Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics)(Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics))

概要

基本信息

药物类型

肿瘤浸润淋巴细胞

别名

TILS Shanghai Gencells Therapeutics、Tumor infiltrating lymphocytes Shanghai Gencells Therapeutics

靶点-

作用方式-

作用机制

免疫细胞毒性、T淋巴细胞替代物

治疗领域

肿瘤泌尿生殖系统疾病神经系统疾病+ [2]

在研适应症

非在研适应症

原研机构

在研机构

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-

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关联

8

项与 Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics) 相关的临床试验

NCT05087745

/ Recruiting早期临床1期

A Clinical Study on Tumor Infiltrating Lymphocytes for the Treatment of Advanced Solid Tumors

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

开始日期2021-12-10

申办/合作机构

上海君赛生物科技有限公司

[+1]

NCT05142475

/ Recruiting早期临床1期

A Clinical Study on TIL for the Treatment of Advanced Breast Cancer

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy (GC 101 TIL) in patients with advanced breast cancer. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

开始日期2021-11-19

申办/合作机构

上海君赛生物科技有限公司

[+1]

NCT05098184

/ Recruiting早期临床1期

A Clinical Study on TIL for the Treatment of Advanced Melanoma

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

开始日期2021-09-26

申办/合作机构

上海君赛生物科技有限公司

[+1]

100 项与 Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics) 相关的临床结果

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100 项与 Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics) 相关的转化医学

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100 项与 Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics) 相关的专利（医药）

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1

项与 Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics) 相关的文献（医药）

BMC Medicine

IL-2-free tumor-infiltrating lymphocyte therapy with PD-1 blockade demonstrates potent efficacy in advanced gynecologic cancer

Article

作者: Liu, Chunhong ; Li, Caixia ; Yang, Weihong ; Lu, Zhen ; Wang, Rui ; Zhu, Jihui ; Guo, Jing ; Wang, Chunyan ; Ge, Yao ; Cheng, Zhongping ; Bast, Robert C ; Ding, Jinye ; Jin, Huajun ; Chen, Rong ; Zhao, Binghui ; Luo, Ning ; Ai, Guihai ; Huang, Wei ; Liu, Shupeng ; Wu, Yuliang ; Shi, Weihui

AbstractBackgroundTumor-infiltrating lymphocyte (TIL) therapy has been restricted by intensive lymphodepletion and high-dose intravenous interleukin-2 (IL-2) administration. To address these limitations, we conducted preclinical and clinical studies to evaluate the safety, antitumor activity, and pharmacokinetics of an innovative modified regimen in patients with advanced gynecologic cancer.MethodsPatient-derived xenografts (PDX) were established from a local recurrent cervical cancer patient. TILs were expanded ex vivo from minced tumors without feeder cells in the modified TIL therapy regimen. Patients underwent low-dose cyclophosphamide lymphodepletion followed by TIL infusion without intravenous IL-2. The primary endpoint was safety; the secondary endpoints included objective response rate, duration of response, and T cell persistence.ResultsIn matched patient-derived xenografts (PDX) models, homologous TILs efficiently reduced tumor size (p < 0.0001) and underwent IL-2 absence in vivo. In the clinical section, all enrolled patients received TIL infusion using a modified TIL therapy regimen successfully with a manageable safety profile. Five (36%, 95% CI 16.3–61.2) out of 14 evaluable patients experienced objective responses, and three complete responses were ongoing at 19.5, 15.4, and 5.2 months, respectively. Responders had longer overall survival (OS) than non-responders (p = 0.036). Infused TILs showed continuous proliferation and long-term persistence in all patients and showed greater proliferation in responders which was indicated by the Morisita overlap index (MOI) of TCR clonotypes between infused TILs and peripheral T cells on day 14 (p = 0.004) and day 30 (p = 0.004). Higher alteration of the CD8+/CD4+ ratio on day 14 indicated a longer OS (p = 0.010).ConclusionsOur modified TIL therapy regimen demonstrated manageable safety, and TILs could survive and proliferate without IL-2 intravenous administration, showing potent efficacy in patients with advanced gynecologic cancer.Trial registrationNCT04766320, Jan 04, 2021.

100 项与 Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics) 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
晚期乳腺癌	临床1期	中国	上海君赛生物科技有限公司	2021-11-19
肝癌	临床1期	中国	上海君赛生物科技有限公司	2021-09-26
黑色素瘤	临床1期	中国	上海君赛生物科技有限公司	2021-09-26
胃肠道间质瘤	临床1期	中国	上海君赛生物科技有限公司	2021-06-27
脑恶性胶质瘤	临床1期	中国	上海君赛生物科技有限公司	2021-05-06
晚期恶性实体瘤	临床1期	中国	上海君赛生物科技有限公司	2021-04-22
胶质瘤	临床1期	中国	上海君赛生物科技有限公司	2021-04-14
女性生殖器官肿瘤	临床1期	中国	上海君赛生物科技有限公司	2021-01-04

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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


NCT04766320 (Pubmed) 人工标引	临床1期	女性生殖器官肿瘤	14	TIL infusion with modified regimen	(糧簾鏇憲鑰鹽淵醖餘鹹) = In the clinical section, all enrolled patients received TIL infusion using a modified TIL therapy regimen successfully with a manageable safety profile. 選鬱鏇繭窪餘遞製範簾 (蓋鑰齋膚憲醖範願夢願 ) 更多	积极	2024-05-20
SITC2017	N/A	黑色素瘤	-	Tumor Infiltrating Lymphocytes (TIL) (Polystyrene 24-well culture plates)	夢構簾構膚鹽襯獵膚願(鏇簾夢鹹鏇憲願獵積觸) = 觸淵願齋壓齋選襯鏇餘襯選衊衊齋廠鬱鬱衊積 (鏇醖網築鑰襯膚獵鹹築, 14) 更多	积极	2017-11-07
SITC2017	N/A	黑色素瘤	-	Tumor Infiltrating Lymphocytes (TIL) (Gas-permeable (G-REX) 24-well culture plates)	夢構簾構膚鹽襯獵膚願(鏇簾夢鹹鏇憲願獵積觸) = 築選範襯餘鑰餘醖鹽積襯選衊衊齋廠鬱鬱衊積 (鏇醖網築鑰襯膚獵鹹築, 8) 更多	积极	2017-11-07