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Inaticabtagene Autoleucel (CNCT19) in adult relapsed or refractory B-cell acute lymphoblastic leukemia

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资源类型：
Pubmed体系：
作者：
Wang Ying[1] * ; Lv Lulu[2] * ; Song Yongping[3] ; Wei Xudong[4] ; Zhou Hongsheng[5] ; Liu Qifa[5] ; Xu Kailin[6] ; Yan Dongmei[6] ; Zhang Cheng[7] ; Liu Shuangyou[8] ; Jin Jie[9] ; Mei Heng[10] ; Niu Ting[11] ; Liang Aibin[12] ; Gu Runxia[1] ; Ren Jienan[13] ; Feng Yi[13] ; Jin Wei[13] ; Zhou Yan[13] ; Deng Yiping[13] ; Wang Jianxiang[14,15] ;
机构： [1]State Key Laboratory of Experimental Hematology, National Clinical Research Center of Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, China. [2]Juventas Cell Therapy Ltd., Tianjin, China. [3]The First Affiliated Hospital of Zhengzhou University, China. [4]Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, China. [5]Department of Hematology, Nanfang Hospital, Southern Medical University, China. [6]Department of Hematology, The Affiliated Hospital of Xuzhou Medical University, China. [7]Medical Center of Hematology, Xinqiao Hospital, State Key Laboratory of Trauma, Burn and Combined Injury, Army Medical University, China. [8]Beijing Gobroad Boren Hospital, Beijing, China. [9]Department of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, China. [10]Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [11]Department of Hematology, West China Hospital, Sichuan University, China. [12]Department of Hematology, Tongji Hospital of Tongji University, China. [13]Juventas Cell Therapy Ltd., Beijing, China. [14]State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin 300020, China [15]Tianjin Institutes of Health Science, Tianjin 301600, China., Tianjin, China.
出处：
DOI： 10.1182/bloodadvances.2024014182
ISSN：

关键词： Inaticabtagene Autoleucel CNCT19 leukemia Trial CAR-T therapy

摘要：
Prior to November 2023, CD19 CAR-T therapies had not been approved in China for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), leaving a significant unmet need. In response, Inaticabtagene Autoleucel (Inati-cel), a novel CD19 CAR-T therapy with a distinct scFv (HI19α), was developed and showed promising efficacy in preliminary clinical research. We conducted a phase 2, single-arm, multicenter study of Inati-cel in adult CD19+ r/r B-ALL in China. The primary endpoint was the overall remission rate (ORR) at the end of Month 3. Forty-eight patients who underwent Inati-cel infusion were evaluated for both efficacy and safety. Among them, thirty-four patients achieved and maintained remission beyond 3 months, with 3-month ORR of 70.8% (95%CI, 55.9-83.1). The best ORR was 85.4% with all responders reaching minimal residual disease (MRD) negativity. With median follow-up of 23.7 months, the median DOR was 20.7 months (95%CI, 6.4-not reached), and the median OS was not reached (95%CI, 13.0 months-not reached). Additionally, grade 3 or higher cytokine release syndrome and neurologic events occurred in 12.5% and 6.2% of patients respectively. The 2-year follow-up data suggest that Inati-cel demonstrated an encouraging and durable responses with manageable safety profiles in r/r B-ALL. Based on the data from this pivotal trial, Inati-cel was approved as the first CAR-T therapy for adult r/r B-ALL in China and underscores its potential therapeutic benefits for this patient population. NCT04684147.Copyright © 2024 American Society of Hematology.

语种：
外文
PubmedID：
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出版当年[2024]版：
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最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 血液学
第一作者：
第一作者机构： [1]State Key Laboratory of Experimental Hematology, National Clinical Research Center of Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, China.
共同第一作者：
通讯作者：
通讯机构： [14]State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin 300020, China [15]Tianjin Institutes of Health Science, Tianjin 301600, China., Tianjin, China.
推荐引用方式(GB/T 7714)：
Wang Ying,Lv Lulu,Song Yongping,et al.Inaticabtagene Autoleucel (CNCT19) in adult relapsed or refractory B-cell acute lymphoblastic leukemia[J].Blood Advances.2024,doi:10.1182/bloodadvances.2024014182.
APA：
Wang Ying,Lv Lulu,Song Yongping,Wei Xudong,Zhou Hongsheng...&Wang Jianxiang.(2024).Inaticabtagene Autoleucel (CNCT19) in adult relapsed or refractory B-cell acute lymphoblastic leukemia.Blood Advances,,
MLA：
Wang Ying,et al."Inaticabtagene Autoleucel (CNCT19) in adult relapsed or refractory B-cell acute lymphoblastic leukemia".Blood Advances .(2024)

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