A Dose Escalating Study of CD19/CD22/BCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed/Refractory Multiple Myeloma

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma.

开始日期2024-12-12

申办/合作机构

上海细胞治疗集团股份有限公司

NCT06446128

/ Recruiting早期临床1期

A Dose Escalating Study of CD19/CD22/BCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.

开始日期2024-05-07

申办/合作机构

上海细胞治疗集团股份有限公司

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项与上海细胞治疗集团股份有限公司相关的文献（医药）

2025-08-14·Scientific Reports

Cryopreserved leukapheresis enables scalable and distributed CAR-T manufacturing: a multi-platform comparative study.

Article

作者: Ren, Menglin ; Liu, Tao ; Xu, Zenghui ; Sun, Yan ; Chen, Jiangrui ; Xu, Yuanjian ; Wang, Xiaodie ; Qian, Qijun

Cryopreserved leukapheresis is a scalable source for Chimeric antigen receptor T (CAR-T) manufacturing, yet it remains understudied (18.3% of 349 studies, 2010-2024). Current challenges include that cryopreserved leukapheresis lacks a standardized preparation process and has a low level of automation. Systematic validation of its clinical feasibility and platform compatibility is imperative. We carried out a series of optimizations, including the centrifugation procedure, the proportion of CS10, and the cryopreservation procedure. Eventually, a standardized cryopreserved leukapheresis process was established through a closed automated system. Subsequently, a systematic evaluation of the quality and functionality of cryopreserved leukapheresis was conducted. Results showed that cryopreserved leukapheresis achieved ≥ 90% post-thaw viability, with recovery and phenotypic profiles comparable to peripheral blood mononuclear cells (PBMCs). It exhibited a higher lymphocyte proportion than PBMCs (66.59% vs. 52.20%), correlating with enhanced CAR-T potential. Initial viability (91.0%) was lower than fresh samples (99.0%), but functional recovery post-electroporation and compatibility with both platforms were confirmed. In the non-viral CAR-T, lentiviral CAR-T, and Fast CAR-T platforms, cryopreserved leukapheresis and fresh leukapheresis were comparable in cell viability, expansion, cell phenotype, CAR + cell proportion, and cytotoxicity. This study comprehensively validated cryopreserved leukapheresis as a universal raw material for CAR-T manufacturing, preserving critical quality attributes (T-cell fitness, CAR functionality) without compromising consistency. Decoupling from fresh material logistics improves supply chain resilience. Protocol standardization and large-scale clinical validation remain critical next steps.

2025-08-11·Journal of Translational Medicine

Low-liver-accumulation lipid nanoparticles enhance the efficacy and safety of HPV therapeutic tumor vaccines.

Article

作者: Fang, Yuan ; Guo, Chuanxin ; Yang, Shuyan ; Bai, Xuesen ; Wang, Meng ; Zeng, Jianyao ; Liu, Tao ; Wang, Xiaodie ; Qian, Qijun ; Wang, Pei ; Cai, Xiaoru ; Sun, Yan ; Tian, Zhidan

BACKGROUND:

Lipid nanoparticles (LNPs) hold significant potential in vaccine and cancer therapy, but conventional LNPs often cause hepatotoxicity and reduced efficacy due to liver accumulation.

METHODS:

LNP molecules with varying tail lengths were synthesized in vitro. Transfection efficiency was assessed in vitro via flow cytometry. The BALB/c model was used to evaluate in vivo delivery efficiency of the LNPs. The C57BL/6 mouse model was used to evaluate in vivo anti-tumor pharmacodynamics, along with tumor-infiltrating immune cells and serum inflammatory cytokines. The Sprague Dawley (SD) rat model was used for toxicity testing of the candidate LNP.

RESULTS:

Lipid 7 demonstrated threefold higher mRNA expression efficiency at the injection site while minimizing liver retention. In an HPV tumor model, Lipid 7 achieved tumor suppression comparable to SM-102-based LNP but outperformed in remodeling the tumor microenvironment (dendritic cells: 12.1% vs. 5.1%; natural killer cells: 1.1% vs. 0.5%) and elevating serum immune cytokines (TNF-α, IL-1β, etc., 1.2-1.8-fold higher). Critically, Lipid 7 reduced off-target mRNA accumulation in the heart, liver, spleen, lungs, and kidneys, mitigating hepatotoxicity risks associated with traditional LNPs.

CONCLUSIONS:

By employing a novel, non-patented ionizable lipid design, this work balances delivery efficiency and biosafety, Lipid 7 offers a high-efficacy, low-toxicity therapeutic strategy for HPV-related cancers.

2025-01-01·DRUG DISCOVERY TODAY

Targeting spleen tyrosine kinase (SYK): structure, mechanisms and drug discovery

Review

作者: Lu, Yingying ; Wang, Lilin ; Zhang, Lan ; Zhang, Tongtong ; Guo, Chuanxin ; Zhang, Shuangqian

Spleen tyrosine kinase (SYK) is a crucial non-receptor tyrosine kinase involved in signaling pathways that regulate various cellular processes. It is primarily expressed in hematopoietic cells and myeloid cells, which are crucial for B-cell development, maturation and antibody production, and it is a key therapeutic target for autoimmune and allergic diseases. Overexpression of SYK is also associated with cancer and cardiovascular, cerebrovascular and neurodegenerative diseases, contributing to their initiation and progression. SYK is a promising target for drug development, and several inhibitors have already been reported. This review covers the structure and regulatory pathways of SYK, as well as its links to various diseases. It also highlights key small-molecule SYK inhibitors, their design strategies and their potential therapeutic benefits, aiming to enhance our understanding and aid in the discovery of more-effective SYK inhibitors.

439

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