A Single-arm, Open-label, Single-center Clinical Study: Safety and Efficacy of Anti-CD7 CAR-T in the Treatment of Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma

This study is a single arm, non blind, randomized, single center study aimed at evaluating the safety, pharmacokinetic characteristics, and preliminary efficacy of CD7 CAR-T cell injection in r/r T-ALL/LBL subjects.

Start Date01 May 2023

Sponsor / Collaborator

Guangzhou Bio-gene Technology Co., Ltd.

100 Clinical Results associated with CD7 CAR-T(Guangzhou Bio-gene Technology)

100 Translational Medicine associated with CD7 CAR-T(Guangzhou Bio-gene Technology)

100 Patents (Medical) associated with CD7 CAR-T(Guangzhou Bio-gene Technology)

Literatures (Medical) associated with CD7 CAR-T(Guangzhou Bio-gene Technology)

01 Jun 2024·British Journal of Haematology

A safety and efficacy study of allogeneic haematopoietic stem cell transplantation for refractory and relapsed T‐cell acute lymphoblastic leukaemia/lymphoblastic lymphoma patients who achieved complete remission after autologous CD7 chimeric antigen receptor T‐cell therapy

Article

Author: Lu, Yue ; Liu, De‐yan ; Wei, Zhi‐jie ; Li, Jingjing ; Xiong, Min ; Cao, Xing‐yu ; Zhao, Yan‐li ; Yang, Jun‐fang ; Zhang, Xian ; Sun, Rui‐juan ; Zhang, Jian‐ping ; Lu, Peihua ; Zhou, Jia‐rui

SummaryCD7‐targeted chimeric antigen receptor T‐cell (CAR‐T) therapy has shown promising initial complete remission (CR) rates in patients with refractory or relapsed (r/r) T‐cell acute lymphoblastic leukaemia and lymphoblastic lymphoma (T‐ALL/LBL). To enhance the remission duration, consolidation with allogeneic haematopoietic stem cell transplantation (allo‐HSCT) is considered. Our study delved into the outcomes of 34 patients with r/r T‐ALL/LBL who underwent allo‐HSCT after achieving CR with autologous CD7 CAR‐T therapy. These were compared with 124 consecutive T‐ALL/LBL patients who received allo‐HSCT in CR following chemotherapy. The study revealed that both the CAR‐T and chemotherapy cohorts exhibited comparable 2‐year overall survival (OS) (61.9% [95% CI, 44.1–78.1] vs. 67.6% [95% CI, 57.5–76.9], p = 0.210), leukaemia‐free survival (LFS) (62.3% [95% CI, 44.6–78.4] vs. 62.0% [95% CI, 51.8–71.7], p = 0.548), non‐relapse mortality (NRM) rates (32.0% [95% CI, 19.0–54.0] vs. 25.3% [95% CI, 17.9–35.8], p = 0.288) and relapse incidence rates (8.8% [95% CI, 3.0–26.0] vs. 15.8% [95% CI, 9.8–25.2], p = 0.557). Patients aged ≤14 in the CD7 CAR‐T group achieved high 2‐year OS and LFS rates of 87.5%. Our study indicates that CD7 CAR‐T therapy followed by allo‐HSCT is not only effective and safe for r/r T‐ALL/LBL patients but also on par with the outcomes of those achieving CR through chemotherapy, without increasing NRM.

10 Nov 2023·Leukemia & Lymphoma

Characteristics and therapeutic approaches for patients diagnosed with T-ALL/LBL exhibiting t(8;14)(q24;q11)/TCRA/D:MYC translocation

Article

Author: Ni, Jingbo ; Wei, Zhijie ; Chen, Jiaqi ; Zhang, Yang ; Wang, Fang ; Sun, Ruijuan ; Zhang, Gailing ; Wang, Tong ; Zhang, Xian ; Li, Jingjing ; Lu, Peihua ; Li, Wenqian

T-acute lymphoblastic leukemia/lymphoma (T-ALL/LBL) patients with t(8;14)(q24;q11)/TCRA/D::MYC translocation represent a rare subgroup, with an aggressive course. In our retrospective analysis of 14 patients, all were identified during refractory or relapsed stages (5 primary tumor, 9 relapse). Notably, extramedullary invasion was detected in most patients. Four exhibited STIL::TAL1 translocation, and six demonstrated CDKN2A/B gene loss. The therapeutic outcomes were notably poor for all seven patients who received only chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT); all eventually succumbed to the disease with a median OS of 3 months. In the application of CD7 CAR-T therapy in six patients, five achieved CR. Of the four patients who underwent HSCT following CAR-T therapy, all have remained disease-free. The prognosis for T-ALL/LBL patients with t(8;14) translocation remains bleak, but interventions involving CD7 CAR-T may offer a potential pathway to CR. HSCT following CAR-T could be a viable strategy for long-term survival.

14 Oct 2023·Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi

[Allogeneic hematopoietic stem cell transplantation combined with CD7 CAR-T for the treatment of T lymphoblastic lymphoma: a case report and literature review].

Review

Author: Zhou, H Y ; Sun, Q ; Yan, D M ; Xu, L Y ; Zhou, Y ; Yao, Z H ; Sang, W ; Xu, K L ; Yao, S N ; Zhang, J L ; Zhang, Q ; Wang, X M ; Li, H J

100 Deals associated with CD7 CAR-T(Guangzhou Bio-gene Technology)

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Indication	Highest Phase	Country/Location	Organization	Date
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma	Phase 2	CN	Guangzhou Bio-gene Technology Co., Ltd.	01 May 2023
T-cell Acute Lymphoblastic Leukemia/Lymphoma	Phase 2	CN	Guangzhou Bio-gene Technology Co., Ltd.	01 May 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2021	Not Applicable	Carney Complex CD19 \| CD7	-	CD19 CAR-T	(pomeyicvfy) = rjzojtkxgw ivclniqdms (jpvwvukyut )	-	09 Jun 2021
				CD7 CAR-T	(pomeyicvfy) = wfounbtqjc ivclniqdms (jpvwvukyut )

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