Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology)(Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology)) - 药物靶点：CD19 x CD22_在研适应症：CD19阳性B细胞急性淋巴细胞白血病，难治性 B 细胞急性淋巴细胞白血病_专利_临床

概要

基本信息

药物类型

自体CAR-T

别名

AntiCD19/CD22 CART cell therapy Shanghai UnicarTherapy Biomedicine Technology

靶点

CD19 x CD22

作用机制

CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、CD22抑制剂(CD22抑制剂)、基因转移

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治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病

在研适应症

CD19阳性B细胞急性淋巴细胞白血病难治性 B 细胞急性淋巴细胞白血病

非在研适应症

难治性B细胞淋巴瘤难治性非霍奇金淋巴瘤复发性非霍奇金淋巴瘤

原研机构

上海优卡迪生物医药科技有限公司

在研机构

上海优卡迪生物医药科技有限公司

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

3

项与 Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) 相关的临床试验

NCT04539444 / Unknown status临床2期IIT

A Study Evaluated Efficacy and Safety of CD19/22 Chimeric Antigen Receptor T Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma.

开始日期2020-08-01

申办/合作机构

苏州大学附属第一医院

[+1]

NCT03468153 / Unknown status临床1/2期IIT

The Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.

开始日期2018-01-01

申办/合作机构

上海交通大学医学院附属瑞金医院

[+1]

NCT03614858 / Recruiting临床1/2期

Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

开始日期2017-09-01

申办/合作机构

上海优卡迪生物医药科技有限公司

[+1]

100 项与 Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) 相关的临床结果

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100 项与 Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) 相关的转化医学

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100 项与 Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) 相关的专利（医药）

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1

项与 Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) 相关的文献（医药）

Frontiers in Immunology

Case Report: Post-CAR-T Infusion HBV Reactivation in Two Lymphoma Patients Despite Entecavir Preventive Therapy

作者: Zheng, Miao ; Yang, Li ; Bao, Yuhan ; Yang, Yang ; Ma, Yaxian ; Chen, Liting

Hepatitis B virus (HBV) reactivation is a common complication in chronic or resolved HBV infection patients undergoing immunosuppressive chemotherapy. Furthermore, few articles have been published regarding the risk of HBV reactivation in lymphoma patients receiving chimeric antigen receptor (CAR) T-cell therapy and anti-HBV prophylaxis. Few guidelines or clear optimal strategies are available for managing these patients. Here, we present two cases of patients who underwent CAR-T-cell cocktail therapy with anti-CD19 and anti-CD22 CAR (CAR19/22) T cell for lymphoma. Patients had previous history of HBV infection, and blood tests on initial admission indicated positive results for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), and antibody to hepatitis B e antigen (anti-HBe), while serum HBV DNA level was undetectable. Therefore, two patients received entecavir as antiviral prophylactic therapy during their entire treatment. They were diagnosed with HBV reactivation based on positive serum HBV DNA test results, 2 weeks after CAR-T-cell infusion. Liver function assay indicated elevated levels of alanine transaminase (ALT) and aspartate transaminase (AST), combined with increased levels of total bilirubin (TBIL) and direct bilirubin (DBIL). Subsequently, they received anti-HBV treatment with entecavir and tenofovir. As a result, their serum HBV DNA copies and AST/ALT levels returned to normal after 1 week. These cases show that there is a risk of HBV reactivation in lymphoma patients with CAR-T-cell therapy despite entecavir preventive therapy, and combination treatment of entecavir and tenofovir may be an effective treatment option for such patients with HBV reactivation.

100 项与 Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) 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
难治性B细胞淋巴瘤	临床2期	中国	上海优卡迪生物医药科技有限公司	2020-08-01
难治性非霍奇金淋巴瘤	临床2期	中国	上海优卡迪生物医药科技有限公司	2020-08-01
复发性非霍奇金淋巴瘤	临床2期	中国	上海优卡迪生物医药科技有限公司	2020-08-01
CD19阳性B细胞急性淋巴细胞白血病	临床2期	中国	上海优卡迪生物医药科技有限公司	2017-09-01
难治性 B 细胞急性淋巴细胞白血病	临床2期	中国	上海优卡迪生物医药科技有限公司	2017-09-01

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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


NCT03614858 \| NCT03919240 (ASH2021) 人工标引	临床1/2期	CD19阳性B细胞急性淋巴细胞白血病	-	Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) (tandem)	(顧願選醖蓋餘醖觸願選) = Severe cytokine release syndrome (CRS, Grade ≥ 3) occurred in 25.0% of patients in CD19 group, 18.4% of patients in tandem CD19/CD22 group, and 23.1% in sequential CD19/CD22 group (P=0.641). 簾淵糧繭醖簾網積簾獵 (繭製壓憲廠衊憲糧憲憲 )	积极	2021-11-05
				Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) (sequential)