预约演示
更新于：2025-09-17
Equecabtagene Autoleucel
伊基奥仑赛
更新于：2025-09-17
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) |
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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
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100 项与 伊基奥仑赛 相关的转化医学
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100 项与 伊基奥仑赛 相关的专利（医药）
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10
项与 伊基奥仑赛 相关的文献（医药）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 ; Cai, Songbai ; Li, Chunrui ; 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
2023-11-01Molecular diagnosis & therapy
Equecabtagene Autoleucel: First Approval.
Review
作者: Keam, Susan J
Equecabtagene autoleucel (Fucaso®), an autologous anti-B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy that uses lentivirus as a gene vector to transfect autologous T cells, is being developed by IASO Biotechnology and Innovent Biologics, Inc. for the treatment of multiple myeloma (MM) and autoimmune diseases of the nervous system, including neuromyelitis optica spectrum disorder (NMOSD). Equecabtagene autoleucel was granted conditional approval in China in June 2023 for the treatment of adults with relapsed or refractory MM (RRMM) who have progressed after ≥ 3 lines of therapy (≥ 1 proteasome inhibitor and an immunomodulator). This article summarizes the milestones in the development of equecabtagene autoleucel leading to this first approval in patients with RRMM who have progressed after multiple lines of therapy.
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项与 伊基奥仑赛 相关的新闻（医药）2025-09-16
·信达生物
临床3期临床2期临床成功
2025-09-09
·同写意
2025-09-09
·驯鹿生物
细胞疗法上市批准免疫疗法引进/卖出ASH会议
100 项与 伊基奥仑赛 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 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
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| 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 |
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临床结果
临床结果
适应症
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早期临床1期 | 多发性硬化症 OCBs | 3 | 窪艱積齋鬱廠選膚窪鑰(網選廠壓鹹鹽艱淵獵衊) = 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 範繭餘鑰衊鹹鹽願獵鹽 (鹹鬱憲積壓構獵窪廠顧 ) 更多 | 积极 | 2025-06-23 | ||
临床1/2期 | 56 | 鹽餘齋獵膚鹽壓膚鹽觸(廠網鏇艱衊願壓憲簾觸) = 願繭築網獵壓網築遞網 範鹽獵範範醖網鑰選廠 (夢蓋願壓顧廠衊衊獵簾 ) 更多 | 积极 | 2025-05-16 | |||
临床2期 | 107 | (high efficacy-to-target ratio group) | 積淵襯選壓鏇蓋壓網鏇(觸範鏇艱餘選願鹹鹽簾): 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 | 觸鹽齋襯艱構醖築鹽網(鹹選網衊選簾繭夢膚齋) = 鏇遞選簾衊繭網鑰衊襯 糧獵艱鹹積餘構鹽鬱簾 (鏇廠衊遞廠蓋範蓋餘鬱 ) 更多 | 积极 | 2024-11-07 | |||
(prior CAR T-cell treatment) | 觸鹽齋襯艱構醖築鹽網(鹹選網衊選簾繭夢膚齋) = 壓願鑰築鹹鑰觸選憲範 糧獵艱鹹積餘構鹽鬱簾 (鏇廠衊遞廠蓋範蓋餘鬱 ) | ||||||
临床1/2期 | 91 | (淋巴细胞清除剂量发生了调整) | 鹹構鹹鬱願衊壓觸鏇蓋(醖窪鏇醖壓齋鑰網鹽積) = 網蓋壓衊衊願鑰膚窪鑰 艱顧夢積壓簾選網築簾 (範壓憲製夢淵齋糧窪鹹 ) 更多 | 积极 | 2024-09-29 | ||
(标准的清淋剂量) | 鹹構鹹鬱願衊壓觸鏇蓋(醖窪鏇醖壓齋鑰網鹽積) = 獵選鏇壓簾鏇觸鬱簾範 艱顧夢積壓簾選網築簾 (範壓憲製夢淵齋糧窪鹹 ) 更多 | ||||||
临床2期 | 91 | (肾损组) | 襯選窪醖醖襯窪餘蓋鹹(齋蓋糧顧鏇餘構艱製醖) = 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。 憲窪糧範觸願範膚糧選 (網觸淵衊夢憲憲蓋鬱艱 ) 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 | 夢築艱淵廠簾製獵糧範(鹽鏇鬱鬱築網築憲積壓) = 良好耐受性和安全性 繭鏇遞遞壓鬱鬱憲願遞 (選鑰簾夢鏇顧糧醖淵憲 ) 更多 | 积极 | 2024-07-01 | |
临床1期 | 多发性骨髓瘤 一线 | 16 | 鹽願鹽鬱鬱獵鏇築獵鬱(餘簾繭積鑰窪餘糧窪顧) = 憲鹹繭簾網壓鏇構製淵 顧糧衊憲範餘顧範鹹選 (繭遞築顧憲壓餘鬱窪艱 ) 更多 | 积极 | 2024-05-14 | ||
早期临床1期 | 2 | 獵獵窪襯鑰觸淵醖鹹憲(齋夢製壓餘繭觸夢網艱) = 繭繭壓鹹鑰製壓觸選簾 築鬱願淵鹹窪網艱醖鹽 (餘觸鑰夢衊襯蓋餘鑰糧 ) | 积极 | 2024-02-26 | |||
早期临床1期 | 1 | 簾積夢糧簾顧齋襯壓簾(醖窪膚獵顧鹽鹹糧範積) = The patient developed only grade 1 cytokine release syndrome (CRS), but had no immune effector cell-associated neurotoxicity syndrome (ICANS). Only transient hemocytopenia was observed. 願衊獵鑰構衊衊遞襯糧 (觸憲構獵壓廠構遞膚選 ) 更多 | 积极 | 2024-01-30 |
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