A Phase 2 Open Label Study to Investigate the Safety and Clinical Activity of Autologous EBV-specific T Cells (CMD-003) for the Treatment of Patients With EBV Positive Lymphomas

To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.

开始日期2016-11-01

申办/合作机构

Kuur Therapeutics Ltd.

NCT01948180 / Terminated临床2期

A Phase 2 Single Arm Study to Investigate the Efficacy of Autologous EBV-specific T-cells for the Treatment of Patients With Aggressive EBV Positive Extranodal NK/T-cell Lymphoma (ENKTCL)

To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma

开始日期2014-09-01

申办/合作机构

Kuur Therapeutics Ltd.

100 项与 Baltaleucel-T (CAGT/Kuur Therapeutics) 相关的临床结果

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100 项与 Baltaleucel-T (CAGT/Kuur Therapeutics) 相关的转化医学

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100 项与 Baltaleucel-T (CAGT/Kuur Therapeutics) 相关的专利（医药）

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项与 Baltaleucel-T (CAGT/Kuur Therapeutics) 相关的文献（医药）

2021-10-01·Annals of Hematology3区 · 医学

Autologous EBV-specific T cell treatment results in sustained responses in patients with advanced extranodal NK/T lymphoma: results of a multicenter study

3区 · 医学

Article

作者: Murray, Maryann ; Suh, Cheolwon ; Combs, Katherin E ; Lee, Hun Ju ; Lee, Daniel Y ; Suarez, Felipe ; Budde, Lihua E ; Bollard, Catherine M ; Heslop, Helen E ; Radford, John ; Kim, Jin Seok ; Inman, Shannon ; Kim, Seok Jin ; Yoon, Sang Eun ; Gunter, Kurt C ; Oki, Yasuhiro ; Rooney, Cliona M ; Jacobsen, Eric D ; Bachy, Emmanuel ; Yoon, Dok Hyun ; Kim, Won Seog ; Ardeshna, Kirit M ; Ruan, Jia ; Kang, Hye Jin ; Lin, Yi ; Brammer, Jonathan E ; Jaccard, Arnaud ; Porcu, Pierluigi ; Advani, Ranjana

We conducted a phase II clinical trial to develop an autologous EBV-specific T cell product (baltaleucel T) for advanced, relapsed ENKTL. Among 47 patients who provided whole blood starting material for manufacturing the product, 15 patients received a median of 4 doses of baltaleucel T. Thirty-two (68%) patients did not receive baltaleucel-T due to manufacturing failure, rapid disease progression, and death. Of the 15 patients, 10 patients had measurable disease at baseline (salvage cohort), and 5 patients had no disease at baseline assessment (adjuvant cohort). In the 15 patients, the median follow-up duration was 10.2 months (range 2.0-23.5 months), median progression-free survival (PFS) was 3.9 months, and the median overall survival (OS) was not reached. Patients in the salvage cohort achieved a 30% complete response (CR) and a 50% overall response rate (ORR). In the adjuvant cohort, disease progression was reported in three patients and two patients did not relapse during study follow-up. When we compared survival outcomes of seven responders and eight non-responders, the PFS (P = 0.001) and OS (P = 0.014) of responders proved statistically superior to that of non-responders. Baltaleucel-T was well tolerated. We have performed a phase II clinical trial of autologous EBV-specific T cell treatment (baltaleucel-T) in R/R ENKTL. Autologous EBV-specific T cells were well tolerated and demonstrated single-agent activity in R/R ENTKL.

100 项与 Baltaleucel-T (CAGT/Kuur 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
弥漫性大B细胞淋巴瘤	临床2期	美国	Kuur Therapeutics Ltd.	2016-11-01
EBV相关淋巴瘤	临床2期	美国	Kuur Therapeutics Ltd.	2016-11-01
霍奇金淋巴瘤	临床2期	美国	Kuur Therapeutics Ltd.	2016-11-01
移植后淋巴增生性疾病	临床2期	美国	Kuur Therapeutics Ltd.	2016-11-01
鼻咽肿瘤	临床2期	美国	Baylor College of Medicine	2009-11-09
爱泼斯坦-巴尔病毒感染	临床2期	美国	Center For Cell & Gene Therapy	-

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临床结果

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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


NCT02763254 (CIVIC, CTgov)	临床2期	霍奇金淋巴瘤 \| 移植后淋巴增生性疾病 \| EBV相关淋巴瘤 \| 弥漫性大B细胞淋巴瘤	1	baltaleucel-T	範憲糧鬱製簾鹹艱憲範(壓夢製齋齋蓋糧鹹鏇鏇) = 積簾糧餘膚積願淵糧範淵壓鏇簾繭夢醖鏇蓋網 (觸餘獵顧製範積選淵窪, 鹹窪壓憲衊餘範糧醖鬱 ~ 獵齋繭觸顧願繭顧壓鏇) 更多	-	2019-03-12
NCT01948180 (CITADEL, SITC2018)	临床2期	结外NK-T细胞淋巴瘤辅助 EBV expression	15	Baltaleucel T	鬱選艱壓廠範餘齋廠繭(簾顧窪範壓鹽醖醖簾網) = 鏇鏇鬱鹽顧觸淵鏇蓋積糧簾醖壓製繭獵壓築廠 (衊積簾鹹簾蓋鏇鑰廠壓 ) 更多	积极	2018-11-06