(Autologous CD7-CAR T Cells(Beijing Boren Hospital)) - 药物靶点：CD7_在研适应症：成人T细胞白血病/淋巴瘤，难治性T淋巴细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

自体型CAR-T

别名-

靶点

CD7

作用机制

CD7调节剂(T细胞抗原CD7调节剂)

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

成人T细胞白血病/淋巴瘤难治性T淋巴细胞淋巴瘤

非在研适应症-

原研机构

Beijing Boren Hospital

在研机构

Beijing Boren Hospital

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-

关联

5

项与 Autologous CD7-CAR T Cells(Beijing Boren Hospital) 相关的临床试验

NCT04840875 / Recruiting临床1期IIT

Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma

This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.

开始日期2021-04-20

申办/合作机构

Beijing Boren Hospital

NCT04689659 / Recruiting临床2期IIT

Multi-centers, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Donor-Derived CD7 CAR T Cells in Subjects With Relapsed or Refractory T-cell Leukemia/Lymphoma

This is a multi-centers, single-arm, open label, Phase 2 clinical trial to evaluate the efficacy and safety of CD7 CAR T cells in subjects with relapsed or refractory T-cell leukemia/lymphoma. Seventy subjects will be enrolled. CD7 CAR T cells will be given once intravenously at one dose (1×106, with an allowance of ± 20%) in patients received previous HSCT donor-derived CAR T cells. Patients who received fresh donor derived CD7 CAR T cells were given initial dose of 1×106, with an allowance of ± 20%. The dose levels may be adjusted during the study based on the specific number of cells on the day of fresh CAR T cells infusion, due to at this time all the patients have completed lymphodepleting, so we adopt the allowance of ±20% for each group of absolute infusion cells. And patients who were lower than the designed dose group were also given infusion, but they will be either assigned to the lower dose group or exclude from safety analysis of designed dose group.

开始日期2021-02-01

申办/合作机构

Beijing Boren Hospital

ChiCTR2000034762 / Recruiting早期临床1期IIT

A single-center, open, non-randomized, single-arm clinical trial of donor CD7-CAR T cells in the treatment of refractory/relapsed acute T lymphoblastic leukemia

开始日期2020-07-17

申办/合作机构

Beijing Boren Hospital

100 项与 Autologous CD7-CAR T Cells(Beijing Boren Hospital) 相关的临床结果

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100 项与 Autologous CD7-CAR T Cells(Beijing Boren Hospital) 相关的转化医学

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100 项与 Autologous CD7-CAR T Cells(Beijing Boren Hospital) 相关的专利（医药）

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20

项与 Autologous CD7-CAR T Cells(Beijing Boren Hospital) 相关的文献（医药）

2024-05-01·Pediatric Transplantation

CD7 CAR T bridging to allo‐HSCT in R/R T‐ALL: A case report

作者: Ren, Xiaotong ; Wu, Tong ; Chen, Xiuqiong ; Fanqiao, Meng ; Li, Lijuan

AbstractBackgroundRefractory/relapsed T‐cell acute lymphoblastic leukemia (R/R T‐ALL) is a hematological malignancy with a poor prognosis. The current treatment strategy has not benefited most patients, and the treatment methods are still being explored.Case presentationAn 8‐year‐old boy with R/R T‐ALL achieved CR after multiple chemotherapies, followed by the first allo‐HSCT. Unfortunately, 1 year and 3 months later, he relapsed. After recurrence, the patient underwent multiple chemotherapies, but the NOTCH1 gene and MRD were still positive. FCM and immunohistochemistry revealed abnormally high expression of CD7, so we considered bridging the second allo‐HSCT after CD7 CAR T‐cells treatment. The patient has low toxic and side effects and is still in CR, findings from this case report have more important therapeutic significance for R/R T‐ALL.ConclusionIn conclusion, CD7 CAR T‐cells bridging to allo‐HSCT is a safe and effective approach for R/R T‐ALL, resulting in durable CR and longer survival.

2024-04-25·New England Journal of Medicine

Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis

Article

作者: Jin, Chunxiang ; Wei, Guoqing ; Zu, Cheng ; Yang, Tingting ; Feng, Youqin ; Kong, Delin ; Xu, Huijun ; Chen, Rongrong ; Huang, He ; Yu, Yunxian ; Cui, Qu ; Xiao, Pingnan ; Cui, Jiazhen ; Hong, Ruimin ; Chang, Alex H ; Guo, Hongshan ; Wang, Dongrui ; Zhang, Mingming ; Jing, Ruirui ; Zhao, Houli ; Huang, Simao ; Liang, Bin ; Gu, Tianning ; Ren, Jiangtao ; Hu, Yongxian ; Feng, Jingjing ; Mo, Zhuomao ; Fu, Shan ; Yuan, Xiaolin

BACKGROUNDPatients with relapsed or refractory hematologic cancers have a poor prognosis. Chimeric antigen receptor (CAR) T-cell therapy as a bridge to allogeneic hematopoietic stem-cell transplantation (HSCT) has the potential for long-term tumor elimination. However, pre-HSCT myeloablation and graft-versus-host disease (GVHD) prophylaxis agents have toxic effects and could eradicate residual CAR T cells and compromise antitumor effects. Whether the integration of CAR T-cell therapy and allogeneic HSCT can preserve CAR T-cell function and improve tumor control is unclear.METHODSWe tested a novel "all-in-one" strategy consisting of sequential CD7 CAR T-cell therapy and haploidentical HSCT in 10 patients with relapsed or refractory CD7-positive leukemia or lymphoma. After CAR T-cell therapy led to complete remission with incomplete hematologic recovery, patients received haploidentical HSCT without pharmacologic myeloablation or GVHD prophylaxis drugs. Toxic effects and efficacy were closely monitored.RESULTSAfter CAR T-cell therapy, all 10 patients had complete remission with incomplete hematologic recovery and grade 4 pancytopenia. After haploidentical HSCT, 1 patient died on day 13 of septic shock and encephalitis, 8 patients had full donor chimerism, and 1 patient had autologous hematopoiesis. Three patients had grade 2 HSCT-associated acute GVHD. The median follow-up was 15.1 months (range, 3.1 to 24.0) after CAR T-cell therapy. Six patients remained in minimal residual disease-negative complete remission, 2 had a relapse of CD7-negative leukemia, and 1 died of septic shock at 3.7 months. The estimated 1-year overall survival was 68% (95% confidence interval [CI], 43 to 100), and the estimated 1-year disease-free survival was 54% (95% CI, 29 to 100).CONCLUSIONSOur findings suggest that sequential CD7 CAR T-cell therapy and haploidentical HSCT is safe and effective, with remission and serious but reversible adverse events. This strategy offers a feasible approach for patients with CD7-positive tumors who are ineligible for conventional allogeneic HSCT. (Funded by the National Natural Science Foundation of China and the Key Project of Science and Technology Department of Zhejiang Province; ClinicalTrials.gov numbers, NCT04599556 and NCT04538599.).

2023-10-14·Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi

[Efficacy and safety of fourth-generation CD19 CAR-T expressing IL7 and CCL19 along with PD-1 monoclonal antibody for relapsed or refractory large B-cell lymphoma].

Article

作者: Chen, P P ; Yu, T ; Yuan, X G ; Zhao, A Q ; Qian, W B ; Lei, W ; Gao, J M ; Liu, H

目的： 系统性研究表达白细胞介素7（IL7）和趋化因子C-C基序配体19（CCL19）的第四代靶向CD19嵌合抗原受体T细胞（CD19 CAR-T）联合PD-1单抗治疗复发难治大B细胞淋巴瘤的疗效及安全性。 方法： 应用自体7×19 CAR-T联合替雷利珠单抗治疗11例复发难治大B细胞淋巴瘤患者，评估其疗效及不良反应。 结果： 11例入组患者均完成自体7×19 CAR-T的制备和回输，9例患者完成预定的6次替雷利珠单抗治疗，1例患者完成4次，1例患者完成1次。5例（45.5%）达完全缓解，3例（27.3%）达部分缓解，客观缓解率72.7%。2例评估为疾病进展，1例在回输后2个月因疾病不能控制而死亡。中位随访时间31（2~34）个月，中位总生存时间未达到，中位无进展生存时间为28（1~34）个月，2例部分缓解患者分别在随访第9个月和第12个月进一步获得完全缓解，故最佳完全缓解率为63.6%。细胞因子释放综合征和免疫效应细胞相关神经毒性综合征均可控，未见免疫相关不良反应发生。 结论： 自体7×19 CAR-T联合替雷利珠单抗治疗复发难治大B细胞淋巴瘤取得较好疗效，且不良反应可控。.

100 项与 Autologous CD7-CAR T Cells(Beijing Boren Hospital) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
成人T细胞白血病/淋巴瘤	临床2期	中国	Beijing Boren Hospital	2021-02-01
难治性T淋巴细胞淋巴瘤	临床2期	中国	Beijing Boren Hospital	2021-02-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04840875 (ASCO2022) 人工标引	临床1期	T细胞急性淋巴细胞白血病/淋巴瘤	5	Autologous CD7-targeted CAR T-cell therapy	(鬱艱鹹繭醖範鹹襯艱製) = 範簾範襯膚鹽夢構積鏇鏇醖餘鏇顧範獵鏇壓襯 (醖膚艱積衊鹹齋繭壓願 ) 更多	积极	2022-06-02
ChiCTR2000034762 (ASCO2022) 人工标引	临床1期	前体T淋巴细胞白血病淋巴瘤	20	donor-derived CD7 CAR T cells	(壓衊憲鹹選齋齋壓製夢) = 齋醖築夢製獵簾鹹鏇簾糧遞壓壓艱餘廠膚繭獵 (鹽壓繭壓簾鬱糧淵膚鬱 ) 更多	积极	2022-06-02