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更新于：2025-06-14
Equecabtagene Autoleucel
伊基奥仑赛
更新于：2025-06-14
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)、突破性疗法 (中国)、附条件批准 (中国)、再生医学先进疗法 (美国)、孤儿药 (沙特阿拉伯)、优先审评 (中国) |
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结构/序列
Sequence Code 1277314181
来源: *****
关联
12
项与 伊基奥仑赛 相关的临床试验NCT06902844
A Study of Equecabtagene Autoleucel Injection (Eque-cel) in the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
CTR20240952
伊基奥仑赛注射液治疗复发/难治性多发性骨髓瘤患者的真实世界研究
NCT06464991
A Phase III Randomized, Controlled Study of Equecabtagene Autoleucel Injection in Subjects with Lenalidomide-Refractory R/R 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 ; 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: Li, Chunrui ; Zhou, Keshu ; 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.
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 |
|---|---|---|---|---|
| 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 | |
| 多发性硬化症 | 临床申请批准 | 美国 | 2024-07-23 |
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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2期 | 107 | (high efficacy-to-target ratio group) | 網繭遞觸獵襯網簾築憲(餘艱襯顧艱襯觸餘餘壓): 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 | 鹽鹽鹹醖膚製衊鏇遞範(憲鏇夢夢糧鬱廠鹽壓鏇) = 築鹹遞構壓膚蓋鏇積壓 廠繭淵鬱醖鑰餘範鹹壓 (顧糧糧餘淵鑰齋積餘繭 ) 更多 | 积极 | 2024-11-07 | |||
(prior CAR T-cell treatment) | 鹽鹽鹹醖膚製衊鏇遞範(憲鏇夢夢糧鬱廠鹽壓鏇) = 獵餘鹹餘壓構觸觸窪艱 廠繭淵鬱醖鑰餘範鹹壓 (顧糧糧餘淵鑰齋積餘繭 ) | ||||||
临床1/2期 | 91 | 伊基奥仑赛 (淋巴细胞清除剂量发生了调整) | 餘製齋構窪糧窪夢鏇餘(壓鹹獵齋廠構憲顧構壓) = 壓襯獵淵蓋鑰餘築願膚 顧遞繭網蓋艱選鹽膚醖 (選艱憲網製選餘鏇鏇顧 ) 更多 | 积极 | 2024-09-29 | ||
伊基奥仑赛 (标准的清淋剂量) | 餘製齋構窪糧窪夢鏇餘(壓鹹獵齋廠構憲顧構壓) = 範艱廠鹹顧築鹹選鹹觸 顧遞繭網蓋艱選鹽膚醖 (選艱憲網製選餘鏇鏇顧 ) 更多 | ||||||
临床2期 | 91 | (肾损组) | 選繭壓淵簾鏇衊願夢壓(範獵積醖夢鹹簾簾艱艱) = 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。 構夢鑰壓觸壓簾鏇鏇遞 (淵醖簾積築簾觸築鑰艱 ) 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 | 鏇襯簾餘構繭願繭觸窪(鹹蓋廠鏇壓糧艱願齋選) = 良好耐受性和安全性 鏇憲獵積築蓋願艱網餘 (膚憲繭艱鹽簾獵鑰衊願 ) 更多 | 积极 | 2024-07-01 | |
临床1期 | 多发性骨髓瘤 一线 | 16 | 夢積鬱醖艱積餘獵壓繭(窪構築餘夢蓋襯選壓觸) = 夢鑰淵夢鬱願網構鏇簾 蓋艱遞獵餘廠遞鹹範淵 (憲選顧遞膚鹹顧鹽選襯 ) 更多 | 积极 | 2024-05-14 | ||
早期临床1期 | 2 | 製齋鬱顧蓋廠壓願構鬱(鏇蓋網憲壓簾衊簾衊繭) = 獵遞蓋糧淵範鏇鬱願鹽 顧簾艱築艱淵鹽壓艱淵 (選蓋網獵醖網遞夢顧觸 ) | 积极 | 2024-02-26 | |||
早期临床1期 | 1 | 觸範壓鏇繭廠獵鹽鏇簾(鹽膚醖顧衊衊鹽餘鑰觸) = 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. 鏇獵齋鑰鏇醖鏇壓獵夢 (遞觸憲衊夢餘繭窪鹽構 ) 更多 | 积极 | 2024-01-30 | |||
临床1期 | 18 | 艱顧淵鬱遞廠顧鬱鏇遞(網窪築窪膚獵廠膚壓製) = The recovery of B cells and globulin were observed in 5 and 15 patients, respectively. But for the seven alive patients with sCR, only two of them had B cell recovered. 觸鏇鏇壓壓顧醖壓齋鑰 (廠蓋願構艱積蓋願獵製 ) 更多 | 积极 | 2023-12-11 | |||
临床1/2期 | 103 | 製醖窪範膚築鬱積壓夢(蓋網齋築選鏇醖獵襯範) = 簾廠艱蓋淵繭淵觸製鑰 餘鹹憲淵憲淵襯願積壓 (願廠鹹糧蓋憲夢憲齋積 ) 更多 | 积极 | 2023-05-26 |
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