预约演示
更新于：2026-06-03
Relmacabtagene autoleucel
瑞基奥仑赛
更新于：2026-06-03
概要
基本信息
药物类型 自体CAR-T |
别名 Carteyva、CD19-directed Chimeric Antigen Recepter T Cells、relma-cel + [7] |
靶点 |
作用方式 抑制剂 |
作用机制 CD19抑制剂(B淋巴细胞抗原CD19抑制剂) |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-09-01), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国)、特殊审批 (中国) |
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结构/序列
Sequence Code 1277314396
来源: *****
关联
34
项与 瑞基奥仑赛 相关的临床试验NCT07326371
A Single-Center, Prospective Study Evaluating the Efficacy and Safety of Glofitamab Combined With CAR-T Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma
NCT07198464
A Prospective, Multicenter Clinical Study of Relmacabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation, Orelabrutinib, and Sintilimab for Primary Central Nervous System Lymphoma
NCT07077512
A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.
100 项与 瑞基奥仑赛 相关的临床结果
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100 项与 瑞基奥仑赛 相关的转化医学
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100 项与 瑞基奥仑赛 相关的专利（医药）
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32
项与 瑞基奥仑赛 相关的文献（医药）2026-02-24Blood Advances
Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults
Article
作者: Jin, Zheng-Ming ; Xia, Zhen ; Yang, Hai-Yan ; Xie, Yan ; Tian, Zhao-Zhao ; Zou, De-hui ; Zhou, Ke-Shu ; Cao, Jun-Ning ; Zang, Yi-Bei ; He, Peng-Cheng ; Huang, Hui-Qiang ; Li, Wen-Yu ; Jing, Hong-Mei ; Gu, Yong-En ; Zhu, Jun ; Li, Lan-Fang ; Jin, Jie ; Liang, Ai-Bin ; Zhou, Zi-Song ; Chen, Tong ; Song, Yu-Qin ; Mei, Heng
Abstract:
Relmacabtagene autoleucel (relma-cel), an anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, is approved in China for relapsed/refractory (R/R) large B-cell lymphoma and follicular lymphoma. This phase 2, open-label, single-arm, multicenter study evaluated its efficacy and safety in Chinese patients with heavily pretreated R/R mantle cell lymphoma (MCL). A total of 70 patients with R/R MCL who had received 1 to 9 previous therapies (including anthracycline or bendamustine chemotherapy, anti-CD20 antibodies, and Bruton tyrosine kinase [BTK] inhibitors) were enrolled. Of these, 59 received a single infusion of 100 × 106 CAR-positive T cells following leukapheresis. The primary end point was the objective response rate (ORR) at 3 months after infusion, assessed using the Lugano 2014 criteria. Secondary end points included the duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. At 3 months, the ORR was 71.19% (95% confidence interval [CI], 57.92-82.24) with a complete response rate of 59.32% (95% CI, 45.75-71.93). After a median follow-up of 13.3 months (95% CI, 9.04-18.69), the median DOR was 18.1 months, PFS was 15.5 months, and OS was 19.5 months. Grade 3 or higher treatment-emergent adverse events were common, including neutropenia (76.3%), leukopenia (69.5%), and lymphopenia (47.5%). Severe cytokine release syndrome and neurotoxicity occurred in 6.8% of patients each, and all cases resolved fully. No fatal events were reported. These findings demonstrate that relma-cel offers high response rates, durable remissions, and manageable safety in Chinese patients with R/R MCL. This trial was registered at www.clinicaltrials.gov as #NCT04718883.
2025-12-01JOURNAL OF AUTOIMMUNITY
Preliminary safety and efficacy of relmacabtagene autoleucel (relma-cel) in adults with moderately to severely active systemic lupus erythematosus: a phase I dose-escalation study
Article
作者: Xie, Cuiwei ; Zhang, Chunyan ; Xia, Peng ; Wang, Yiyang ; Yu, Ye ; Lu, Liangjing ; Yang, Shaoying
BACKGROUND:
Chimeric antigen receptor (CAR)-T cell therapy has emerged as a transformative treatment in autoimmune diseases. Relmacabtagene autoleucel (relma-cel) is an autologous, CD19-directed CAR-T cell product developed with a commercial-ready process in China. This study evaluates the safety and efficacy of relma-cel in patients with moderately to severely active systemic lupus erythematosus (SLE).
METHODS:
In this phase I, single-arm, dose escalation study, 8 female patients with moderately to severely active SLE were enrolled. All patients received a single infusion of relma-cel at escalating doses (50 × 106, 75 × 106, or 100 × 106 CAR-T cells) after preconditioning with fludarabine and cyclophosphamide. The primary endpoints included the incidence of dose-limiting toxicities (DLTs), adverse events (AEs), and serious adverse events (SAEs). Secondary endpoints comprised pharmacokinetics, pharmacodynamics, and efficacy, which was evaluated by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), SLE Responder Index (SRI)-4, Lupus Low Disease Activity State (LLDAS), and Definition of Remission in SLE (DORIS) remission criteria.
RESULTS:
No dose-limiting toxicities were reported. Adverse events were manageable, with cytokine release syndrome (CRS) occurred in 7 patients and immune effector cell-associated neurotoxicity syndrome (ICANS) in 1 patient. The mean SLEDAI-2K score of patients decreased from 12.625 at baseline to 3.25 at follow-up. All patients achieved an SRI-4 response at 6 months, with 6 patients meeting LLDAS criteria and 5 achieving DORIS remission. Improvements in renal function and complement levels were also noted.
CONCLUSIONS:
Relma-cel demonstrates a manageable safety profile and promising efficacy in patients with moderately to severely active SLE. A dose of 100 × 106 CAR-T cells was identified as the recommended phase II dose based on clinical response and tolerability.
2025-12-01IMMUNITY
Eomesodermin+ CD4+ T cells are critical for curative immunotherapy outcomes
Article
作者: Gauthier, Jordan ; Sekiguchi, Tomoko ; Gartlan, Kate H ; Atilla, Erden ; Bhise, Shruti S ; Hill, Geoffrey R ; Abe, Kokoro ; Zhang, Ping ; Haeseleer, Françoise ; Nelson, Ethan L ; Legg, Samuel R W ; Minnie, Simone A ; Furlan, Scott N ; Waltner, Olivia G ; Clouston, Andrew D ; Joshi, Tanvi ; Nemychenkov, Nicole S ; Ensbey, Kathleen S ; Liang, Emily C ; Adams, Rachael C ; Koyama, Motoko ; Yeh, Albert C ; Hirayama, Alexandre V
Interleukin 10 (IL-10)-producing CD4+ type-1 regulatory T cells (Tr1) promote immune tolerance during chronic infection, autoimmunity, and transplantation. However, specific Eomesodermin (Eomes)-dependent stages of Tr1 differentiation and function remain unclear. Using preclinical models of bone marrow transplantation (BMT), we demonstrated a Tr1 differentiation trajectory in vivo from Eomes+IL-10- to Eomes+IL-10+ subsets with the acquisition of cytokine, cytolytic, and exhaustion features. The Eomes+CD4+ fraction represented the dominant cytotoxic subset after BMT, mediating graft-versus-leukemia effects while limiting inflammation. In CD19-targeted chimeric antigen receptor (CAR) T cell immunotherapy, Eomes drove the same CD4+ Tr1 phenotype that controlled cytolysis, while mitigating immune toxicity and promoting persistence. In individuals with high-grade B cell lymphomas that had long-term disease control after receiving commercial CD19-targeted CAR T cells, Eomes+ Tr1 cells represented a stable population comprising 40%-80% of the CD4+ CAR T cell population. Hence, Eomes controls both regulatory and cytotoxic programs in CD4+ T cells, essential for curative immunotherapy outcomes.
100 项与 瑞基奥仑赛 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 复发性滤泡性淋巴瘤 | 中国澳门 | 2025-06-04 | |
| 难治性滤泡性淋巴瘤 | 中国澳门 | 2025-06-04 | |
| 复发性套细胞淋巴瘤 | 中国 | 2024-08-20 | |
| 难治性套细胞淋巴瘤 | 中国 | 2024-08-20 | |
| 滤泡性淋巴瘤 | 中国 | 2022-09-30 | |
| 弥漫性大B细胞淋巴瘤 | 中国 | 2021-09-01 | |
| 大B细胞淋巴瘤 | 中国 | 2021-09-01 |
未上市
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 |
|---|---|---|---|---|
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 申请上市 | 中国 | 2025-05-24 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 申请上市 | 中国 | 2025-05-24 | |
| 高级别B细胞淋巴瘤 | 临床3期 | 中国 | 2022-07-08 | |
| 边缘区B细胞淋巴瘤 | 临床3期 | 中国 | 2022-07-08 | |
| 纵隔大b细胞淋巴瘤 | 临床2期 | 中国 | 2024-04-16 | |
| 系统性红斑狼疮 | 临床2期 | 中国 | 2023-12-25 | |
| 原发性中枢神经系统淋巴瘤 | 临床2期 | 中国 | 2023-11-30 | |
| 惰性B细胞非霍奇金淋巴瘤 | 临床2期 | 中国 | 2023-11-03 | |
| 弥漫性硬皮病 | 临床1期 | 中国 | 2024-06-12 | |
| 难治性 B 细胞急性淋巴细胞白血病 | 临床1期 | 中国 | 2022-05-11 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | - | 願鹽齋壓窪醖夢鹹願觸(遞淵膚壓製壓願衊願廠) = 膚齋餘願遞獵淵膚簾窪 餘選範網蓋鬱築膚遞積 (製膚醖憲繭糧顧觸窪構 ) 更多 | 积极 | 2025-10-09 | |||
临床2期 | 70 | 衊簾憲蓋鬱鹹獵簾淵壓(夢觸壓糧簾膚築積願糧) = 窪網衊鬱顧淵選觸廠積 鹽積壓觸鏇遞蓋鑰願獵 (糧鏇夢遞鬱鹹糧築簾窪, 57.92 ~ 82.24) 更多 | 积极 | 2025-08-14 | |||
临床2期 | 53 | 壓衊艱夢餘齋鏇觸窪壓(鹽獵鑰糧襯顧壓夢鑰觸) = 築構築餘構觸艱衊簾鹽 願選網蓋鬱艱鑰製築選 (餘膚鑰窪鑰壓齋顧獵淵, 67.4 ~ 91.1) 更多 | 积极 | 2025-05-14 | |||
(Historical control group) | 網築遞鏇醖夢廠簾餘構(醖簾鬱獵襯餘壓繭膚糧) = 憲獵網窪選獵糧鹹醖淵 糧淵築網襯遞夢夢選襯 (願鏇廠衊積壓製積範製 ) | ||||||
临床1期 | 8 | 廠壓鹽鬱窪選願蓋夢範(遞網鑰遞顧鏇積艱簾窪) = 糧觸繭艱鹹鹽遞選範壓 蓋鹽鹽膚憲鬱艱齋範窪 (膚範憲築壓選鏇簾鬱齋 ) 更多 | 积极 | 2025-05-01 | |||
临床1期 | 3 | 廠餘鹹鬱衊壓廠構壓簾(膚鹹蓋壓衊壓構築積鏇) = 壓鬱襯願構築襯壓遞觸 淵鹽獵淵壓廠艱鑰蓋憲 (膚壓衊膚衊艱膚獵夢淵 ) 更多 | 积极 | 2024-06-12 | |||
临床2期 | 58 | relma-cel 100 × 106 CAR+ T cells | 範構淵醖膚選夢獵膚構(顧範餘鏇製製顧選窪獵) = 獵壓襯觸膚鏇窪構艱衊 糧製鹹繭觸鏇製襯餘鏇 (蓋窪觸觸餘積襯遞範壓 ) 更多 | 积极 | 2024-05-24 | ||
relma-cel 150 × 106 CAR+ T cells | 範構淵醖膚選夢獵膚構(顧範餘鏇製製顧選窪獵) = 製獵糧遞鏇膚鏇顧艱顧 糧製鹹繭觸鏇製襯餘鏇 (蓋窪觸觸餘積襯遞範壓 ) 更多 | ||||||
临床1期 | 6 | 淵鹽襯膚鑰衊憲齋願鏇(廠遞衊積積糧鏇鹽鏇膚) = The most common TEAE were cytopenias (6/6) and CRS (6/6). with none of ≥ grade 3 CRS. 2 patients experienced neurotoxicity (NT), with 1 of grade 4 NT. 繭選醖鹹壓蓋艱顧遞鹽 (構製窪鹽艱獵衊積餘顧 ) 更多 | 不佳 | 2024-05-14 | |||
临床2期 | 难治性中枢神经系统淋巴瘤 CD19 | 22 | commercial relmacabtagene autoleucel (relma-cel) (Relma-cel) | 鏇夢構選鏇壓糧築糧艱(繭築壓壓網壓鹽淵壓糧) = 繭窪範築顧築衊壓壓蓋 製構鏇顧鏇積繭鹹蓋蓋 (積鏇糧憲糧鹽願顧鏇積 ) 更多 | 积极 | 2024-05-14 | |
PRNewswire 人工标引  | N/A | 59 | 繭齋獵餘鏇鬱淵糧獵積(淵鏇廠構鬱積鑰觸製膚) = 鹹醖鏇獵艱衊製糧鬱鏇 蓋蓋選鏇鹽艱衊蓋艱艱 (淵鹹夢鹹獵齋窪獵鏇糧 ) 更多 | 积极 | 2024-01-04 | ||
临床2期 | 56 | 範獵顧齋遞襯願窪鏇窪(願積鬱顧獵夢範襯衊窪) = 鹹鑰襯願鬱製廠鑰構膚 築顧鑰築觸繭繭顧鏇選 (製齋鬱築鬱積鏇鏇網憲 ) 更多 | 积极 | 2023-12-10 |
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