CD5 CAR T cells(Beijing Boren Hospital)(CD5 CAR T cells(Beijing Boren Hospital))

概要

基本信息

药物类型

通用型CAR-T

别名

靶点

CD5

作用方式

抑制剂

作用机制

T细胞表面糖蛋白CD5抑制剂

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [1]

在研适应症-

非在研适应症

前体T淋巴细胞白血病淋巴瘤T细胞急性淋巴细胞白血病/淋巴瘤

原研机构

北京高博博仁医院有限公司

在研机构-

非在研机构

北京高博博仁医院有限公司

权益机构-

最高研发阶段终止临床1期

首次获批日期-

最高研发阶段(中国)终止

特殊审评-

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关联

3

项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的临床试验

NCT05487495

/ Withdrawn临床1期

First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T (CT125B) Cells ForRelapsed or Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T (CT125B) cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma. 9-18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.

开始日期2022-08-03

申办/合作机构

北京高博博仁医院有限公司

NCT05032599

/ Terminated临床1期

First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T Cells in Subjects with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.

开始日期2021-09-14

申办/合作机构

北京高博博仁医院有限公司

ChiCTR2000039519

/ Recruiting早期临床1期

A single-center, open, non-randomized, single-arm clinical trial of donor CD5-CAR T cells in the treatment of refractory/relapsed acute T lymphoblastic leukemia in children

开始日期2020-10-29

申办/合作机构

北京高博博仁医院有限公司

100 项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的临床结果

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100 项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的转化医学

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100 项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的专利（医药）

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2

项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的文献（医药）

2020-04-01·Stem Cell Reviews and Reports3区 · 医学

Characterization of an Anti-CD5 Directed CAR T-Cell against T-Cell Malignancies

3区 · 医学

Article

作者: Chen, Qi ; Pinz, Kevin G ; Zhang, Wenli ; Zhang, Hongyu ; Tse, Charlotte Olivia ; Feng, Jia ; Chen, Xi ; Sha, Sha ; Fan, Xing-Xing ; Cao, Yuanzhen ; Chen, Kevin H ; Wada, Masayuki ; Jiang, Xun ; Ma, Yupo ; Fang, Liu

T-cell malignancies often result in poor prognosis and outcome for patients. Immunotherapy has recently emerged as a revolutionary treatment against cancer, and the success seen in CD19 CAR clinical trials may extend to T cell diseases. However, a shared antigen pool coupled with the impact of T-cell depletion incurred by targeting T cell disease remain concepts to be clinically explored with caution. Here we report on the ability of T cells transduced with a CD5CAR to specifically and potently lyse malignant T-cell lines and primary tumors in vitro in addition to significantly improving in vivo control and survival of xenograft models of T-ALL. To extensively explore and investigate the biological properties of a CD5 CAR, we evaluated multiple CD5 CAR constructs and constructed 3 murine models to characterize the properties of CD5 down-regulation, the efficacy and specificity produced by different CD5 CAR construct designs, and the impact of incorporating a CD52 safety switch using CAMPATH to modulate the persistency and function of CAR cells. These data support the potential use of CD5CAR T cells in the treatment of T cell malignancies or refractory disease in clinical settings.

2015-08-20·Blood1区 · 医学

A T-cell–directed chimeric antigen receptor for the selective treatment of T-cell malignancies

1区 · 医学

Article

作者: Rouce, Rayne H. ; Mamonkin, Maksim ; Tashiro, Haruko ; Brenner, Malcolm K.

Key PointsT cells transduced with a CD5 CAR demonstrate limited and transient fratricide and expand ex vivo. CD5 CAR T cells eliminate T-ALL blasts in vitro and control disease progression in xenograft T-ALL mouse models.

100 项与 CD5 CAR T cells(Beijing Boren Hospital) 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
T细胞急性淋巴细胞白血病/淋巴瘤	临床1期	中国	北京高博博仁医院有限公司	2022-08-03
前体T淋巴细胞白血病淋巴瘤	临床1期	中国	北京高博博仁医院有限公司	2021-09-14

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05032599 (EHA 12024 \| EHA 22024) 人工标引	临床1期	T细胞急性淋巴细胞白血病复发	16	CD5CAR T cells	(築糧構鹹鬱繭願餘糧夢) = Adverse events within 30 days included grade 3-4 cytopenias (100%, 92% of which were present prior tolymphodepletion), grade 1-2 cytokine release syndrome (75%), grade 1-2 neurotoxicity (25%) and grade 1 skingraft-versus-host disease (GVHD)(69%) and one grade 3 infection (6%) with no dose-limiting toxicity. 窪鑰蓋獵顧餘選選糧衊 (網壓鑰繭蓋範鏇夢網蓋 )	积极	2024-05-14
NCT05032599 (EHA 12024 \| EHA 22024) 人工标引	临床1期	T细胞急性淋巴细胞白血病复发	16	CD5CAR T cells (received SCT at 35)		积极	2024-05-14
NCT05032599 (ASCO2022) 人工标引	临床1期	难治性 T 急性淋巴细胞白血病	5	CD5 CAR T cells(Beijing Boren Hospital)	(積襯壓壓選艱襯顧衊憲) = 餘廠選簾膚鹽製憲蓋窪壓簾鑰壓願選鹽廠築醖 (醖鬱廠製簾選網襯製齋 ) 更多	积极	2022-06-02