预约演示
更新于：2025-10-31
Equecabtagene Autoleucel
伊基奥仑赛
更新于：2025-10-31
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、孤儿药 (韩国)、再生医学先进疗法 (美国)、孤儿药 (沙特阿拉伯)、附条件批准 (中国) |
登录后查看时间轴
结构/序列
Sequence Code 1277314181
来源: *****
关联
13
项与 伊基奥仑赛 相关的临床试验NCT07055724
Exploratory Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T-cell Injection (Equecabtagene Autoleucel, Eque-cel) for the Treatment of Newly Diagnosed Mayo Stage IIIb AL Amyloidosis Patients
NCT06902844
A Study of Equecabtagene Autoleucel Injection (Eque-cel) in the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
NCT06369935
A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma.
100 项与 伊基奥仑赛 相关的临床结果
登录后查看更多信息
100 项与 伊基奥仑赛 相关的转化医学
登录后查看更多信息
100 项与 伊基奥仑赛 相关的专利（医药）
登录后查看更多信息
12
项与 伊基奥仑赛 相关的文献（医药）2025-10-01CELL
Anti-BCMA CAR-T therapy in patients with progressive multiple sclerosis
Article
作者: Pang, Xiao-Wei ; Wang, Di ; Ye, Huan ; Tian, Dai-Shi ; Chu, Yun-Hui ; Dong, Ming-Hao ; He, Jia-Yi ; Meyer Zu Hörste, Gerd ; Zhu, Li ; Bu, Bi-Tao ; Xiao, Jun ; Li, Chun-Rui ; Cai, Song-Bai ; Zhou, Luo-Qi ; Qin, Chuan ; Wang, Wei ; Shang, Ke
Progressive multiple sclerosis (PMS), which is characterized by relentless disease progression, lacks effective treatment. While recent studies have highlighted the importance of B cells in driving compartmentalized central nervous system (CNS) inflammation in PMS pathogenesis, current B cell depletion therapies, such as CD20 monoclonal antibodies, face challenges in targeting plasma cells within the CNS. Here, we treated five patients with PMS (one primary PMS and four secondary PMS) with anti-B cell maturation antigen (BCMA) chimeric antigen receptor T (CAR-T) cell therapy in an ongoing phase 1 clinical trial (ClinicalTrials.gov: NCT04561557). Only grade 1 cytokine release syndrome was observed, and all grade ≥3 cytopenias occurred within 40 days post-infusion in all five patients. Meanwhile, we detected plasma cell depletion in CNS compartments, prolonged expansion and relieved exhaustion of CAR-T cells in the cerebrospinal fluid, and attenuation of microglial activation. These findings provided insights into the potential application of anti-BCMA CAR-T therapy for advancing clinical management of PMS.
2025-06-01MOLECULAR THERAPY
Long-term safety and efficacy of the fully human CAR-T therapy CT103A in relapsed/refractory multiple myeloma
Article
作者: Jiang, Lijun ; Long, Xiaolu ; Ye, Huan ; Wang, Wen ; Yu, Qiuxia ; Du, Aihua ; Hu, Guang ; Li, Zhe ; Wen, Xinyu ; Wang, Di ; Gui, Hongyu ; Zhang, Peiling ; Bao, Yuhan ; An, Ning ; Wang, Jue ; Mu, Wei ; Li, Chunrui ; Cai, Songbai ; Li, Chunhui ; Shu, Chang
CT103A is a fully human chimeric antigen receptor T cell (CAR-T) product for targeting B cell maturation antigen. This study presents the updated safety and efficacy profiles of CT103A in patients with relapsed/refractory multiple myeloma (RRMM) after long-term follow-up. As of July 31, 2023, the median follow-up time after CAR-T cell infusion was 45.0 months (range, 0.7-58.3 months). During long-term follow-up, the incidence of adverse events gradually decreased over time. One patient had a maximum duration of response of nearly 5 years. All 18 patients (100%) achieved partial remission or better; 77.8% (14 of 18) of patients eventually exhibited complete response or stringent complete response (sCR), with response increasing over time. At the time of data cutoff, nine patients were still alive and seven patients had an sCR status with negative minimal residual disease. The median progression-free survival was 22.6 months, and the median overall survival was 50.2 months for all 18 patients. The median CAR transgene persistence was 14.0 months (range, 0.7-57.3 months). Long-term follow-up demonstrated that CT103A confers durable clinical benefit for RRMM patients based on the sustained presence of fully human CAR-T cells.
2024-12-01JAMA Oncology
Equecabtagene Autoleucel in Patients With Relapsed or Refractory Multiple Myeloma
Article
作者: Zhou, Keshu ; Li, Chunrui ; Chen, Lijuan ; Mi, Jian-Qing ; Chen, Bing ; Zou, Dehui ; Liu, Jing ; Ren, Hanyun ; Li, Zhenyu ; Song, Yongping ; Ding, Kaiyang ; Huang, He ; Hu, Yongxian ; Hu, Kai ; Liu, Peng ; Li, Jianyong ; Zhang, Xi ; Wang, Wen ; Cai, Songbai ; Qiu, Lugui ; Wang, Di
Importance:
Equecabtagene autoleucel (eque-cel), a fully human-derived B-cell maturation antigen-targeting chimeric antigen receptor (CAR) T-cell therapy, has exhibited potential for the treatment of relapsed or refractory multiple myeloma (RRMM), and further investigation in a larger cohort is necessary.
Objective:
To evaluate whether eque-cel can benefit patients with RRMM and determine the overall response rate postinfusion.
Design, Setting, and Participants:
The FUMANBA-1 trial was a single-arm, open-label, phase 1b/2 trial that evaluated eque-cel in adult patients with RRMM. Enrollment began in April 2020, and patients who received eque-cel will be monitored for a minimum of 15 years following the infusion. As of September 2022, patients with heavily pretreated RRMM who received at least 3 prior courses of therapy from 14 centers were enrolled. Data were analyzed from April 2020 to September 2022.
Interventions:
Patients received a single infusion of eque-cel at 1.0 × 106 CAR-positive T cells/kg after the lymphodepletion.
Main Outcomes and Measures:
Efficacy was the primary objective, and safety, pharmacokinetics, and pharmacodynamics were secondary objectives.
Results:
Of 103 patients who received an eque-cel infusion, 55 (53.4%) were male, and the median (range) age was 58 (39-70) years. A total of 101 patients were evaluable for efficacy. At a median (range) follow-up of 13.8 (0.4-27.2) months, the overall response rate was 96.0% (97 of 101), with 74.3% (75 of 103) achieving a complete response or better. Among the 12 patients who had prior CAR T-cell treatment, 75% (9 of 12) achieved a response. The median progression-free survival was not reached, with a 12-month progression-free survival rate of 78.8% (95% CI, 68.6-86.0). A total of 96 patients (95.0%) achieved minimal residual disease negativity at a sensitivity threshold of 10−5. Adverse events were favorable: 96 of 103 patients (93.2%) experienced cytokine release syndrome (grade 1 to 2 in 95 patients [92.3%]) and 2 (1.9%) experienced immune effector cell–associated neurotoxicity syndrome (grade 1 to 2). All cases of immune effector cell–associated neurotoxicity syndrome and 94 of 96 cases of cytokine release syndrome resolved with treatment. Additionally, only 20 patients (19.4%) developed antidrug antibodies. Cellular kinetic analysis confirmed CAR-positive T cells in all patients, with the longest duration at 735 days.
Conclusions and Relevance:
In this trial, eque-cel led to early, deep, and durable responses in patients with heavily pretreated RRMM with a manageable safety profile. Patients with prior CAR T-cell therapy also benefitted from eque-cel.
Trial Registration:
Chinese Clinical Trial Registry Identifier: ChiCTR2000033946
736
项与 伊基奥仑赛 相关的新闻（医药）2025-10-31
·赛柏蓝
一致性评价引进/卖出
2025-10-31
引进/卖出抗体药物偶联物申请上市临床结果
2025-10-31
抗体药物偶联物细胞疗法免疫疗法多肽偶联药物
100 项与 伊基奥仑赛 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 难治性多发性骨髓瘤 | 中国 | 2023-06-30 | |
| 难治性多发性骨髓瘤 | 中国 | 2023-06-30 | |
| 复发性多发性骨髓瘤 | 中国 | 2023-06-30 | |
| 复发性多发性骨髓瘤 | 中国 | 2023-06-30 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 免疫球蛋白轻链淀粉样变性 | 临床2期 | - | 2025-07-01 | |
| 多发性骨髓瘤 | 临床1期 | 美国 | 2021-11-20 | |
| 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 | 临床1期 | 中国 | 2020-09-22 | |
| 桥本脑炎 | 临床1期 | 中国 | 2020-09-22 | |
| 特发性炎症性肌病 | 临床1期 | 中国 | 2020-09-22 | |
| 原发性进行性多发性硬化 | 临床1期 | 中国 | 2020-09-22 | |
| 重症肌无力 | 临床1期 | 中国 | 2020-09-22 | |
| 髓鞘少突胶质细胞糖蛋白抗体相关疾病 | 临床1期 | 中国 | 2020-09-22 | |
| POEMS综合征 | 临床1期 | 中国 | 2020-09-22 | |
| 慢性炎症性脱髓鞘性多发性神经病 | 临床1期 | 中国 | 2020-09-22 |
登录后查看更多信息
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 | 5 | 鑰積醖膚觸鬱觸鏇鏇膚(蓋鬱遞遞願餘蓋獵齋顧) = All five patients demonstrated significant improvements. 簾獵願積壓齋衊獵醖顧 (餘餘願製壓鏇膚壓夢壓 ) 更多 | 积极 | 2025-10-15 | |||
临床1/2期 | 多发性骨髓瘤 末线 | 109 | 膚憲製顧壓餘繭廠餘築(醖餘觸壓鏇積艱鏇廠簾) = 繭鹽鬱觸鹽夢鏇鹽鹽艱 範齋範鏇艱襯簾繭願獵 (顧鬱鹽壓餘夢簾襯鹽獵 ) 更多 | 积极 | 2025-09-19 | ||
(CAR-T初治患者) | 膚憲製顧壓餘繭廠餘築(醖餘觸壓鏇積艱鏇廠簾) = 觸壓糧遞窪積艱製簾積 範齋範鏇艱襯簾繭願獵 (顧鬱鹽壓餘夢簾襯鹽獵 ) 更多 | ||||||
早期临床1期 | 多发性硬化症 OCBs | 3 | 衊膚簾選窪觸遞鏇膚遞(選淵顧糧鏇網願鹽鏇憲) = 末次随访时所有患者EDSS评分较基线均显著改善；上肢灵活性（九孔柱测试）和下肢行走能力（25英尺步行测试）明显提升 蓋醖鬱選構獵糧齋鹹廠 (襯鹹鹽鹹鹽糧壓廠觸獵 ) 更多 | 积极 | 2025-06-23 | ||
临床1/2期 | 56 | 願襯鑰選餘鹽艱衊積簾(憲襯鏇繭壓鏇製襯願夢) = 獵鑰膚製窪網鑰繭憲願 壓願廠願醖蓋膚艱憲襯 (獵餘鬱獵廠鹽窪醖衊網 ) 更多 | 积极 | 2025-05-16 | |||
临床2期 | 107 | (high efficacy-to-target ratio group) | 繭選淵遞繭襯範製夢鑰(艱鹹鑰壓廠鬱醖襯艱襯): HR = 2.3 (95% CI, 1.27 ~ 4.14), P-Value = 0.0045 更多 | 积极 | 2024-12-09 | ||
(a low ratio group) | |||||||
临床1/2期 | 103 | 鑰鹽壓齋顧夢鑰鹹襯鬱(糧醖積夢齋壓膚築願衊) = 鹹窪壓選鏇願觸衊積膚 繭夢廠願鏇夢膚鬱廠顧 (襯襯糧積廠網構選願製 ) 更多 | 积极 | 2024-11-07 | |||
(prior CAR T-cell treatment) | 鑰鹽壓齋顧夢鑰鹹襯鬱(糧醖積夢齋壓膚築願衊) = 淵鏇糧獵鹹艱積壓鹽窪 繭夢廠願鏇夢膚鬱廠顧 (襯襯糧積廠網構選願製 ) | ||||||
临床1/2期 | 91 | (淋巴细胞清除剂量发生了调整) | 壓積糧鹹淵淵鏇鏇鹽範(鹽壓憲廠範顧襯遞範艱) = 繭鬱顧糧繭觸繭網願餘 繭遞餘鑰觸憲夢壓衊憲 (簾醖獵範製膚鬱餘壓獵 ) 更多 | 积极 | 2024-09-29 | ||
(标准的清淋剂量) | 壓積糧鹹淵淵鏇鏇鹽範(鹽壓憲廠範顧襯遞範艱) = 簾鬱夢鏇繭鏇鬱選廠顧 繭遞餘鑰觸憲夢壓衊憲 (簾醖獵範製膚鬱餘壓獵 ) 更多 | ||||||
临床2期 | 91 | (肾损组) | 積觸顧網獵網淵鬱壓餘(構襯醖觸願獵顧廠艱齋) = 在疗效方面，肾损组的大多数基线特征与非肾损组相当。肾损组也能实现与非肾损组一样快速和深入的缓解。肾损组的长期疗效与非肾损组相当。 齋艱構繭繭膚簾淵顧窪 (廠構積鹽遞鏇鑰憲鏇衊 ) 更多 | 积极 | 2024-09-27 | ||
(非肾损组) | |||||||
早期临床1期 | 神经系统自身免疫性疾病 AQP4抗体阳性 | 12 | 伊基奥仑赛注射液 | 選壓膚鬱蓋願醖膚襯繭(膚遞遞選窪遞獵廠窪製) = 良好耐受性和安全性 範廠鏇壓襯襯鏇網繭獵 (醖鹽窪鬱選願淵窪鏇繭 ) 更多 | 积极 | 2024-07-01 | |
临床1期 | 多发性骨髓瘤 一线 | 16 | 夢壓範糧簾齋遞齋範蓋(鹹願蓋鹹鏇淵繭憲繭壓) = 鬱淵壓鏇簾廠獵淵範構 齋餘構遞襯積鏇鹽繭襯 (壓蓋憲窪鹹簾鹽夢廠網 ) 更多 | 积极 | 2024-05-14 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用