Delving into the Latest Updates on Anti-CD7 CAR-T cell therapy (Yake Biotechnology) with Synapse

Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.

Start Date18 Feb 2024

Sponsor / Collaborator

Shanghai Yake Biotechnology Co., Ltd

NCT05827835 / RecruitingPhase 2IIT

A Study to Evaluate the Efficacy and Safety of CD7CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases

Start Date30 Apr 2023

Sponsor / Collaborator

Zhejiang University

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100 Clinical Results associated with Anti-CD7 CAR-T cell therapy (Yake Biotechnology)

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100 Translational Medicine associated with Anti-CD7 CAR-T cell therapy (Yake Biotechnology)

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100 Patents (Medical) associated with Anti-CD7 CAR-T cell therapy (Yake Biotechnology)

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Literatures (Medical) associated with Anti-CD7 CAR-T cell therapy (Yake Biotechnology)

01 Dec 2023·Human Gene Therapy

Universal Anti-CD7 CAR-T Cells Targeting T-ALL and Functional Analysis of CD7 Antigen on T/CAR-T Cells

Article

Author: Qiu, Shaowei ; Gu, Runxia ; Xie, Leling ; Xu, Yingxi ; Xing, Haiyan ; Tang, Kejing ; Rao, Qing ; Yang, Xue ; Tian, Zheng ; Wang, Jianxiang ; Mou, Junli ; Wang, Min ; Wang, Ying

Chimeric antigen receptor T (CAR-T) cell therapy initiates new methods and turns the scale of clinical treatment on relapsed/refractory acute T lymphoblastic leukemia (T-ALL). In this study, we generated the second-generation CD7-targeting CAR-T cells with a new antigen-binding single-chain variable fragment sequence and made it universal via CRISPR-based knockout of TRAC and CD7 genes (termed UCAR-T). The CD7 UCAR-T cells can efficiently proliferate and lyse T-ALL tumor cell in vitro, along with prominent proinflammatory cytokines secretion. A Jurkat-based xenograft mouse model further verified the superior cytotoxicity of the UCAR-T cells in vivo. During the UCAR-T construction, we observed a CD4/CD8 ratio shift among CD7^-/- T/CAR-T cells, which motivated us to further analyze the effects of CD7 antigen on T/CAR-T cells. We sorted out CD7^+/- T or anti-CD19 CAR-T cells after partially CD7 knockout and performed functional, phenotypic detection, as well as translational analysis. CD7^-/- CAR-T cells tended to be CD8 negative and showed slightly better cytotoxicity at long-term assay. RNA-seq further confirmed an elevation of activated CD4 memory cell subpopulation. However, limited distinction on crucial regulatory genes and pathways was revealed, suggesting the safety and feasibility of UCAR-T application as well as the potential translational rather than transcriptional regulation of CD7 antigen.

01 Dec 2023·American Journal of Hematology

Analysis of 60 patients with relapsed or refractory T‐cell acute lymphoblastic leukemia and T‐cell lymphoblastic lymphoma treated with CD7‐targeted chimeric antigen receptor‐T cell therapy

Article

Author: Jin, David ; Zhao, Yan-Li ; Qiu, Liyuan ; Lu, Peihua ; Zhang, Xian ; Lu, Yue ; Li, Jianqiang ; Li, Jingjing ; Yang, Junfang ; Zhang, Jianping

AbstractWhile the use of chimeric antigen receptor‐T (CAR‐T) therapy for T‐cell malignancies is in the early stage of clinical trials, it exhibits substantial potential to offer long‐term remission for patients with refractory/relapsed (R/R) T‐cell malignancies. In our phase I/II clinical trials, 65 pediatric and adult patients with R/R T‐cell acute lymphoblastic leukemia and lymphoblastic lymphoma (T‐ALL/LBL) were enrolled (NCT04572308 and NCT04916860). Of these, 60 participants (T‐ALL 35, T‐LBL 25) received a single dose of naturally selected anti‐CD7 CAR (NS7CAR) T cells at three levels: a low dose (5 × 105/kg), a medium dose (1 to 1.5 × 106/kg), and a high dose (2 × 106/kg). On day 28, 94.4% of patients achieved deep complete remission (CR) in bone marrow. Among the 32 patients with extramedullary disease, 78.1% showed response, with 56.3% in CR and 21.9% in partial remission. The 2‐year overall survival and progression‐free survival (PFS) were 63.5% (95% CI 47.7–79.4) and 53.7% (95% CI, 38.9–68.6), with no difference between pediatric and adult patients. PFS was significantly higher among the 37 CR patients who proceeded with consolidation transplant than the 10 patients who did not with 1‐year PFS 67.2% (95% CI 51.9–82.4) versus 15.0% (95% CI 0–40.2), p < .0001. Of the 10 CR patients without transplants, eight relapsed, while two sustained CR on day 128, and day 180, respectively. Cytokine release syndrome occurred in 91.7% of patients (grade 1/2 in 80.0%, grade 3/4 in 11.7%) and 5% of patients had neurotoxicity. NS7CAR‐T therapy is effective in treating R/R T‐ALL/LBL patients with promising PFS while maintaining a manageable safety profile.

25 Apr 2023·Blood cancer journal

Allogenic and autologous anti-CD7 CAR-T cell therapies in relapsed or refractory T-cell malignancies.

Article

Author: Xu, Jia ; Wang, Xindi ; Li, Chenggong ; Wu, Di ; Huang, Zhongpei ; Tang, Lu ; Wu, Zhuolin ; Zhang, Yinqiang ; Kang, Yun ; Mei, Heng ; Zhang, Yanlei ; Hu, Yu ; Chang, Alex H ; Du, Mengyi ; Luo, Wenjing ; Jiang, Huiwen

Chimeric antigen receptor-T (CAR-T) therapy remains to be investigated in T-cell malignancies. CD7 is an ideal target for T-cell malignancies but is also expressed on normal T cells, which may cause CAR-T cell fratricide. Donor-derived anti-CD7 CAR-T cells using endoplasmic reticulum retention have shown efficacy in patients with T-cell acute lymphoblastic leukemia (ALL). Here we launched a phase I trial to explore differences between autologous and allogeneic anti-CD7 CAR-T therapies in T-cell ALL and lymphoma. Ten patients were treated and 5 received autologous CAR-T therapies. No dose-limiting toxicity or neurotoxicity was observed. Grade 1-2 cytokine release syndrome occurred in 7 patients, and grade 3 in 1 patient. Grade 1-2 graft-versus-host diseases were observed in 2 patients. Seven patients had bone marrow infiltration, and 100% of them achieved complete remission with negative minimal residual disease within one month. Two-fifths of patients achieved extramedullary or extranodular remission. The median follow-up was 6 (range, 2.7-14) months and bridging transplantation was not administrated. Patients treated with allogeneic CAR-T cells had higher remission rate, less recurrence and more durable CAR-T survival than those receiving autologous products. Allogeneic CAR-T cells appeared to be a better option for patients with T-cell malignancies.

100 Deals associated with Anti-CD7 CAR-T cell therapy (Yake Biotechnology)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
acute leukemia	Phase 2	CN	Shanghai Yake Biotechnology Co., Ltd	18 Feb 2024
CD7 positive Hematologic Neoplasms	Phase 2	CN	Zhejiang University	30 Apr 2023
CD7 positive Hematologic Neoplasms	Phase 2	CN	Shanghai Yake Biotechnology Co., Ltd	30 Apr 2023
Crohn Disease	Phase 1	CN	Shanghai Yake Biotechnology Co., Ltd	28 Feb 2022
Crohn Disease	Phase 1	CN	Zhejiang University	28 Feb 2022
Acute Myeloid Leukemia	Phase 1	CN	Shanghai Yake Biotechnology Co., Ltd	01 Apr 2021
CD7 Positive Neoplasms	Phase 1	CN	Shanghai Yake Biotechnology Co., Ltd	01 Apr 2021
CD7 Positive T-Cell Leukemia	Phase 1	CN	Shanghai Yake Biotechnology Co., Ltd	01 Apr 2021
T-Cell Lymphoma	Phase 1	CN	Shanghai Yake Biotechnology Co., Ltd	01 Apr 2021
T-Cell Prolymphocytic Leukemia	Preclinical	CN	Shanghai Yake Biotechnology Co., Ltd	15 Apr 2021

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04599556 (EBMT2023) Manual	Phase 1/2	CD7 Positive Acute Myeloid Leukemia CD7	9	anti-CD7 CAR-T cells	(btwpcflksz) = Adverse events including cytokine release syndrome grade 1-2 occurred in all patients (n=9) and cytopenia grade 3-4 in 100% (n=9), neurotoxicity grade 1-2 in 11.1% (n=1), and viral activation grade 1-2 in 22.2% (n=2) esdlarcdqv (jkyqsafcqr )	Positive	26 Apr 2023
NCT04823091 (EHA2022) Manual	Phase 1	T-Cell Leukemia	10	Anti-CD7 CAR-T cell therapy (Yake Biotechnology)	(wrkbrkywjm) = cbnazykqsd lroyaewzbw (bapacchqnj ) View more	Positive	12 May 2022