This is a single center, single arm, open-label, dose-escalation clinical study to observe the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics of ESO-T01 injection for treating patients with relapsed/refractory multiple myeloma.

开始日期2025-01-27

申办/合作机构

深圳普瑞金生物药业股份有限公司

NCT06691685

/ Recruiting早期临床1期IIT

A Clinical Study to Evaluate the Safety and Efficacy of ESO-T01 in Treating Relapsed/Refractory Multiple Myeloma.

This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of ESO-T01 for patients with relapsed/refractory multiple myeloma.

开始日期2024-11-18

申办/合作机构

华中科技大学同济医学院附属协和医院

[+1]

NCT06519565

/ Recruiting早期临床1期IIT

Clinical Study on the Safety and Efficacy of PRG-1801 for the Treatment of Recurrent/Refractory Immune Thrombocytopenia (ITP)

This is a single center, open-label, 3+3 dose escalation, early phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of PRG-1801 for patients with relapsed/refractory immune thrombocytopenia (ITP).

开始日期2024-08-20

申办/合作机构

华中科技大学同济医学院附属协和医院

[+1]

100 项与深圳普瑞金生物药业股份有限公司相关的临床结果

登录后查看更多信息

0 项与深圳普瑞金生物药业股份有限公司相关的专利（医药）

登录后查看更多信息

项与深圳普瑞金生物药业股份有限公司相关的文献（医药）

2025-07-01·ANNALS OF THE RHEUMATIC DISEASES

BCMA-targeted CAR T cell therapy can effectively induce disease remission in refractory lupus nephritis

Article

作者: Chen, Yuxue ; Shen, Guifen ; Yu, Yikai ; Ye, Cong ; Cai, Shaozhe ; Wang, Di ; Xiong, Hui ; Zhang, Peiling ; Lin, Shengyan ; Zeng, Zhipeng ; Luo, Xiaofang ; He, Xiaofeng ; Yu, Fei ; Dong, Lingli ; Wang, Bei ; Li, Chunrui ; Zhang, Jishuai ; Zeng, Rui ; Hu, Ziwei ; Ye, Ping ; Zhang, Ziyun ; Chen, Yu ; Bai, Lin

OBJECTIVES:

This study aims to evaluate the safety and efficacy of anti-B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T cells in treating refractory lupus nephritis (LN).

METHODS:

This is an open-label, single-arm clinical trial assessing anti-BCMA CAR T cells in treating refractory LN patients. CAR T cells were infused following lymphodepletion therapy with cyclophosphamide and fludarabine. Patients were regularly followed up, in which clinical assessments were performed and laboratory indices were collected. Repeated renal biopsies and single cell RNA sequencing in certain patients were performed to help evaluate the therapeutic efficacy. The primary endpoints were the safe dosage of single infusion and the occurrence of adverse events, while the secondary endpoints focused on the therapeutic efficacy (eg, changes of Systemic Lupus Erythematosus Disease Activity Index 2000 [SLEDAI-2000]).

RESULTS:

Seven biopsy-confirmed LN patients were enrolled in this study with a median follow-up of 9 months, whose peripheral B cells were effectively eliminated within the first month postinfusions and restored within 3 months except one patient. Hypogammaglobulinemia was frequently observed in this study. Only one case of grade 1 cytokine release syndrome was noted, and no immune effector cell-associated neurotoxicity syndrome or severe infection was reported. SLEDAI-2K scores decreased from a median of 18 (range 10-22) at baseline to 0 (range 0-4) at the last follow-up, and 5 out of 7 patients achieved definition of remission in systemic lupus erythematosus (DORIS) complete remission. Decreased deposition of immune complex, reduced clonal abundance, and alleviated proinflammatory status of peripheral lymphocytes were also observed in repeated renal biopsy and transcriptomic analyses,.

CONCLUSIONS:

Anti-BCMA CAR T therapy can help LN patients inducing and maintaining disease remission status safely and effectively, which indicated the potential feasibility of the BCMA-only-targeting strategy in treating autoimmune diseases with abnormal humoral immune responses through CAR products.

2025-03-08·Protein & Cell

A novel loop-structure-based bispecific CAR that targets CD19 and CD22 with enhanced therapeutic efficacy against B-cell malignancies

Article

作者: Feng, Jia ; Li, Jun ; Zhang, Suping ; Wei, Xiaoyi ; Guo, Qiaoru ; Liu, Ze-Lin ; Li, Shuhong ; Zhang, Hongyu ; Zhao, Lijun ; Cao, Yu J ; Zhang, Ji-Shuai ; Qi, Xuexiu ; Guo, Zhi ; Shi, Yuanyuan ; Shi, Licai

Biomolecules3区 · 生物学

The Application of Nanobody in CAR-T Therapy

3区 · 生物学

ReviewOA

作者: Zhang, Ruining ; Ding, Yijin ; Han, Lu ; Zhang, Bingxiang ; Wu, Xian-Hui ; Song, Zongpei ; Zhang, Jishuai ; Gao, Quanli ; Li, Lin-Lin ; Bao, Chaolemeng

Chimeric antigen receptor (CAR) T therapy represents a form of immune cellular therapy with clinical efficacy and a specific target. A typical chimeric antigen receptor (CAR) construct consists of an antigen binding domain, a transmembrane domain, and a cytoplasmic domain. Nanobodies have been widely applied as the antigen binding domain of CAR-T due to their small size, optimal stability, high affinity, and manufacturing feasibility. The nanobody-based CAR structure has shown a proven function in more than ten different tumor-specific targets. After being transduced in Jurkat cells, natural killer cells, or primary T cells, the resulting nanobody-based CAR-T or CAR-NK cells demonstrate anti-tumor effects both in vitro and in vivo. Interestingly, anti-BCMA CAR-T modulated by a single nanobody or bi-valent nanobody displays comparable clinical effects with that of single-chain variable fragment (scFv)-modulated CAR-T. The application of nanobodies in CAR-T therapy has been well demonstrated from bench to bedside and displays great potential in forming advanced CAR-T for more challenging tasks.

432

项与深圳普瑞金生物药业股份有限公司相关的新闻（医药）

2025-08-13

·同写意

国产首款，如何成就？

上市批准

2025-08-07

·同写意

乐普生物发布2025年度上半年正面盈利预告丨会员动态

抗体药物偶联物申请上市

2025-08-06

·同写意

长风药业吸入小核酸药物研发子公司入驻BioBAY！ | 会员动态

siRNA核酸药物

100 项与深圳普瑞金生物药业股份有限公司相关的药物交易

登录后查看更多信息

100 项与深圳普瑞金生物药业股份有限公司相关的转化医学

登录后查看更多信息

组织架构

使用我们的机构树数据加速您的研究。

或

查看完整样例数据

管线布局

2025年08月25日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

临床前

临床申请批准

早期临床1期

临床2期

其他

登录后查看更多信息

当前项目

药物(靶点)	适应症	全球最高研发状态

靶向BCMA的嵌合抗原受体T细胞(Shenzhen Puruijin Biological Pharmaceutical) ( BCMA )	狼疮性肾炎更多	早期临床1期
PRG-2302	复发性 B 细胞急性淋巴细胞白血病更多	早期临床1期
CD19/BCMA CAR-T (Shenzhen Puruijin Biological Pharma) ( BCMA x CD19 )	狼疮性肾炎更多	早期临床1期
ESO-T01(EsoBiotec) ( BCMA )	难治性多发性骨髓瘤更多	早期临床1期
靶向HLA-A*02:01/NY-ESO-1的TCR-T细胞(Shenzhen Puruijin Biological Pharmaceutical) ( HLA-A2 x NY-ESO-1 )	肉瘤更多	临床申请批准