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更新于：2026-09-14
Metabolically Armed CD19 CAR-T cells(Leman Biotech )
更新于：2026-09-14
概要
基本信息
药物类型 自体CAR-T |
别名 IL-10 CD19 CAR-T(Leman)、META10-19 |
靶点 |
作用方式 调节剂 |
作用机制 CD19调节剂(B淋巴细胞抗原CD19调节剂)、免疫细胞毒性、T淋巴细胞替代物 |
在研适应症 |
非在研适应症 |
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段早期临床1期 |
首次获批日期- |
最高研发阶段(中国)早期临床1期 |
特殊审评- |
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关联
7
项与 Metabolically Armed CD19 CAR-T cells(Leman Biotech ) 相关的临床试验NCT06711146
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research
NCT06716164
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r B-NHL Clinical Research
NCT06393335
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research
100 项与 Metabolically Armed CD19 CAR-T cells(Leman Biotech ) 相关的临床结果
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100 项与 Metabolically Armed CD19 CAR-T cells(Leman Biotech ) 相关的转化医学
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100 项与 Metabolically Armed CD19 CAR-T cells(Leman Biotech ) 相关的专利（医药）
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2
项与 Metabolically Armed CD19 CAR-T cells(Leman Biotech ) 相关的文献（医药）2025-11-01Lancet Haematology
IL-10-expressing, anti-CD19 CAR T cells for patients with relapsed or refractory B-cell acute lymphoblastic leukaemia: an open-label, single-arm, phase 1 study
Article
作者: Li, Youjia ; Xue, Lei ; Hu, Yongxian ; Wang, Xingbing ; Li, Hui ; Huang, He ; Xu, Hui ; Liu, Chongling ; Chen, Qian ; Gao, Min ; Guo, Yugang ; Xu, Qianwen ; Tang, Li ; Zhang, Xuhan ; Sathiyanadan, Karthik ; Ren, Jingjing
BACKGROUND:
Although chimeric antigen receptor (CAR) T-cell therapy has improved clinical outcomes for patients with relapsed or refractory B-cell acute lymphoblastic leukaemia, treatment resistance and relapse after remission driven by CAR T-cell dysfunction remain significant clinical challenges. To mitigate this limitation, we developed anti-CD19 CAR T cells expressing IL-10 (META 10-19) and aimed to assess their safety and activity in this patient group.
METHODS:
We conducted an open-label, single-arm, phase 1 study at the First Affiliated Hospital of University of Science and Technology of China, Hefei, China. Patients aged 3-70 years with relapsed or refractory B-cell acute lymphoblastic leukaemia diagnosed according to the 5th edition of WHO's Classification of Haematolymphoid Tumours and an Eastern Cooperative Oncology Group performance status score of 0-1 were eligible for inclusion. Lymphodepletion was achieved by use of intravenous fludarabine (25-30 mg/m2 per day) and intravenous cyclophosphamide (250-300 mg/m2 per day) from day -5 to -3. META 10-19 was administered intravenously in a single infusion of 0·1 × 106 or 0·2 × 106 CAR T cells per kg. The primary endpoints were safety, assessed by dose-limiting toxicity, immune effector cell-associated toxicity, and other treatment-related adverse events; and activity, assessed by clinical response rate and survival. Safety and activity were analysed in all eligible patients who received META 10-19 infusion. This study is registered with ClinicalTrials.gov, NCT05747157, and has been completed.
FINDINGS:
Between May 16, 2023, and July 29, 2024, 15 patients were enrolled and underwent whole-blood collection. 12 patients (median age 48 years [IQR 33-53]) received META 10-19 infusion and were included in the analyses, of whom all patients were Chinese, seven (58%) were men, and five (42%) were women. Median follow-up was 12·5 months (IQR 7·4-15·6). The most common grade 3 or worse adverse events were haematological toxicities in all 12 (100%) patients, including neutropenia (12 [100%]), anaemia (ten [83%]), and thrombocytopenia (ten [83%]). 11 (92%) patients had grade 1 or 2 cytokine release syndrome; no patients experienced immune effector cell-associated neurotoxicity syndrome. No treatment-related deaths were reported. Overall response at 1 month was observed in all 12 (100%) patients, with complete response in four (33%) patients, complete response with incomplete or partial haematological recovery in five (42%) patients, and morphological leukaemia-free state in three (25%) patients.
INTERPRETATION:
META 10-19 showed a manageable safety profile and promising antileukaemic activity in patients with relapsed or refractory B-cell acute lymphoblastic leukaemia at low doses, highlighting that IL-10 engineering is a potential strategy for optimising CAR T-cell therapy in this patient group.
FUNDING:
Centre for Leading Medicine and Advanced Technologies of Institute of Health and Medicine, Hefei Comprehensive National Science Center, National Natural Science Foundation of China, Shenzhen Science and Technology Program, and Hefei Municipal Natural Science Foundation.
TRANSLATION:
For the Chinese translation of the abstract see Supplementary Materials section.
JAMA Oncology
Ultralow-Dose Interleukin 10–Expressing Chimeric Antigen Receptor T Cells in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Article
作者: Hong, Ruimin ; Feng, Jingjing ; Bai, Daojun ; Dong, Yetian ; Guo, Yugang ; Huang, He ; Cui, Jiazhen ; Zhou, Zhan ; Yang, Tinging ; Li, Yiling ; Liu, Chongling ; Fu, Shan ; Zhang, Mingming ; Ren, Jingjing ; Cheng, Baoyun ; Wang, Xingbing ; Huang, Simao ; Zhu, Xunuo ; Hu, Yongxian ; Li, Youjia ; Wei, Guoqing ; Zhao, Duoduo ; Gao, Min ; Wang, Dongrui ; Chen, Qian ; Cui, Yuanbin ; Tang, Li
Importance:
Interleukin (IL)-10 expressing CD19 chimeric antigen receptor (CAR) T cells (META 10-19) have demonstrated encouraging clinical activity in B-cell acute lymphoblastic leukemia, but their safety and efficacy in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) remain unknown.
Objective:
To evaluate the safety and efficacy of META 10-19 in patients with R/R DLBCL.
Design, Setting, and Participants:
This nonrandomized, phase 1 clinical trial was conducted at the First Affiliated Hospital of Zhejiang University School of Medicine. Patients were enrolled from November 16, 2023, to April 7, 2025. The data cutoff date was January 20, 2026. The data analysis was conducted on January 22, 2026. Twenty patients were screened, and 13 received a META 10-19 infusion. The median duration of follow-up was 15.6 (range, 0.7-25.5) months.
Intervention:
Following lymphodepletion with fludarabine and cyclophosphamide, patients received META 10-19 at dose levels of 2 × 10
3
, 5 × 10
3
or 2 × 10
4
CAR T cells/kg.
Main Outcomes and Measures:
The primary end points were adverse events, dose-limiting toxic effects, and objective response rate. The secondary end points included complete remission (CR) and a cellular kinetic of META 10-19.
Results:
Among 13 treated patients (median age, 61 years [range, 35-74 years]; 8 men [61.5%] and 5 women [38.5%]), the objective response rate was 92.3%, including CR in 11 patients (84.6%) and partial remission in 1 patient (7.7%). One patient died before response assessment because of disease-related gastrointestinal complications. Cytokine release syndrome occurred for 12 patients (grade 1: n = 8; grade 2: n = 3; grade 3: n = 1), and immune effector cell–associated neurotoxicity syndrome occurred for 2 patients (grade 1: n = 1; grade 2: n = 1). Robust in vivo CAR T-cell expansion was observed across dose levels, with a median (range) peak expansion of 660.7 (30.7-10 562.3) cells/µL. At data cutoff, 5 patients experienced a maintained CR and 7 experienced disease relapses or progression (2 with CD19 negative relapses).
Conclusions and Relevance:
The results of this nonrandomized clinical trial suggest that ultralow-dose META 10-19 demonstrated promising antitumor activity and a manageable safety profile in patients with R/R DLBCL. Further investigation in larger cohorts is warranted.
Trial Registration:
ClinicalTrials.gov Identifier:
NCT06120166
100 项与 Metabolically Armed CD19 CAR-T cells(Leman Biotech ) 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 系统性红斑狼疮 | 临床1期 | 中国 | 2024-12-24 | |
| B细胞恶性肿瘤 | 临床1期 | 中国 | 2024-05-15 | |
| 三重淋巴瘤 | 临床1期 | 中国 | 2024-05-15 | |
| 复发性弥漫性大B细胞淋巴瘤 | 临床1期 | 中国 | 2023-11-16 | |
| 难治性 B 细胞急性淋巴细胞白血病 | 临床1期 | 中国 | 2023-02-15 | |
| CD19 表达恶性肿瘤 | 临床1期 | 中国 | 2023-02-10 | |
| 弥漫性大B细胞淋巴瘤 | 临床1期 | 中国 | 2023-02-10 | |
| 纵隔大b细胞淋巴瘤 | 临床1期 | 中国 | 2023-02-10 | |
| 骨髓瘤复发 | 临床1期 | 中国 | 2023-02-10 | |
| CD19阳性急性淋巴细胞白血病 | 临床申请批准 | 中国 | 2026-09-10 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 14 | 鏇襯構遞顧糧襯窪願願(廠積鑰繭網顧遞獵齋憲) = neutropenia (100%, 14/14), thrombocytopenia (85.7%, 12/14), and anemia (71.4%, 10/14) 願鹽衊範繭夢齋選壓遞 (顧壓衊觸餘繭廠膚網鑰 ) 更多 | 积极 | 2026-05-29 | |||
临床1期 | 13 | 艱廠鑰鹹醖築簾淵範衊(選築壓積糧簾顧壓糧糧) = 壓窪築構繭壓窪範願衊 獵獵積鬱廠構鏇窪壓齋 (糧願蓋簾鹽蓋艱鏇襯蓋 ) 更多 | 积极 | 2026-03-22 | |||
临床1期 | 10 | 鬱製簾襯鏇衊鹹鑰餘獵(淵築遞壓蓋觸顧顧鹹範) = All participants exhibited robust CAR-T cell expansion (average peak: 2437.4 cells/μL), with an increase in serum IL-10 (average peak: 2056.4 pg/mL). 製廠鏇醖夢積憲廠窪願 (範繭鹽繭襯構壓廠鬱簾 ) 更多 | 积极 | 2025-12-06 | |||
临床1期 | 12 | 廠鬱願構築淵製艱糧鬱(鹽齋醖範鑰醖鏇範遞壓) = The most common grade 3 or worse adverse events were haematological toxicities in all 12 (100%) patients, including neutropenia (12 [100%]), anaemia (ten [83%]), and thrombocytopenia (ten [83%]). 繭繭遞淵獵構蓋餘憲衊 (艱鹽築鬱憲醖獵網糧獵 ) | 积极 | 2025-11-01 | |||
临床1期 | 12 | 觸選選遞餘鏇夢艱窪鑰(衊製醖憲壓蓋窪觸窪衊) = 窪簾鏇鏇蓋願鬱構壓齋 觸範範顧憲齋築鏇願鬱 (窪壓鬱壓選蓋鏇鹹遞築 ) 更多 | 积极 | 2025-10-17 | |||
临床1期 | 6 | 遞積襯製鑰獵糧簾餘廠(憲鏇衊襯襯蓋積壓淵構) = predominantly anemia 築廠廠築蓋餘願夢憲廠 (觸繭簾鹹鹹築願範製簾 ) 更多 | 积极 | 2024-12-07 | |||
早期临床1期 | 20 | 艱鏇遞鹽壓糧廠廠鬱襯(衊製觸製遞膚襯衊鏇衊) = predominantly neutropenia, thrombocytopenia, and anemia, were manageable and effectively resolved with standard and supportive care 蓋餘夢網鏇遞艱鏇鑰窪 (簾衊遞願淵淵鹹壓艱範 ) 更多 | 积极 | 2024-12-07 | |||
临床1期 | 17 | 範齋淵積淵網齋糧膚憲(鹽積蓋窪構夢觸積衊觸) = 蓋鏇鹽廠鏇憲憲構窪餘 鏇蓋願鬱遞鏇簾顧窪簾 (觸餘廠醖築醖鑰壓餘窪 ) 更多 | 积极 | 2024-05-14 |
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