CD19 and CD22 CAR-T(Yake Biotechnology)(CD19 and CD22 CAR-T(Yake Biotechnology)) - 药物靶点：CD19 x CD22_在研适应症：费城染色体阳性急性淋巴细胞白血病，前体B细胞急性淋巴细胞白血病，费城染色体阴性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-

靶点

CD19 x CD22

作用机制

CD19调节剂(B淋巴细胞抗原CD19调节剂)、CD22调节剂(CD22调节剂)、免疫细胞毒性

+ [1]

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

费城染色体阳性急性淋巴细胞白血病前体B细胞急性淋巴细胞白血病费城染色体阴性急性淋巴细胞白血病

非在研适应症-

原研机构

上海雅科生物科技有限公司

在研机构

上海雅科生物科技有限公司

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)临床2期

特殊审评-

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关联

2

项与 CD19 and CD22 CAR-T(Yake Biotechnology) 相关的临床试验

NCT04788472 / Completed临床2期IIT

Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients with Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia

Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia

开始日期2021-03-05

申办/合作机构

浙江大学

[+1]

NCT04740203 / Recruiting临床1/2期IIT

Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia

开始日期2021-01-31

申办/合作机构

浙江大学

[+1]

100 项与 CD19 and CD22 CAR-T(Yake Biotechnology) 相关的临床结果

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100 项与 CD19 and CD22 CAR-T(Yake Biotechnology) 相关的转化医学

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100 项与 CD19 and CD22 CAR-T(Yake Biotechnology) 相关的专利（医药）

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2

项与 CD19 and CD22 CAR-T(Yake Biotechnology) 相关的文献（医药）

2021-06-01·American Journal of Hematology1区 · 医学

Combination of CD19 and CD22 CAR‐T cell therapy in relapsed B‐cell acute lymphoblastic leukemia after allogeneic transplantation

1区 · 医学

Article

作者: Yu, Xinjian ; Chen, Bingzhen ; Deng, Biping ; Pan, Jing ; Tong, Chunrong ; Lin, Yuehui ; An, Lihong ; Wu, Tong ; Yin, Zhichao ; Liu, Shuangyou ; Liu, Dan ; Chang, Alex H.

AbstractThe prognosis of relapsed acute lymphoblastic leukemia (ALL) after allogeneic transplantation is dismal when treated with conventional approaches. While single‐target CD19 or CD22 chimeric antigen receptor (CAR) T‐cell therapy has achieved high complete remission (CR) rates in refractory/relapsed B‐ALL, it could not maintain a durable remission in most patients. To prolong relapse‐free survival, we sequentially combined CD19 and CD22 CAR‐T cells to treat post‐transplant relapsed B‐ALL patients with both CD19/CD22 antigen expression on lymphoblasts. Patient‐derived donor cells were collected to produce CAR‐T cells that were transfected by lentiviral vectors encoding second generation CARs composed of CD3ζ and 4–1BB. The second T‐cell infusion was scheduled at least 1 month, and usually within 6 months after the first CAR‐T treatment. Twenty‐seven adult and pediatric patients, including 11 (41%) with extramedullary diseases (EMD), received the first CD19 CAR‐T and 23 (85%) achieved CR. Subsequently, 21 out of 27 patients received the second CD22 CAR‐T and were followed‐up for a median of 19.7 (range, 5.6–27.3) months; 14 cases remained in CR, seven relapsed and two of them died from disease progression; Kaplan–Meier survival analysis showed overall survival and event‐free survival rates of 88.5% and 67.5%, respectively, at both 12 months and 18 months. CAR‐T associated graft‐versus‐host disease (GVHD) occurred in 23% of patients, with 8% new‐onset acute GVHD and 15% persistent or worsened pre‐existing cGVHD before CAR‐T. This combination strategy of sequential CD19 and CD22 CAR‐T therapy significantly improved the long‐term survival in B‐ALL patients who relapsed after transplantation.

2018-01-01·Nature Medicine1区 · 医学

CD22-targeted CAR T cells induce remission in B-ALL that is naive or resistant to CD19-targeted CAR immunotherapy

1区 · 医学

Article

作者: Fountaine, Thomas J ; Dropulic, Boro ; Dimitrov, Dimiter S ; Stroncek, David F ; Orentas, Rimas J ; Mackall, Crystal L ; Yates, Bonnie ; Ramakrishna, Sneha ; Delbrook, Cindy ; Shalabi, Haneen ; Martin, Staci ; Yuan, Constance M ; Stetler-Stevenson, Maryalice ; Sabatino, Marianna ; Fry, Terry J ; Feng, Yang ; Lee, Daniel W ; Shern, Jack F ; Nguyen, Sang ; Qin, Haiying ; Shah, Nirali N ; Majzner, Robbie G ; Wolters, Pamela ; Zhang, Ling

Chimeric antigen receptor (CAR) T cells targeting CD19 mediate potent effects in relapsed and/or refractory pre-B cell acute lymphoblastic leukemia (B-ALL), but antigen loss is a frequent cause of resistance to CD19-targeted immunotherapy. CD22 is also expressed in most cases of B-ALL and is usually retained following CD19 loss. We report results from a phase 1 trial testing a new CD22-targeted CAR (CD22-CAR) in 21 children and adults, including 17 who were previously treated with CD19-directed immunotherapy. Dose-dependent antileukemic activity was observed, with complete remission obtained in 73% (11/15) of patients receiving ≥1 × 10⁶ CD22-CAR T cells per kg body weight, including 5 of 5 patients with CD19^dim or CD19^- B-ALL. Median remission duration was 6 months. Relapses were associated with diminished CD22 site density that likely permitted CD22⁺ cell escape from killing by CD22-CAR T cells. These results are the first to establish the clinical activity of a CD22-CAR in B-ALL, including leukemia resistant to anti-CD19 immunotherapy, demonstrating potency against B-ALL comparable to that of CD19-CAR at biologically active doses. Our results also highlight the critical role played by antigen density in regulating CAR function.

100 项与 CD19 and CD22 CAR-T(Yake Biotechnology) 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
费城染色体阳性急性淋巴细胞白血病	临床2期	中国	上海雅科生物科技有限公司	2021-03-05
前体B细胞急性淋巴细胞白血病	临床2期	中国	上海雅科生物科技有限公司	2021-03-05
费城染色体阴性急性淋巴细胞白血病	临床2期	中国	上海雅科生物科技有限公司	2021-01-31