Autologous CD7-CAR T Cells(Beijing Boren Hospital)(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，T细胞急性淋巴细胞白血病/淋巴瘤_专利_临床

概要

基本信息

药物类型

自体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T细胞急性淋巴细胞白血病/淋巴瘤+ [1]

非在研适应症-

原研机构

北京高博博仁医院有限公司

在研机构

北京高博博仁医院有限公司

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

5

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

NCT04840875 / Completed临床1期

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2021-09-14

申办/合作机构

北京高博博仁医院有限公司

NCT04689659 / Recruiting临床2期

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

北京高博博仁医院有限公司

ChiCTR2100042807 / Recruiting早期临床1期

A single-center, open, non-randomized, single-arm clinical trial of autologous CD7-CAR T cells in the treatment of refractory/relapsed CD7-positive lymphoma

开始日期2021-01-26

申办/合作机构

北京高博博仁医院有限公司

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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22

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

2024-07-04·New England Journal of Medicine

CD7 CAR T-Cell Therapy and Allogeneic HSCT

Letter

作者: Yu, Changlin ; Cai, Bo ; Guo, Mei

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.).

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

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
成人T细胞白血病/淋巴瘤	临床2期	中国	北京高博博仁医院有限公司	2021-02-01
难治性T淋巴细胞淋巴瘤	临床2期	中国	北京高博博仁医院有限公司	2021-02-01
T细胞急性淋巴细胞白血病/淋巴瘤	临床1期	中国	北京高博博仁医院有限公司	2021-09-14
T细胞淋巴瘤	临床1期	中国	北京高博博仁医院有限公司	2021-09-14

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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	(鏇淵衊憲襯衊製夢膚願) = 壓觸膚蓋鑰獵鬱憲鬱築積構糧製鏇鏇餘繭繭範 (觸鏇蓋憲網襯獵蓋齋夢 ) 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	(獵餘醖醖獵鏇鏇膚範膚) = 積糧網鹹網簾築選衊鏇遞廠顧製築觸醖簾憲襯 (顧廠憲艱襯襯夢觸顧願 ) 更多	积极	2022-06-02