CD19/BCMA-CAR-T cells(Essen Biotech)(CD19/BCMA-CAR-T cells(Essen Biotech)) - 药物靶点：BCMA x CD19_在研适应症：肉芽肿伴多血管炎，特发性炎症性肌病，狼疮性肾炎_专利_临床

概要

基本信息

药物类型

CAR-T

别名

靶点

BCMA x CD19

作用机制

BCMA调节剂(B细胞成熟蛋白调节剂)、CD19调节剂(B淋巴细胞抗原CD19调节剂)

治疗领域

免疫系统疾病神经系统疾病心血管疾病+ [6]

在研适应症

肉芽肿伴多血管炎特发性炎症性肌病狼疮性肾炎+ [3]

非在研适应症-

原研机构

Essen Biotech

在研机构

Essen Biotech

非在研机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)临床1/2期

特殊审评-

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关联

2

项与 CD19/BCMA-CAR-T cells(Essen Biotech) 相关的临床试验

NCT06350110 / Recruiting临床1/2期IIT

T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement

This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.

开始日期2024-07-10

申办/合作机构

Essen Biotech

NCT06428188 / Recruiting临床1/2期IIT

Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed/ Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease.

开始日期2024-05-29

申办/合作机构

Essen Biotech

100 项与 CD19/BCMA-CAR-T cells(Essen Biotech) 相关的临床结果

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100 项与 CD19/BCMA-CAR-T cells(Essen Biotech) 相关的转化医学

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100 项与 CD19/BCMA-CAR-T cells(Essen Biotech) 相关的专利（医药）

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6

项与 CD19/BCMA-CAR-T cells(Essen Biotech) 相关的文献（医药）

2024-08-01·Cytotherapy

Comprehensive characterization of cytopenia after chimeric antigen receptor-T cell infusion in patients with relapsed or refractory multiple myeloma

Article

作者: Chen, Yegan ; Sun, Cai ; Shi, Ming ; Li, Li ; Cheng, Hai ; Sun, Yingjun ; Qi, Kunming ; Shao, Lingyan ; Wang, Xue ; Zheng, Junnian ; Wu, Qingyun ; Qiao, Jianlin ; Xu, Kailin ; Wang, Dandan ; Cao, Jiang ; Zeng, Lingyu ; Liu, Jiaying ; Chen, Wei ; Li, Zhenyu ; Sang, Wei ; Chen, Zihan

BACKGROUNDMany studies have demonstrated the effectiveness of chimeric antigen receptor-T (CAR-T) cell therapy for relapsed or refractory multiple myeloma (RRMM), but the hematologic toxicity has not been well characterized.METHODSA total of 111 adults with RRMM who received BCMA CAR-T cells, BCMA + CD19 CAR-T cells or tandem BCMA/CD19 dual-target (BC19) CAR-T cells infusion were enrolled. We characterized cytopenia and hematologic recovery at different time points after CAR-T-cell therapy, analyzed the effect of cytopenia on prognosis and identified the risk factors.RESULTSPatients had a high probability of cytopenia, with anemia, neutropenia and thrombocytopenia occurring in 92%, 95% and 73%, respectively. There were 60 (54%) patients had prolonged hematologic toxicity (PHT) after D28. The median hemoglobin and platelet count were significantly lower at D28 post-CAR-T cell therapy than at baseline. Hemoglobin increased to above baseline at D90. The median absolute neutrophil count was lower than baseline at D0 and D28, and it recovered to baseline at D180. The baseline level of lactate dehydrogenase was associated with thrombocytopenia. Extramedullary involvement was associated with hemoglobin recovery, while the baseline level of albumin and types of CAR-T were related to platelet recovery. Patients with anemia at baseline and at D0, D180 and D360 had shorter progression-free survival (PFS), while anemia at D0, D60, D180 and D360 was associated with shorter overall survival (OS). Neutropenia at D0 was associated with shorter PFS and patients with neutropenia at D90 or D180 had shorter OS. Patients with thrombocytopenia at any time had shorter PFS and OS. Compared to patients without PHT, patients with PHT had shorter PFS and OS.CONCLUSIONSThe majority of RRMM patients treated with CAR-T cells experienced cytopenia. Cytopenia occurred at specific time points was associated with a poorer prognosis.

2021-10-21·Blood1区 · 医学

Development of CAR T-cell lymphoma in 2 of 10 patients effectively treated withpiggyBac-modified CD19 CAR T cells

1区 · 医学

Letter

作者: O’Brien, Tracey A. ; McCaughan, Georgia ; Jiang, Wei ; Sutrave, Gaurav ; Moezzi, Leili ; Maddock, Karen ; Street, Janine A. ; Gottlieb, David J. ; Mathew, Geetha ; Clancy, Leighton E. ; Avdic, Selmir ; Bishop, David C. ; Shaw, Peter J. ; Lee, Koon ; Antonenas, Vicki ; Simms, Renee ; Burgess, Jane ; Micklethwaite, Kenneth P. ; McGuire, Helen M. ; Atkins, Elissa ; Blyth, Emily ; Gloss, Brian S. ; Irving, David O.

CD19 -specific chimeric antigen receptor (CAR19) T cells induce remission of B cell malignancy, but manufacture of individualized autologous products with viral vectors is expensive, delays treatment, risks contamination with malignant B cells, and is not feasible in patients with insufficient healthy T cells.Generation of CAR19 T cells using an allogeneic donor is a promising alternative strategy, but limited data exist regarding safety and efficacy.Here, authors demonstrate that allogeneic piggyBac CAR19 T cells administered post-HSCT achieve the efficacy seen with CAR T cells generated using viral vectors.However, recruitment to trials of piggyBac CAR19 T cells at our center has been voluntarily suspended while further investigations into the pathogenesis of CAR19 T-cell lymphoma take place.The ability of piggyBac to integrate a large amount of genetic material, and the absence of a requirement for detection of competent retrovirus or lentivirus in the final product, remain attractive characteristics of this system.

2020-01-01·Journal of International Medical Research4区 · 医学

Infusion of chimeric antigen receptor T cells against dual targets of CD19 and B-cell maturation antigen for the treatment of refractory multiple myeloma

4区 · 医学

ArticleOA

作者: Tang, Fang ; Zhu, Xiaming ; Ge, Yongqin ; Shang, Jingjing ; Lu, Yin

Objective To investigate the safety and efficacy of chimeric antigen receptor T (CAR-T) cell infusion in patients with refractory multiple myeloma (MM). Methods Sixteen patients diagnosed with refractory MM were included in this study. Patients received initial infusions of T-derived CD19/B-cell maturation antigen (BCMA) CAR-T cells with 100% CD19, followed by second infusions with 40% BCMA and third infusions with 60% BCMA. The total doses were 0.5–1 × 107/kg CD19 and 1.2 − 6.2 × 107/kg BCMA. Patients were monitored after infusion. Levels of interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor-α, and C-reactive protein were determined by enzyme-linked immunosorbent assay. Results Cytokine release syndrome (CRS) was observed in all 16 patients. Thirteen patients with CRS stage II−IV had persistent hyperthermia from 5−14 days after infusion, while most patients developed hyperthermia from 1 day after infusion and their temperatures returned to normal within 2−10 days. Levels of all factors were significantly elevated 2 days after infusion, peaked at 5 days, and then gradually decreased to normal levels. All inflammatory factors showed normal levels by 10 days after infusion. Conclusion Body temperature and levels of inflammatory factors all increased dramatically after infusion of CD19/BCMA CAR-T cells, but recovered to normal levels after appropriate treatment and nursing.

100 项与 CD19/BCMA-CAR-T cells(Essen Biotech) 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
肉芽肿伴多血管炎	临床2期	中国	Essen Biotech	2024-07-10
特发性炎症性肌病	临床2期	中国	Essen Biotech	2024-07-10
狼疮性肾炎	临床2期	中国	Essen Biotech	2024-07-10
显微镜下多血管炎	临床2期	中国	Essen Biotech	2024-07-10
系统性硬皮病	临床2期	中国	Essen Biotech	2024-07-10
干燥综合征	临床2期	中国	Essen Biotech	2024-05-29