T-Cells(Key Biologics)(T-Cells(Key Biologics)) - 在研适应症：转移性黑色素瘤_专利_临床

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

细胞替代物

治疗领域

肿瘤皮肤和肌肉骨骼疾病

在研适应症

转移性黑色素瘤

非在研适应症-

原研机构

Key Biologics LLC

在研机构

Prometheus Biosciences, Inc.Key Biologics LLC

非在研机构-

最高研发阶段临床2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

2

项与 T-Cells(Key Biologics) 相关的临床试验

NL-OMON46564

/ WithdrawnN/AIIT

T cells and innate lymphoid cells (ILCs) in cutaneous graft-versus-host disease - TIC Study

开始日期-

申办/合作机构-

NCT00338377

/ Active, not recruiting临床2期IIT

Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma

Objectives:
The primary objective will be to determine whether patients receiving the combination of dendritic cells and high dose IL-2 (Cohort A) have sustained persistence of infused T cells compared to patients treated with T cells and high dose IL-2 alone.
Secondary endpoints will include evaluations for tumor response and studies to determine whether dendritic cells enhance the infused T cells in anti-tumor activity and their ability to migrate to the tumor site. In addition, we will evaluate the characteristics of the infused T cells that correspond with effectiveness in vivo.
Additionally, secondary objectives will include correlation of clinical parameters with survival (overall survival and progression-free survival) for all cohorts.
COHORT C
In a separate cohort (Cohort C) the primary endpoint will be the overall response rate of TIL treatment for patients who have not achieved PR or CR or have progressive disease from treatment of the BRAF inhibitor alone.
COHORT D
The primary objective of Cohort D is to confirm the safety of adoptively transferred, TIL into the CSF.
The secondary objective is the evaluation of clinical imaging and CSF response. Correlative objectives will assess if the intrathecally-infused T cells persist in the CSF, assess circulating tumor cells in the CSF, and assess various cytokine and other analyses,as feasible.
COHORT E
The primary objective of Cohort E is to determine the overall response rate of TIL treatment with cells grown by the TIL 3.0 pre-REP (Turnstile 1) phase of cellular growth.

开始日期2006-02-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+3]

100 项与 T-Cells(Key Biologics) 相关的临床结果

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100 项与 T-Cells(Key Biologics) 相关的转化医学

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100 项与 T-Cells(Key Biologics) 相关的专利（医药）

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21

项与 T-Cells(Key Biologics) 相关的文献（医药）

2024-02-01·Leukemia

Cellular dynamics following CAR T cell therapy are associated with response and toxicity in relapsed/refractory myeloma

Article

作者: Franke, Georg-Nikolaus ; Heyn, Simone ; Herling, Marco ; Merz, Maximilian ; Baber, Ronny ; Platzbecker, Uwe ; Weiss, Ronald ; Hell, Saskia ; Boldt, Andreas ; Kubasch, Anne Sophie ; Wang, Song Yau ; Ussmann, Jule ; Vucinic, Vladan ; Weidner, Heike ; Fischer, Luise ; Born, Patrick ; Franz, Paul ; Schwind, Sebastian ; Köhl, Ulrike ; Hoffmann, Sandra ; Jentzsch, Madlen ; Bach, Enrica ; Metzeler, Klaus H ; Kirchberg, Janine ; Reiche, Kristin ; Grieb, Nora ; Fricke, Stephan ; Seiffert, Sabine ; Sack, Ulrich

AbstractB-cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T cells revolutionized the treatment of relapsed/refractory multiple myeloma (RRMM). However, data on cellular (CAR) T cell dynamics and the association with response, resistance or the occurrence of cytokine release syndrome (CRS) are limited. Therefore, we performed a comprehensive flow cytometry analysis of 27 RRMM patients treated with Idecabtagene vicleucel (Ide-cel) to assess the expansion capacity, persistence and effects on bystander cells of BCMA-targeting CAR T cells. Additionally, we addressed side effects, like cytokine release syndrome (CRS) and cytopenia. Our results show that in vivo expansion of CD8+ CAR T cells is correlated to response, however persistence is not essential for durable remission in RRMM patients. In addition, our data provide evidence, that an increased fraction of CD8+ T cells at day of leukapheresis in combination with successful lymphodepletion positively influence the outcome. We show that patients at risk for higher-grade CRS can be identified already prior to lymphodepletion. Our extensive characterization contributes to a better understanding of the dynamics and effects of BCMA-targeting CAR T cells, in order to predict the response of individual patients as well as side effects, which can be counteracted at an early stage or even prevented.

2024-01-01·European Journal of Haematology

Enhanced efficacy of CD19/CD22 bispecific CAR‐T cells with EAAAK linker on B‐cell malignancies

Article

作者: Zhang, Tingting ; Tian, Xiaopeng ; You, Fengtao ; Ma, Renyuxue ; Yang, Lin ; Tian, Shuaiyu ; Yang, Nan ; Wu, Hai ; An, Gangli ; Xiang, Shufen

AbstractObjectivesDespite the great success of CD19 CAR‐T cell therapy, its clinical efficacy has been greatly hampered by the high relapse rate. In this study, we designed and compared four structures of CD19/CD22 bispecific CAR‐T cells with different linkers and different orders of the antibody sequences.MethodsWe detected the cytotoxicity, cytokine secretion levels, sustainable killing ability, differentiation, exhaustion of these four CAR‐T cells in vitro. The optimal Bis‐C CAR‐T cells were evaluated the efficacy using NSG mice.ResultsThe two structures of CD19/CD22 bispecific CAR‐T cells using (EAAAK)3 as linker had more significant cytotoxicity and cytokine secretion levels. In the process of continuous killing, Bis‐C CAR‐T cells showed better sustained killing ability, memory phenotype differentiation, and exhaustion. In the in vivo experiment mimicking CD19‐negative relapse, Bis‐C CAR‐T was more able to control the tumor progression of mice in the CD19 low expression or no expression groups than CD19 CAR‐T.ConclusionsThis study has generated a novel bispecific CAR‐T cell that can simultaneously target CD19 or CD22 positive tumor cells, providing a new strategy to address the limitations of single‐targeted CAR‐T therapy in B‐cell tumors (limited response or relapse).

2023-12-31·OncoImmunology

Mesothelin-targeting T cells bearing a novel T cell receptor fusion construct (TRuC) exhibit potent antitumor efficacy against solid tumors

Article

作者: Geirut, Jessica ; Tighe, Robert ; Schrand, Brett ; Delgoffe, Greg ; Guyette, Sarah ; Hofmeister, Robert ; Menk, Ashley ; Ding, Jian ; Horton, Holly ; Guo, Guangwu ; Baeuerle, Patrick A.

T cell Receptor (TCR) Fusion Construct (TRuC®) T cells harness all signaling subunits of the TCR to activate T cells and eliminate tumor cells, with minimal release of cytokines. While adoptive cell therapy with chimeric antigen receptor (CAR)-T cells has shown unprecedented clinical efficacy against B-cell malignancies, monotherapy with CAR-T cells has suboptimal clinical efficacy against solid tumors, probably because of the artificial signaling properties of the CAR. TRuC-T cells may address the suboptimal efficacy of existing CAR-T therapies for solid tumors. Here, we report that mesothelin (MSLN)-specific TRuC-T cells (referred to as TC-210 T cells) potently kill MSLN+ tumor cells in vitro and efficiently eradicate MSLN+ mesothelioma, lung, and ovarian cancers in xenograft mouse tumor models. When benchmarked against MSLN-targeted BBζ CAR-T cells (MSLN-BBζ CAR-T cells), TC-210 T cells show an overall comparable level of efficacy; however, TC-210 T cells consistently show faster tumor rejection kinetics that are associated with earlier intratumoral accumulation and earlier signs of activation. Furthermore, in vitro and ex vivo metabolic profiling suggests TC-210 T cells have lower glycolytic activity and higher mitochondrial metabolism than MSLN-BBζ CAR-T cells. These data highlight TC-210 T cells as a promising cell therapy for treating MSLN-expressing cancers. The differentiated profile from CAR-T cells may translate into better efficacy and safety of TRuC-T cells for solid tumors.

100 项与 T-Cells(Key Biologics) 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
转移性黑色素瘤	临床2期	美国	Prometheus Biosciences, Inc.	2006-02-01
转移性黑色素瘤	临床2期	美国	Key Biologics LLC	2006-02-01

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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


ICML2019	N/A	套细胞淋巴瘤	-	Lisocabtagene maraleucel dose level 1 (50 × 10 6 total CAR+ T cells)	(顧繭襯範範艱範蓋窪鏇) = 鬱選選鹽構顧鹹醖獵窪構獵壓憲淵醖夢範齋網 (觸繭積構壓膚觸糧廠蓋 )	-	2019-06-12
ASGCT2011	N/A	-	-	mIL15+CAR+ T cells	願築製觸鏇積憲襯繭構(壓願憲齋鹽積築艱鬱範) = 膚蓋遞鹽製遞糧齋觸獵獵膚齋憲鏇餘鹹獵積顧 (糧獵衊網廠鹹鬱艱範製 )	-	2011-05-01
ASGCT2011	N/A	-	-	IL-15 (CAR+ T cells)	願築製觸鏇積憲襯繭構(壓願憲齋鹽積築艱鬱範) = 襯廠壓膚獵願鏇壓遞觸獵膚齋憲鏇餘鹹獵積顧 (糧獵衊網廠鹹鬱艱範製 )	-	2011-05-01
ASGCT2007	N/A	-	-	VRX496-modified CD4+ T cells	願積願夢繭繭繭簾鹽鹹(願糧網廠壓窪糧鹽積願) = 鑰鹽淵醖廠鹽鑰簾選獵範餘餘觸鑰鬱糧製鹹艱 (淵鹹獵顧鑰鏇壓積範鑰 ) 更多	-	2007-05-01
VRX496 Phase II (ASGCT2006)	临床2期	-	11	VRX496-modified HIV+, CD4+ T cells	鹽壓膚窪築築遞窪顧製(壓鬱壓鬱選餘淵餘選憲) = 網鏇蓋選廠構壓選遞積構鹽糧窪繭願窪艱憲衊 (齋衊選鏇獵襯衊築壓鹽 ) 更多	积极	2006-08-01