CLIC-1901(CLIC-1901) - 药物靶点：CD19_在研适应症：急性淋巴细胞白血病，CD19 表达恶性肿瘤，慢性淋巴细胞白血病_专利_临床

概要

基本信息

药物类型

自体CAR-T

别名

autologous anti-CD19 Chimeric Antigen Receptor T cells

靶点

CD19

作用机制

CD19调节剂(B淋巴细胞抗原CD19调节剂)

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

急性淋巴细胞白血病CD19 表达恶性肿瘤慢性淋巴细胞白血病

非在研适应症-

原研机构

Ottawa Hospital Research Institute

在研机构

Ottawa Hospital Research Institute

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)-

特殊审评-

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关联

2

项与 CLIC-1901 相关的临床试验

NCT03765177 / Recruiting临床1/2期IIT

Canadian-Led Immunotherapies in Cancer: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies

The investigators propose an early phase study defined as a phase I/II trial assessing safety, feasibility and efficacy of CLIC-1901 autologous anti-CD19 Chimeric Antigen Receptor T cells (CAR-T) cells for participants with relapsed/refractory CD19 positive (CD19+) Acute Lymphoblastic Leukemia (ALL) and non-Hodgkin's Lymphoma (NHL). The Initial Stage of the study (n=20 participants) will focus on feasibility and safety while the Extended Stage will include all participants enrolled in the study (n=additional 80 participants for a total of 100) and will focus on efficacy and safety outcomes. In the proposed trial, we will administer our CAR-T cell product to these participants as a single infusion. Participants will undergo (a) lymphodepletion with cyclophosphamide and fludarabine, followed by (b) infusion of autologous CLIC-1901 CAR-T cells. All treatments will be delivered intravenously.

开始日期2019-10-16

申办/合作机构

Ottawa Hospital Research Institute

EUCTR2017-002088-16-IT / Unknown status临床1/2期IIT

Phase I/II study of anti-CD19 Chimeric Antigen Receptor-Expressing T cells in pediatric patients affected by relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Non Hodgkin Lymphoma - CD19-CAR01

开始日期2017-12-22

申办/合作机构-

100 项与 CLIC-1901 相关的临床结果

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100 项与 CLIC-1901 相关的转化医学

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100 项与 CLIC-1901 相关的专利（医药）

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29

项与 CLIC-1901 相关的文献（医药）

2024-01-01·Journal of Pediatric Hematology/Oncology

Cerebral Spinal Fluid Parameters Following CD19-Targeted Therapies in Children and Young Adults

Article

作者: Leib, Shiran ; Vernitsky, Helly ; Toren, Amos ; Aharony-Tevet, Yarden ; Jacoby, Elad ; Bielorai, Bella

The presence of leukocytes in the cerebral spinal fluid (CSF) of patients with acute lymphoblastic leukemia may indicate a relapse in the central nervous system. CD19-directed immunotherapy may increase the blood-brain barrier permeability, leading to neurologic toxicity and infiltrate the CNS. We studied the CSF cell and protein content in 71 consecutive patients who received either CD19 chimeric antigen receptor T cells or blinatumomab. Responding patients had an incidence of 66% and 61% of pleocytosis following blinatumomab or chimeric antigen receptor T cells, respectively. CSF parameters did not correlate with toxicity or prior CNS disease. Routine CSF flow cytometry following immunotherapy to distinguish T-cell infiltration from CNS relapse should be considered.

2023-04-01·Hematological Oncology3区 · 医学

Efficacy of programmed cell death 1 inhibitor maintenance therapy after combined treatment with programmed cell death 1 inhibitors and anti‐CD19‐chimeric antigen receptor T cells in patients with relapsed/refractory diffuse large B‐cell lymphoma and high tumor burden

3区 · 医学

Article

作者: Deng, Haobin ; Yuan, Jijun ; Mu, Juan ; Lyu, Cuicui ; Jiang, Yanyu ; Li, Qing ; Deng, Qi ; Wang, Jia ; Shen, Jichun

AbstractWe studied the efficacy and safety of the combined treatment with programmed cell death 1 (PD‐1) inhibitors and anti‐CD19 chimeric antigen receptor (CAR) T‐cell therapy and subsequent PD‐1 inhibitor maintenance treatment in patients with relapsed/refractory (R/R) diffuse large B‐cell lymphoma (DLBCL) and high tumor burden. Forty‐four R/R DLBCL patients with high tumor burden were enrolled in this study. The experimental group of 26 patients received combined therapy with PD‐1 inhibitors and anti‐CD19‐CAR T cells, while the control group of 18 patients received anti‐CD19‐CAR T‐cell therapy alone. The objective response rate (ORR) was 65.39% and 61.11% in the combination and control groups, respectively. The PD‐1 inhibitor maintenance therapy was selected for patients who achieved complete response or partial response in the combination therapy group. Progression‐free survival and overall survival rates in the combination group were higher than those in the control group 3 and 12 months after CAR T‐cell infusion. There was no significant difference in the grade of cytokine release syndrome or immune effector cell associated neurotoxic syndrome between the two groups. In the maintenance therapy group, only eight patients experienced grade 1 Common Terminology Criteria for Adverse Events (CTCAE) and three grade 2 CTCAE. Overall, we found that the ORR was not affected by the combination therapy with PD‐1 inhibitors and anti‐CD19‐CAR T cells. However, patients who had achieved the ORR might benefit from PD‐1 inhibitor maintenance therapy after combination therapy without increased side effects.

2022-06-01·Pediatric Blood & Cancer

Successful administration of CD19 chimeric antigen receptor T cells in association with severe cyanotic congenital heart disease

Article

作者: Gakenheimer‐Smith, Lindsey ; Harris, Andrew ; Afify, Zeinab ; Staab, Ambur ; Boyer, Michael

100 项与 CLIC-1901 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
急性淋巴细胞白血病	临床2期	加拿大	Ottawa Hospital Research Institute	2019-10-16
CD19 表达恶性肿瘤	临床2期	加拿大	Ottawa Hospital Research Institute	2019-10-16
慢性淋巴细胞白血病	临床2期	加拿大	Ottawa Hospital Research Institute	2019-10-16