Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics)(Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics))

概要

基本信息

药物类型

T细胞疗法

别名-

靶点-

作用方式-

作用机制-

治疗领域

肿瘤口颌疾病耳鼻咽喉疾病+ [1]

在研适应症-

非在研适应症

晚期鼻咽癌鼻咽癌

原研机构

Tessa Therapeutics Ltd

在研机构-

非在研机构

Tessa Therapeutics Ltd

权益机构-

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

7

项与 Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics) 相关的临床试验

NCT02287311

/ Active, not recruiting临床1期IIT

ADMINISTRATION OF MOST CLOSELY MATCHED THIRD PARTY RAPIDLY GENERATED LMP, BARF1 and EBNA1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES TO PATIENTS WITH EBV-POSITIVE LYMPHOMA AND OTHER EBV-POSITIVE MALIGNANCIES

The subject has a type of cancer or lymph gland disease associated with a virus called Epstein Barr Virus (EBV), which has come back, is at risk of coming back, or has not gone away after standard treatments. This research study uses special immune system cells called LMP, BARF-1 and EBNA1- specific cytotoxic T lymphocytes (MABEL CTLs).
Some patients with Lymphoma (such as Hodgkin (HD) or non-Hodgkin Lymphoma (NHL)), T/NK-lymphoproliferative disease, or CAEBV, or solid tumors such as nasopharyngeal carcinoma (NPC), smooth muscle tumors, and leiomyosarcomas show signs of a virus called EBV before or at the time of their diagnosis. EBV causes mononucleosis or glandular fever ("mono" or the "kissing disease"). EBV is found in the cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells (in CAEBV) infected by EBV are able to hide from the body's immune system and escape destruction. EBV is also found in the majority of NPC and smooth muscle tumors, and some leiomyosarcomas. We want to see if special white blood cells (MABEL CTLs) that have been trained to kill EBV infected cells can survive in your blood and affect the tumor.
In previous studies, EBV CTLs were generated from the blood of the patient, which was often difficult if the patient had recently received chemotherapy. Also, it took up to 1-2 months to make the cells, which is not practical when a patient needs more urgent treatment. To address these issues, the MABEL CTLs were made in the lab in a simpler, faster, and safer way. The MABEL CTLs will still see LMP proteins but also two other EBV proteins called EBNA-1 and BARF. To ensure these cells are available for use in patients in urgent clinical need, we have generated MABEL CTLs from the blood of healthy donors and created a bank of these cells, which are frozen until ready for use. We have previously successfully used frozen T cells from healthy donors to treat EBV lymphoma and virus infections and we now have improved our production method to make it faster.
In this study, we want to find out if we can use banked MABEL CTLs to treat HD, NHL, T/NK-lymphoproliferative disease, CAEBV, NPC, smooth muscle tumors or leiomyosarcoma. We will search the bank to find a MABEL CTL line that is a partial match with the subject.
MABEL CTLs are investigational and not approved by the Food and Drug Administration.

开始日期2015-02-01

申办/合作机构

Baylor College of Medicine

[+2]

NCT02578641

/ Completed临床3期

A Multicentre, Randomized, Open-Label, Phase III Clinical Trial Of Gemcitabine And Carboplatin Followed By Epstein-Barr Virus-Specific Autologous Cytotoxic T Lymphocytes Versus Gemcitabine And Carboplatin As First Line Treatment For Advanced Nasopharyngeal Carcinoma(NPC) Patients

This study is a multi-center, randomized, open label, Phase III clinical trial for advanced Nasopharyngeal Carcinoma(NPC) Patients.
Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's cytotoxic T cells (CTL) that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T cells may kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3 T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 30 hospital centers across Asia and the United States.
This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38 patients at the National Cancer Centre, Singapore. This trial produced the best published 2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with advanced NPC who received autologous EBV-specific CTL. Kindly see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled "Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or Locally Recurrent Nasopharyngeal Carcinoma".

开始日期2014-07-01

申办/合作机构

Tessa Therapeutics Ltd

NCT00078546

/ Completed临床1期IIT

Administration of EBV-Specific Cytotoxic T Lymphocytes Following CD45 Antibody to Patients With EBV Positive Nasopharyngeal Carcinoma

To determine the safety of the combination of CD45 monoclonal antibody (Mab) followed by intravenous injection of EBV specific CTL in patients with nasopharyngeal cancer.
To compare the expansion, persistence and anti-tumor effects of the EBV specific CTL given after CD45 Mab administration with that observed in our first study.
To obtain preliminary information on the safety and response to an extended dosage regimen of EBV-specific CTL in patients, who have stable disease or a partial response after the initial dose of EBV-specific CTL.

开始日期2003-09-01

申办/合作机构

Baylor College of Medicine

[+2]

100 项与 Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics) 相关的临床结果

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100 项与 Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics) 相关的转化医学

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100 项与 Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics) 相关的专利（医药）

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11

项与 Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics) 相关的文献（医药）

2024-12-01·ANNALS OF ONCOLOGY

Gemcitabine, carboplatin, and Epstein–Barr virus-specific autologous cytotoxic T lymphocytes for recurrent or metastatic nasopharyngeal carcinoma: VANCE, an international randomized phase III trial

Article

作者: Hasbullah, H.H. ; Wirasorn, K ; Lulla, P. ; Sirachainan, E ; Brenner, M.K. ; Samol, J. ; Horak, I ; Ding, C. ; Ang, M K ; Algazi, A ; Ho, G F ; Wang, H.-M. ; Liu, Y C ; Toh, H C ; Ho, K F ; Myo, A. ; Toh, H.C. ; Wang, W.-W. ; Yang, M-H ; Wirasorn, K. ; Lertbutsayanukul, C. ; Ho, G.F. ; Ho, K.F. ; Wirth, L J ; Low, S.H.J. ; Tan, S H ; Tho, L M ; Nadler, E ; Low, S H J ; Wang, H-M ; Ding, C ; Colevas, A.D. ; Hong, R.-L. ; Ang, S F ; Nadler, E. ; Chitapanarux, I. ; Chitapanarux, I ; Brenner, M K ; Tho, L.M. ; Tan, S.H. ; Ang, S.F. ; Hsieh, C Y ; Lulla, P ; Liu, Y.C. ; Myo, A ; Ang, M.K. ; Ong, W S ; Hsieh, C.Y. ; Lertbutsayanukul, C ; Sirachainan, E. ; Yang, M.-H. ; Colevas, A D ; Samol, J ; Hong, R-L ; Wang, W-W ; Wirth, L.J. ; Ong, W.S. ; Horak, I. ; Algazi, A. ; Hasbullah, H H

BACKGROUND:

Epstein-Barr virus-specific cytotoxic T lymphocyte (EBV-CTL) is an autologous adoptive T-cell immunotherapy generated from the blood of individuals and manufactured without genetic modification. In a previous phase II trial of locally recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) patients, first-line gemcitabine and carboplatin (GC) and EBV-CTL combination demonstrated objective antitumor EBV-CTL activity and a favorable safety profile. The present study explored whether this combined first-line chemo-immunotherapy strategy would produce superior clinical efficacy and better quality of life compared with conventional chemotherapy treatment.

PATIENTS AND METHODS:

This multicenter, randomized, phase III trial evaluated the efficacy and safety of GC followed by EBV-CTL versus GC alone as first-line treatment of R/M NPC patients. Thirty clinical sites in Singapore, Malaysia, Taiwan, Thailand, and the USA were included. Subjects were randomized to first-line GC (four cycles) and EBV-CTL (six cycles) or GC (six cycles) in a 1 : 1 ratio. The primary outcome was overall survival (OS) and secondary outcomes included progression-free survival, objective response rate, clinical benefit rate, quality of life, and safety.

CLINICALTRIALS:

gov identifier: NCT02578641.

RESULTS:

A total of 330 subjects with NPC were enrolled. Most subjects in both treatment arms received four or more cycles of chemotherapy and most subjects in the GC + EBV-CTL group received two or more infusions of EBV-CTL. The central Good Manufacturing Practices (GMP) facility produced sufficient EBV-CTL for 94% of GC + EBV-CTL subjects. The median OS was 25.0 months in the GC + EBV-CTL group and 24.9 months in the GC group (hazard ratio = 1.19; 95% confidence interval 0.91-1.56; P = 0.194). Only one subject experienced a grade 2 serious adverse event related to EBV-CTL.

CONCLUSIONS:

GC + EBV-CTL in subjects with R/M NPC demonstrated a favorable safety profile but no overall improvement in OS versus chemotherapy. This is the largest adoptive T-cell therapy trial reported in solid tumors to date.

2022-08-01·Zhongguo shi yan xue ye xue za zhi

[Clinical Analysis of Post-Transplant Lymphoproliferative Disorder after Hematopoietic Stem Cell Transplantation in Severe Aplastic Anemia Patients].

Article

作者: Ding, Li ; Yan, Hong-Min ; Wang, Heng-Xiang ; Xue, Mei ; Han, Dong-Mei ; Zhu, Ling ; Li, Sheng ; Liu, Jing ; Zheng, Xiao-Li

OBJECTIVE:

To analyze the clinical characteristics of SAA patients with post-transplantation lymphoproliferative disease (PTLD) after allogeneic hematopoietic stem cell transplantation, and to improve diagnosis and treatment of PTLD.

METHODS:

The clinical data of 192 patients with SAA patients who underwent HSCT in a single center from September 2010 to September 2017 were analyzed retrospectively. All patients were received antithymocyte globulin（ATG） conditioning regimen and mesenchymal stem cell(MSC) infusion.

RESULTS:

Among 192 cases, PTLD occurred in 14 cases, the incidence was 7.29％， 9 of them were diagnosed by pathology， and 5 were diagnosed clinically. EBV infection occurred with a median time of 72（35-168） days, Viral load higher than 1×10⁴ copies/ml occured in all PTLD patients. The incidence of probable PTLD in patients ≤12 years old and ＞12 years old was 11.11%, 2.38%, respectively (P<0.01）. Univariate and multivariate analysis that the EBV infection, patients age≤12 years old, HLA-mismatch in URD-HSCT, grade II to IV aGVHD were the independent risk factors for PTLD. All PTLD patients were treated with rituximab(RTX) when EBV-DNA load higher than 1×10⁴ copies/ml, or reducted the use of immunosuppression(RIS), patients with poor therapeutic effect were treated combined with EBV-specific CTLs(EBV-CTL) and chemotherapy. All patients were treated effectively, and the total effective rate was 100％. The median follow-up time was 65(62-115) months, and the overall survival rate was 92.85%. One patients died of cerebral hemorrhage, 7 months after PTLD curred.

CONCLUSION:

The incidence of PTLD after HSCT with SAA who used ATG and MSC in conditioning regimen closely relates to EBV infection, age of patients≤12 years, HLA-mismatch in URD-HSCT, grade II to IV GVHD. Rituximab combined with RIS may reduce the incidence of PTLD, combined EBV-CTL and chemotherapy may be the useful and most important treatment for PTLD.

2021-12-01·Transplant international : official journal of the European Society for Organ Transplantation2区 · 医学

EBV‐specific cytotoxic T lymphocytes for refractory EBV‐associated post‐transplant lymphoproliferative disorder in solid organ transplant recipients: a systematic review

2区 · 医学

Review

作者: Wei, Lin ; Zhang, Jin‐Ming ; Liu, Jing‐Yi ; Sun, Li‐Ying ; Zhan, Hao‐Su

The use of Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs) in adoptive immunotherapy in hematopoietic stem cell transplantation (HSCT) patients with post-transplantation lymphoproliferative disorder (PTLD) has demonstrated safety and effectiveness. EBV-CTLs might also be the effective treatment of refractory PTLD of solid organ transplantation (SOT) recipients. Two independent assessors searched Pubmed, Embase, Cochrane Library, and Web of Science from their inception to November 2020. Eleven studies with 76 patients (42, 55% male) were included. We extracted the data and completed the quality assessments. Most of the studies were from Europe and the USA. Liver and kidney transplantation accounted for most of the transplant types. Thirty-five (46.1%) patients were diagnosed with monomorphic PTLD, and B lymphocyte type was the most common. All the patients received primary treatment for PTLD while it was ineffective. CTLs included autologous EBV-CTLs (15/76, 22%) and HLA-matched third-party EBV-CTLs (61/76, 78%). The response rate for EBV-CTL treatment of refractory PTLD was 66%. Of 50 patients, 36 achieved complete remission and 14 achieved partial remission. EBV-DNA level decreased in 39 patients. Adverse reactions were rare and mild. We conclude that adoptive therapy with EBV-specific CTLs is safe, well-tolerated, and effective in PTLD.

100 项与 Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics) 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
晚期鼻咽癌	临床3期	美国	Tessa Therapeutics Ltd	2014-07-01
晚期鼻咽癌	临床3期	马来西亚	Tessa Therapeutics Ltd	2014-07-01
晚期鼻咽癌	临床3期	新加坡	Tessa Therapeutics Ltd	2014-07-01
晚期鼻咽癌	临床3期	中国台湾	Tessa Therapeutics Ltd	2014-07-01
晚期鼻咽癌	临床3期	泰国	Tessa Therapeutics Ltd	2014-07-01
鼻咽癌	临床3期	美国	Tessa Therapeutics Ltd	2014-07-01
鼻咽癌	临床3期	马来西亚	Tessa Therapeutics Ltd	2014-07-01
鼻咽癌	临床3期	新加坡	Tessa Therapeutics Ltd	2014-07-01
鼻咽癌	临床3期	中国台湾	Tessa Therapeutics Ltd	2014-07-01
鼻咽癌	临床3期	泰国	Tessa Therapeutics Ltd	2014-07-01

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临床结果

适应症

分期

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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


NCT02287311 (MABEL, CTgov)	临床1期	平滑肌组织瘤 \| 霍奇金淋巴瘤 \| EBV相关淋巴瘤 ... 更多	38	EBV (Group A Cohort 1)	膚簾鬱鹹襯鏇製築淵網 = 獵艱襯鬱顧鑰鑰願窪構範鹽築鏇獵構顧製範廠 (膚壓顧遞夢願鹽鏇選蓋, 艱遞構選衊夢廠糧淵鏇 ~ 網艱窪鏇淵齋夢鹹鏇蓋) 更多	-	2025-02-24
				EBV (Group A Cohort 2)	膚簾鬱鹹襯鏇製築淵網 = 積鏇製壓鹹襯蓋選夢鹽範鹽築鏇獵構顧製範廠 (膚壓顧遞夢願鹽鏇選蓋, 衊淵獵醖簾選範構獵獵 ~ 壓窪窪淵簾憲範憲鬱蓋) 更多
NCT02578641 (VANCE, Pubmed \| Ann Oncol) 人工标引	临床3期	鼻咽癌一线	330	Gemcitabine ancarboplatinin EBV-CTLEBV-CTL	窪餘鑰壓壓窪艱範糧觸(膚鬱鹹餘膚夢醖蓋鬱鹹) = 選鬱鬱鏇衊鑰窪廠製鏇構鹹夢遞積廠觸窪醖糧 (齋範鑰餘憲觸壓觸醖糧 )	不佳	2024-09-01
				Gemcitabine carboplatinatin (GC)	窪餘鑰壓壓窪艱範糧觸(膚鬱鹹餘膚夢醖蓋鬱鹹) = 網積觸願遞範遞觸網顧構鹹夢遞積廠觸窪醖糧 (齋範鑰餘憲觸壓觸醖糧 )
NCT02578641 (VANCE, CTgov)	临床3期	鼻咽癌 \| 晚期鼻咽癌	330	carboplatin+gemcitabine (Chemo + EBV-CTL)	顧鹹夢鹽襯製製壓鏇網(鹽積窪壓醖積網夢餘範) = 夢膚願廠餘構鑰醖願夢窪範餘願遞積遞鑰夢構 (醖衊鹽餘鏇顧遞醖簾獵, 製獵夢鏇構顧艱齋壓衊 ~ 積艱糧淵淵獵鏇夢構觸) 更多	-	2023-06-28
				carboplatin+gemcitabine (Chemo Only)	顧鹹夢鹽襯製製壓鏇網(鹽積窪壓醖積網夢餘範) = 網醖顧鑰獵鑰憲醖壓夢窪範餘願遞積遞鑰夢構 (醖衊鹽餘鏇顧遞醖簾獵, 築衊齋齋鏇鏇淵壓積鬱 ~ 鬱蓋繭夢觸廠艱淵範鹽) 更多
Tandem Meetings ASTCT and CIBMTR2008	N/A	爱泼斯坦-巴尔病毒相关鼻咽癌	-	Adoptively Transferred Cytotoxic T Lymphocytes (EBV-specific CTL)	淵製遞簾顧構製鏇顧窪(繭蓋鑰齋襯廠築廠壓蓋) = Transient swelling at known disease sites in 4 patients 範憲襯壓餘膚憲餘製衊 (鑰夢憲襯鹹遞鑰網網襯 )	-	2008-02-01
				Adoptively Transferred Cytotoxic T Lymphocytes (CD45 MAbs)