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，复发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

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淋巴细胞淋巴瘤复发性急性淋巴细胞白血病+ [3]

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

7

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

NCT06316427 / Recruiting临床1/2期

Autologous and Donor-derived CD7 CAR T-cell Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma: a Single-center, Open-label, Phase Ⅰ/Ⅱ Clinical Trial

This is a single-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled.

开始日期2024-03-22

申办/合作机构

北京高博博仁医院有限公司

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

ChiCTR2100045863 / Recruiting临床1期

A phase I clinical study of donor CD7 CART cells in the treatment of refractory and relapsed T lymphoblastic lymphoma in children and adolescents

开始日期2021-04-30

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: Guo, Mei ; Cai, Bo ; Yu, Changlin

2024-05-01·Pediatric transplantation

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

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

Abstract:

Background:

Refractory/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 presentation:

An 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.

Conclusion:

In 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·The New England journal of medicine

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

Article

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

BACKGROUND:

Patients 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.

METHODS:

We 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.

RESULTS:

After 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).

CONCLUSIONS:

Our 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
复发性急性淋巴细胞白血病	临床2期	中国	北京高博博仁医院有限公司	2024-03-22
T细胞急性淋巴细胞白血病复发	临床2期	中国	北京高博博仁医院有限公司	2024-03-22
T细胞急性淋巴细胞白血病/淋巴瘤	临床2期	中国	北京高博博仁医院有限公司	2024-03-22
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


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	積遞鏇夢製觸構窪觸獵(糧衊網願鏇獵廠齋鬱膚) = 憲選夢獵鏇鬱顧觸願廠襯餘構鬱餘築廠觸遞憲 (鹹鏇範製夢糧糧蓋築積 ) 更多	积极	2022-06-02
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	選築膚選獵蓋遞願膚壓(鑰醖齋壓窪膚顧網憲鏇) = 糧艱壓壓襯繭壓醖壓壓淵遞範範構鹹鹹鹹積網 (醖願襯膚夢餘餘獵齋餘 ) 更多	积极	2022-06-02