

Article

作者: Jin, Tao ; Du, Shunda ; Wan, Xueshuai ; Zhang, Ke ; Pang, Yong ; Wang, Xiaorui ; Wu, Yu ; Ma, Christy ; Wu, Xiang'an ; Li, Qi ; Liu, Fang ; Wisskirchen, Karin ; Yang, Lu ; Protzer, Ulrike

Background/Aims: Hepatitis B virus (HBV)-DNA integration in HBV-related hepatocellular carcinoma (HBV-HCC) can be targeted by HBV-specific T cells. SCG101 is an autologous, HBV-specific T-cell product expressing a T-cell receptor (TCR) after lentiviral transduction recognizing the envelope-derived peptide (S20-28) on HLA-A2. We here validated its safety and efficacy preclinically and applied it to an HBV-related HCC patient (NCT05339321).Methods: Good Manufacturing Practice-grade manufactured cells were assessed for off-target reactivity and functionality against hepatoma cells. Subsequently, a patient with advanced HBV-HCC (Child-Pugh class A, Barcelona Clinic Liver Cancer stage B, Eastern Cooperative Oncology Group performance status 0, hepatitis B e antigen-, serum hepatitis B surface antigen [HBsAg]+, HBsAg+ hepatocytes 10%) received 7.9×107 cells/kg after lymphodepletion. Safety, T-cell persistence, and antiviral and antitumor efficacy were evaluated.Results: SCG101, produced at high numbers in a closed-bag system, showed HBV-specific functionality against HBV-HCC cells in vitro and in vivo. Clinically, treatment was well tolerated, and all adverse events, including transient hepatic damage, were reversible. On day 3, ALT levels increased to 1,404 U/L, and concurrently, serum HBsAg started decreasing by 3.84 log10 and remained <1 IU/mL for over six months. HBsAg-expressing hepatocytes in liver biopsies were undetectable after 73 days. The patient achieved a partial response according to modified RECIST with a >70% reduction in target lesion size. Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient’s blood.Conclusions: SCG101 T-cell therapy showed encouraging efficacy and safety in preclinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg+ cells and achieve sustained tumor control after single dosing.

2023-08-01·Hepatology international

Messenger RNA electroporated hepatitis B virus (HBV) antigen-specific T cell receptor (TCR) redirected T cell therapy is well-tolerated in patients with recurrent HBV-related hepatocellular carcinoma post-liver transplantation: results from a phase I trial.

Article

作者: Yang, Li ; Yang, Fan ; Chen, Wenjie ; Du, Cong ; Wai, Lu-En ; Cheng, Jintao ; Chen, Xiaoyan ; Zheng, Xiaofang ; Chen, Wanxin ; Lu, Jianxi ; Koh, Sarene ; Wang, Tingting ; Wong, Regina Wanju ; Zhang, Qi ; Chen, Yunhao ; Li, Panlong

BACKGROUND AND AIMSLiver transplantation (LT) is the primary curative option for cirrhotic patients with early-stage hepatocellular carcinoma (HCC). However, tumor recurrence occurs in 15-20% of cases with unfavorable prognosis. We have developed a library of T cell receptors (TCRs) specific for different hepatitis B virus (HBV) antigens, restricted by different molecules of human leucocyte antigen (HLA)-class I, to redirect T cells against HBV antigens (Banu in Sci Rep 4:4166, 2014). We further demonstrated that these transiently functional T cells specific for HBV obtained through messenger RNA (mRNA) electroporation can eliminate HCC cells expressing HBV antigens in vitro and in vivo (Kah in J Clin Invest 127:3177-3188, 2017). A phase I clinical trial for patients with HCC recurrence post-liver transplant was conducted to assess the safety, tolerability, and anti-tumor efficacy of transiently functional HBV-TCR T cells. Here, we report the clinical findings with regard to the safety and anti-tumor efficacy of mRNA electroporated HBV-specific TCR-T cells. (ClinicalTrials.gov identifier: NCT02719782).PATIENTS AND METHODSA total of six patients with HBV-positive recurrent HCC post-liver transplant and HLA-matched to TCR targeting hepatitis B surface antigen (HBsAg) or hepatitis B core antigen (HBcAg) (HLA-A*02:01/HBsAg, HLA-A*11:01/HBcAg, HLA-B*58:01/HBsAg or HLA-C*08:01/HBsAg) were enrolled in this study. The primary objective was to assess the safety of short-lived mRNA electroporated HBV-TCR T cells based on the incidence and severity of the adverse event (AE) graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. The secondary objective was to determine the effectiveness of HBV-TCR T cells as per RECIST 1.1 criteria. Patients were followed up for survival for 2 years post-end of treatment.RESULTSThe median age of the six patients was 35.5 years (range: 28-47). The median number of HBV-TCR T cell infusions administered was 6.5 (range: 4-12). The treatment-related AE included grade 1 pyrexia. This study reported no cytokine release syndrome nor neurotoxicity. One patient remained alive and five were deceased at the time of the data cutoff (30 April 2020).CONCLUSIONThis study has demonstrated that multiple infusions of mRNA electroporated HBV-specific TCR T cells were well-tolerated in patients with HBV-positive recurrent HCC post-liver transplant.

2021-12-01·Hepatology International2区 · 医学

Immunotherapy of HBV-related advanced hepatocellular carcinoma with short-term HBV-specific TCR expressed T cells: results of dose escalation, phase I trial

2区 · 医学

Article

作者: Wu, Juan ; Luan, Junqing ; Fu, Jun-Liang ; Wang, Tingting ; Liu, Limin ; Shi, Ming ; Shi, Lei ; Bertoletti, Antonio ; Zhang, Ji-Yuan ; Wong, Regina Wanju ; Jin, Jiehua ; Tan, Anthony Tanoto ; Li, Yuanyuan ; Xie, Yunbo ; Wang, Si-Yu ; Zhou, Chun-Bao ; Zhao, Jinfang ; Yu, Shuangjie ; Koh, Sarene ; Lu-En, Wai ; Hu, Wei ; Wang, Fu-Sheng ; Shen, Yingjuan ; Meng, Fanping

AbstractBackground & aimsImmunotherapy with hepatitis B virus (HBV)-specific TCR redirected T (HBV-TCR-T) cells in HBV-related hepatocellular carcinoma (HBV-HCC) patients after liver transplantation was reported to be safe and had potential therapeutic efficacy. We aim to investigate the safety of HBV-TCR-T-cell immunotherapy in advanced HBV-HCC patients who had not met the criteria for liver transplantation.MethodsWe enrolled eight patients with advanced HBV-HCC and adoptively transferred short-lived autologous T cells expressing HBV-specific TCR to perform an open-label, phase 1 dose-escalation study (NCT03899415). The primary endpoint was to evaluate the safety of HBV-TCR-T-cell therapy according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03) during the dose-escalation process. The secondary endpoint was to assess the efficacy of HBV-TCR-T-cell therapy by evaluating the anti-tumor responses using RECIST criteria (version 1.1) and the overall survival.ResultsAdverse events were observed in two participants among the 8 patients enrolled. Only one patient experienced a Grade 3 liver-related adverse event after receiving a dose of 1 × 105 HBV-TCR-T cells/kg, then normalized without interventions with immunosuppressive agents. Among the patients, one achieved a partial response lasting for 27.7 months. Importantly, most of the patients exhibited a reduction or stabilization of circulating HBsAg and HBV DNA levels after HBV-TCR-T-cell infusion, indicating the on-target effects.ConclusionsThe adoptive transfer of HBV-TCR-T cells into advanced HBV-HCC patients were generally safe and well-tolerated. Observations of clinical efficacy support the continued development and eventual application of this treatment strategy in patients with advanced HBV-related HCC.Clinical trials registrationThis study was registered at ClinicalTrials.gov (NCT03899415).

项与 SCG101自体T细胞相关的新闻（医药）

2025-01-08

·生物谷

晚讯｜30亿美元合同不要了？紧跟药明康德，药明生物拟5亿美元出售海外资产，默沙东接盘、子孙三代换血真相，哈佛大学医学院给出回答

1. 30亿美元合同不要了？紧跟药明康德，药明生物拟5亿美元出售海外资产，默沙东接盘药明生物拟以5亿美元将爱尔兰疫苗工厂出售给默沙东，该工厂原为履行与默沙东的30亿美元疫苗生产合同而建。交易预计2025年上半年完成，所得款项将用于营运资金和股份回购。此举引发药明生物股价下跌。 2. 子孙三代换血真相，哈佛大学医学院给出回答哈佛大学医学院研究显示，造血干细胞在抗衰老中具有巨大潜力，年轻干细胞移植可改善老年小鼠健康并延长寿命，老年干细胞则功能衰退。 3. 默沙东佳达修®成为中国境内首个且目前唯一获批、可适用于男性的HPV疫苗默沙东佳达修®成为中国首个获批适用于男性的HPV疫苗，可预防肛门癌和生殖器疣，助力男女共防HPV事业，推动健康中国2030战略实施。 4. 肿瘤缩小超七成，病毒全清，星汉德TCR-T新药IND国内获批，降维打击肺癌、肝癌、宫颈癌等实体瘤星汉德生物全新一代TCR-T细胞疗法SCG142获批新药临床试验，针对HPV感染相关恶性肿瘤，为抗病毒感染相关癌症提供新治疗选择。同时，其另一款TCR-T疗法SCG101对乙肝病毒相关肝细胞癌疗效显著。 5. 血霁生物获得数千万元新投资，推进血小板的细胞治疗和多重应用 2025年1月8日，苏州血霁生物科技有限公司（以下简称“血霁生物”）宣布获得中科康美数千万元资本投资。该笔增资将用于继续推动血霁生物多个血小板相关管线的IND申请和正式临床试验的开展，进一步推进血小板药物递送的第一条管线的临床前工作以及开展血替和美业等业务。 6. 国内6家公司完成新一轮融资，聚焦细胞与基因治疗领域瑞风生物、宜明生物等六家细胞与基因治疗公司获得新一轮融资，用于推动研发和技术创新，具体融资金额、轮次及投资机构各异。本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！

细胞疗法临床申请疫苗免疫疗法基因疗法

2025-01-03

·医药健闻

2025开年重磅：星汉德生物全球首创HPV相关肿瘤全新一代TCR-T获批

美通社消息，1月2日，星汉德生物（SCG）宣布，国家药品监督管理局药品审评中心（NMPA）已批准其全新一代人乳头瘤病毒（HPV）特异性T细胞受体（TCR）工程化T细胞治疗--SCG142的新药临床试验（IND）申请，用于治疗HPV感染相关的恶性肿瘤，包括宫颈癌、口咽癌、头颈癌、阴道癌、外阴癌和阴茎癌等。人乳头瘤病毒（HPV）是可以感染人体的皮肤和黏膜而导致多种恶性肿瘤的病毒，主要通过性接触传播，也可通过母婴垂直传播而感染。全球范围内约5%的癌症由HPV感染所致。以宫颈癌为例，几乎100%的宫颈癌由HPV感染导致，全球宫颈癌每年新发66万例，死亡约35万例，是全球女性最高发的恶性肿瘤之一。同时，HPV导致的男性相关肿瘤在世界范围内也正在快速增长，但缺乏关注和重视。目前，HPV相关晚期肿瘤患者仍然缺乏有效的治疗手段，存在巨大的未能满足的临床需求。星汉德生物开发的SCG142是一款具有显著差异化的“下一代”TCR-T细胞治疗产品，基于星汉德生物全球领先的GianTCRTM独有技术平台，成功筛选获得超高亲和力的全天然HPV特异性TCR，并搭配星汉德生物自主研发的新型嵌合开关受体多能T细胞增强模块。这一突破性的创新技术，与传统TCR-T细胞疗法相比具有无可比拟的优势，可使T细胞在克服抑制性肿瘤微环境的同时，进一步增强CD8+和CD4+ TCR-T细胞的增殖和肿瘤杀伤作用，这对于实现实体瘤的突破性疗效至关重要。 2024年5月，在美国巴尔的摩举行的《第27届美国基因与细胞治疗年会》上，星汉德生物以大会口头报告形式公布了SCG142的临床前数据，随即引起行业广泛关注和强烈反响。研究数据表明，新一代SCG142通过嵌合开关受体强化技术，在不依赖于CD8共受体信号的情况下，能有效双重激发CD8+与CD4+ TCR-T细胞，在高度免疫抑制性的肿瘤微环境下，发挥强效的抗肿瘤活性，并促进记忆性T细胞的长期存续，确保免疫细胞疗法持久显著的治疗效果。此外SCG142的高亲和力特性，可以同时识别HPV-16和HPV-52基因型相关宫颈癌、头颈癌等多种HPV病毒相关肿瘤，显著提升患者人群覆盖率。星汉德生物全球研发副总裁 Susanne Wilde博士星汉德生物首席科学官张柯博士表示：SCG142作为全球首款基于嵌合开关受体创新技术的“下一代”细胞治疗产品获批临床，标志着星汉德生物在细胞治疗前沿领域的持续突破与稳步前行。可喜的是，SCG142先后成功获得美国食药监局（FDA）和新加坡卫生科学局（HSA）的I/II期新药临床试验（IND）批准，并迅速同步在中国获批。这一系列重要里程碑标志着SCG142的全球临床试验布局全面提速，为全球范围内HPV相关恶性肿瘤患者点燃了新的希望之光。更加重要的是，SCG142是继SCG101（HBV特异性TCR-T细胞治疗）成为中国首个临床获批治疗肝癌的TCR-T细胞治疗药物后，星汉德生物推出的又一款同步获得美国、中国、新加坡等多国药监部门批准的TCR-T产品。这标志着我们具备了开发多元化TCR-T产品为不同的癌症患者带来全新治疗手段的能力。这背后也正是依托于星汉德生物拥有的全球最顶尖的、也是独一无二的TCR发现平台的强大技术支撑，并为产品的卓越性能奠定了坚实基础。联系美通社 +86-10-5953 9500 info@prnasia.com

细胞疗法临床申请免疫疗法

2025-01-02

·癌度

《癌度早报2025年1月2日》

一、新药快讯 1、国产PD-L1抑制剂塔戈利单抗获批上市 2024年12月31日，国家药品监督管理局官网信息披露，国产靶向PD-L1的免疫治疗药物塔戈利单抗获批上市，用于治疗既往接受过二线及以上化疗失败的复发性或转移性鼻咽癌。基于已经公布的临床试验结果，这款药治疗的应答率为26.5%，疾病控制率为 56.8%，中位无进展生存时间为2.8个月，中位缓解持续时间为12.4个月，中位总生存时间为16.2个月。塔戈利单抗为国内批准的第8款PD-L1单抗药。 2、新一代靶向药HL-085启动临床试验，招募肠癌患者 HL-085是一款靶向MEK1和MEK2的抑制剂，这款药终于开启临床试验。招募入组的患者为经过标准治疗失败且存在BRAF基因突变的结直肠癌患者，用药方案为HL-085联合维莫非尼。具体的治疗机制应该是同时阻断MEK和BRAF，以增强抗肿瘤的治疗效果。 3、美国FDA加速批准泽妥珠单抗用于治疗特定胰腺癌近日，美国FDA加速批准了泽妥珠单抗上市，适应症为NRG1基因融合的晚期、不可切除或转移性胰腺癌。妥珠单抗是一种双特异性抗体药物，可以与HER2和HER3结合，阻断癌症信号的传递。相应的临床试验证据表面，这款药治疗NRG1基因融合的胰腺癌，治疗应答率为40%，这凸显了胰腺癌患者有必要做特定基因检测，以尝试使用这款药物。二、新药快讯 1、北京协和医院完成全球首个TCR-T治疗，28天肿瘤所想84% 近日，北京协和医院的杜顺达教授团队在《临床和分子肝病学》发表了一项研究，全球首例乙肝特异性T细胞疗法成功应用于晚期肝癌患者，实现了肿瘤显著缩小和乙肝病毒完全清除，为乙肝肝癌的治疗带来了革命性的希望。这款名为SCG101的治疗方案让患者病灶缩小超过74.5%，近7个月病情无进展。治疗过程中短暂出现肝功能受损等不良反应，但所有不良反应均可逆，且患者的耐受性良好。

上市批准细胞疗法加速审批免疫疗法

100 项与 SCG101自体T细胞相关的药物交易

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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
乙型肝炎	临床2期	美国	SCG Cell Therapy Pte. Ltd.初创企业	2022-10-26
乙型肝炎	临床2期	新加坡	SCG Cell Therapy Pte. Ltd.初创企业	2022-10-26
乙型肝炎	临床2期	中国香港	SCG Cell Therapy Pte. Ltd.初创企业	2022-10-26
乙型肝炎病毒相关肝细胞癌	临床2期	中国香港	SCG Cell Therapy Pte. Ltd.初创企业	2022-10-26
乙型肝炎病毒相关肝细胞癌	临床2期	新加坡	SCG Cell Therapy Pte. Ltd.初创企业	2022-10-26
乙型肝炎病毒相关肝细胞癌	临床2期	美国	SCG Cell Therapy Pte. Ltd.初创企业	2022-10-26
肝内胆管癌	临床申请批准	中国	星汉德生物医药（大连）有限公司	2023-11-23

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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


PRNewswire 人工标引	N/A	肝癌	6	SCG101	(簾築膚醖觸網醖鑰憲餘) = 範襯範醖餘繭淵鬱鹽獵鏇艱糧簾築淵襯夢衊鑰 (鬱壓顧醖構積糧膚窪範 ) 更多	积极	2024-06-07
NCT06617000 (PRNewswire) 人工标引	临床1期	晚期肝细胞癌	-	SCG101	(淵襯鬱壓遞醖積鑰壓憲) = generally well tolerated with no cases of serious adverse events or immune effector cell-associated neurotoxicity syndrome. The most common treatment-related adverse events were transient liver enzymes evaluation, cytokine release syndrome (CRS), and fever 壓衊窪鑰艱襯壓鹽鏇齋 (醖積願繭蓋遞醖積觸壓 )	积极	2023-11-13
NCT06617000 (PRNewswire) 人工标引	临床1期	晚期肝细胞癌	-	SCG101 (HBsAg reduction >1 log)		积极	2023-11-13