预约演示
更新于：2026-08-24
Obecabatagene autoleucel
欧贝妥基奥仑赛
更新于：2026-08-24
概要
基本信息
药物类型 自体CAR-T |
别名 Anti-CD19 CAR T cell therapy (Autolus Therapeutics)、CD19 CAR T-cells、CD19CAT-41BBZ CAR T-cells + [7] |
靶点 |
作用方式 调节剂、刺激剂 |
作用机制 CD19调节剂(B淋巴细胞抗原CD19调节剂)、免疫刺激剂、T淋巴细胞替代物 |
非在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2024-11-08), |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先药物（PRIME） (欧盟)、再生医学先进疗法 (美国)、附条件批准 (欧盟)、附条件批准 (英国) |
登录后查看时间轴
结构/序列
Sequence Code 1277314386
来源: *****
关联
11
项与 欧贝妥基奥仑赛 相关的临床试验CTIS2025-524169-26-00
An open label multicenter phase II study to investigate the efficacy, safety and tolerability of the Obe-cel in patients with minimal residual disease (MRD) of Philadelphia negative (Ph neg) B-precursor acute lymphoblastic leukaemia (B-ALL) - GMALL-OBECEL
NCT07400029
A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease
NCT07053800
A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
100 项与 欧贝妥基奥仑赛 相关的临床结果
登录后查看更多信息
100 项与 欧贝妥基奥仑赛 相关的转化医学
登录后查看更多信息
100 项与 欧贝妥基奥仑赛 相关的专利（医药）
登录后查看更多信息
46
项与 欧贝妥基奥仑赛 相关的文献（医药）2026-07-01Cancer research communications
CAR T-cell Kinetics, Persistence, and Clinical Outcomes in Adult Patients with Relapsed/Refractory B-cell ALL Treated with Obecabtagene Autoleucel in the FELIX Study
Article
作者: DeAngelo, Daniel J. ; Cluxton, Deborah ; Tholouli, Eleni ; Hodby, Katharine ; Roddie, Claire ; Guerreiro, Manuel ; Bishop, Michael R. ; Shah, Bijal D. ; Barba, Pere ; Yared, Jean A. ; Yallop, Deborah ; Hu, Yanqing ; Brugger, Wolfram ; Logan, Aaron C. ; Dainton-Smith, Heather ; McElwee, Brooke ; Caulfield, Jason ; Raymond, Meera ; Shaughnessy, Paul ; Jabbour, Elias ; Day, William ; Lao-Sirieix, Pierre ; Sandhu, Karamjeet S. ; Park, Jae H.
Abstract:
Assessments of chimeric antigen receptor (CAR) T-cell pharmacokinetics by flow cytometry (FC) and a droplet digital PCR (ddPCR) assay were compared in adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) following treatment with obecabtagene autoleucel (obe-cel) in the phase Ib/II FELIX study (NCT04404660). CAR T-cell persistence and B-cell aplasia (BCA) were then correlated with event-free survival (EFS). Peripheral blood (PB) samples collected from 127 obe-cel–infused patients were tested by FC and ddPCR. The Spearman correlation coefficient was used to measure the correlation between the number of CAR T–positive cells by FC and ddPCR. The impact of CAR T-cell persistence and BCA (B cells <20 cells/μL by FC in PB) on EFS was assessed using Cox proportional hazards regression. ddPCR was observed to statistically correlate with both the surface (0.60, P < 0.0001) and intracellular FC assays (0.74, P < 0.0001). A higher sensitivity for detecting CAR T–cell positive samples was observed with ddPCR, with 58.8% and 41.3% of samples negative by surface and intracellular FC, respectively, being positive by ddPCR. Loss of CAR T-cell persistence (HR, 2.7; 95% CI, 1.4–5.4) and, to a lesser degree, B-cell recovery (HR, 1.7; 95% CI, 0.7–3.8) as time-dependent variables and at month 3 were associated with poorer EFS. ddPCR demonstrated enhanced sensitivity over FC methods for detection of obe-cel persistence. Additionally, ongoing persistence and BCA were associated with longer EFS and may be taken into consideration, together with clinical parameters, in informing decision making.
Significance::
In patients with R/R B-ALL treated with obe-cel, ddPCR assessment of CAR transgene levels produced results consistent with FC while providing superior sensitivity. ddPCR-detected CAR T-cell persistence at month 3 and at any time after infusion correlated with longer EFS versus loss of persistence, therefore potentially informing clinical decision making.
2025-12-01Current Hematologic Malignancy Reports
Transforming the Treatment of Acute Lymphoblastic Leukemia: the Role of Bispecific Antibodies, Antibody-Drug Conjugates, and CAR T-cell Therapy
Review
作者: Chalhoub, Joe ; Haddad, Fadi G ; Khanfour, Sarah ; Sakkal, Shereen ; Najdi, Tala ; Kourie, Hampig Raphael
PURPOSE OF REVIEW:
B-cell acute lymphoblastic leukemia (B-ALL) is a highly aggressive hematologic malignancy, with particularly poor outcomes in relapsed or refractory cases. Relapses remain a major challenge, often resulting in short remission durations and limited survival. This review summarizes emerging therapeutic strategies for B-ALL, focusing on novel immunotherapies and targeted approaches beyond the relapsed/refractory setting.
RECENT FINDINGS:
Transformative therapies such as chimeric antigen receptor (CAR) T-cell therapy, antibody-drug conjugates (ADCs), and bispecific antibodies have shown promising efficacy. Beyond the R/R setting, both blinatumomab and inotuzumab ozogamicin demonstrated high rates of eradication of measurable residual disease (MRD) up to 97% and 80%, respectively. Furthermore, the addition of blinatumomab following chemotherapy in the frontline setting in patients with patients with Philadelphia chromosome (Ph)-negative B-ALL who achieved negative MRD was showing to improve outcomes with a 3-year overall survival rate of 85% compared to 68% with chemotherapy alone. Tisagenlecleucel, brexucabtagene autoleucel, and obecabtagene autoleucel, are chimeric antigen receptor (CAR) T-cell therapies that improved survival compared to chemotherapy alone in patients with relapsed/refractory ALL. In newly diagnosed Ph-positive ALL, chemotherapy-free regimens combining blinatumomab with TKIs resulted in high rates of MRD negativity and improved survival. The combination of blinatumomab and ponatinib led to a 98% MRD negativity rates by next-generation sequencing and a 3-year overall survival of 91% without reliance on allogeneic stem cell transplantation. Novel immunotherapies and targeted agents offer new avenues to improve outcomes in B-ALL. Expanding the use of blinatumomab, inotuzumab ozogamicin, and CAR T-cell therapy across treatment phases, together with strategic sequencing, may help overcome relapsed/refractory disease. These approaches provide renewed hope for achieving durable remissions and extending survival in patients with B-ALL.
2025-10-05CHINESE MEDICAL JOURNAL
Novel CD19 Fast-CAR-T cells vs. CD19 conventional CAR-T cells for the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia
Article
作者: Wang, Lu ; Liu, Li ; Liu, Ligen ; Wang, Sanbin ; Zhang, Cheng ; Zhou, Jian ; Wang, Xiaoqi ; Wang, Jishi ; Ge, Jian ; Tu, Sanfang ; Tan, Xu ; Chen, Shangjun ; Li, Yuhua ; Yao, Han ; Zhang, Xi ; Yi, Hai ; Hu, Yongxian ; Chen, Guo
Abstract:
Background::
Treatment with chimeric antigen receptor-T (CAR-T) cells has shown promising effectiveness in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), although the process of preparing for this therapy usually takes a long time. We have recently created CD19 Fast-CAR-T (F-CAR-T) cells, which can be produced within a single day. The objective of this study was to evaluate and contrast the effectiveness and safety of CD19 F-CAR-T cells with those of CD19 conventional CAR-T cells in the management of R/R B-ALL.
Methods::
A multicenter, retrospective analysis of the clinical data of 44 patients with R/R B-ALL was conducted. Overall, 23 patients were administered with innovative CD19 F-CAR-T cells (F-CAR-T group), whereas 21 patients were given CD19 conventional CAR-T cells (C-CAR-T group). We compared the rates of complete remission (CR), minimal residual disease (MRD)-negative CR, leukemia-free survival (LFS), overall survival (OS), and the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups.
Results::
Compared with the C-CAR-T group, the F-CAR-T group had significantly higher CR and MRD-negative rates (95.7% and 91.3%, respectively; 71.4% and 66.7%, respectively;
P
= 0.036 and
P
= 0.044). No significant differences were observed in the 1-year or 2-year LFS or OS rates between the two groups: the 1-year and 2-year LFS for the F-CAR-T group
vs.
C-CAR-T group were 47.8% and 43.5%
vs
. 38.1% and 23.8% (
P
= 0.384 and
P
= 0.216), while the 1-year and 2-year OS rates were 65.2% and 56.5%
vs
. 52.4% and 47.6% (
P
= 0.395 and
P
= 0.540). Additionally, among CR patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) following CAR-T-cell therapy, there were no significant differences in the 1-year or 2-year LFS or OS rates: 57.1% and 50.0%
vs
. 47.8% and 34.8% (
P
= 0.506 and
P
= 0.356), 64.3% and 57.1%
vs
. 65.2% and 56.5% (
P
= 0.985 and
P
= 0.883), respectively. The incidence of CRS was greater in the F-CAR-T group (91.3%) than in the C-CAR-T group (66.7%) (
P
= 0.044). The incidence of ICANS was also greater in the F-CAR-T group (30.4%) than in the C-CAR-T group (9.5%) (
P
= 0.085), but no treatment-related deaths occurred in the two groups.
Conclusion::
Compared with C-CAR-T-cell therapy, F-CAR-T-cell therapy has a superior remission rate but also leads to a tolerably increased incidence of CRS/ICANS. Further research is needed to explore the function of allo-HSCT as an intermediary therapy after CAR-T-cell therapy.
100 项与 欧贝妥基奥仑赛 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 |
|---|---|---|---|
| 前体B细胞成淋巴细胞白血病淋巴瘤 | 美国 | 2024-11-08 |
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 |
|---|---|---|---|---|
| 复发性 B 细胞急性淋巴细胞白血病 | 申请上市 | 美国 | 2023-11-29 | |
| 难治性 B 细胞急性淋巴细胞白血病 | 申请上市 | 美国 | 2023-11-29 | |
| CD19阳性B细胞急性淋巴细胞白血病 | 临床2期 | 美国 | 2026-02-03 | |
| 狼疮性肾炎 | 临床2期 | 美国 | 2026-01-16 | |
| 狼疮性肾炎 | 临床2期 | 巴西 | 2026-01-16 | |
| 狼疮性肾炎 | 临床2期 | 希腊 | 2026-01-16 | |
| 狼疮性肾炎 | 临床2期 | 英国 | 2026-01-16 | |
| 狼疮性肾炎 | 临床2期 | 越南 | 2026-01-16 | |
| 急性淋巴细胞白血病 | 临床2期 | 美国 | 2020-06-03 | |
| 急性淋巴细胞白血病 | 临床2期 | 西班牙 | 2020-06-03 |
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 | 13 | 襯鑰糧憲鏇憲憲淵簾遞(齋願糧鬱積淵顧鏇淵觸) = One case of liver injury was observed, which fully resolved. This was possibly related to CAR T-cell activity or concomitant medication-related toxicity (anti-infective prophylaxis) and was therefore considered a DLT. 淵餘襯壓艱壓餘醖夢壓 (鏇繭膚願夢壓鬱襯積齋 ) 更多 | 积极 | 2026-06-11 | |||
临床2期 | 35 | 鑰憲糧鬱遞襯鬱鑰鬱鏇(網膚艱窪鏇觸鹹憲餘糧) = 獵廠淵選膚醖願齋構淵 淵壓遞壓廠廠觸淵簾膚 (積憲窪積獵醖願製憲鑰 ) | 积极 | 2026-06-11 | |||
临床1/2期 | 127 | (with EMD) | 夢繭鹽憲鏇蓋鏇壓鏇遞(願網選壓襯築鏇遞積遞) = cytokine release syndrome in pts with and those w/o EMD was 3.7% and 2.0%; the incidence of Grade ≥3 immune effector cell-associated neurotoxicity syndrome was 19% and 4.0%, respectively. 醖鑰蓋艱範蓋繭製選壓 (鹽築遞餘觸網衊淵願網 ) | 积极 | 2026-05-29 | ||
(w/o EMD) | |||||||
临床1期 | 18 | (Progressive Multiple Sclerosis or RRMS with PIRA) | 襯窪襯觸鑰廠製壓鹽廠(構餘構鹽廠膚憲糧顧選) = The primary endpoint of adverse events (AEs) will be collected and monitored. Adverse event-related serious events (AESI) will be closely monitored. 鬱網醖餘觸淵願鹹廠繭 (鹽餘襯範鹽範糧獵衊蓋 ) | 积极 | 2026-02-05 | ||
临床1/2期 | 复发性儿童急性淋巴细胞白血病 CD19 | 20 | 衊淵遞壓餘繭獵襯繭糧(顧膚簾網齋願襯襯製艱) = 鑰蓋廠遞糧齋獵願窪簾 窪糧艱齋築夢選膚夢遞 (蓋範獵選壓憲壓獵製鑰, 75.1 ~ 99.9) 更多 | 积极 | 2026-02-04 | ||
临床1/2期 | 20 | 蓋遞鬱夢繭構繭簾鹹糧(簾網壓鏇鏇膚鏇願繭夢) = 廠襯蓋餘繭鹽製糧襯構 淵簾齋廠範鬱壓窪繭鏇 (鑰築遞壓鏇鏇範獵製獵, 75.1 ~ 99.9) 更多 | 积极 | 2025-12-06 | |||
临床1期 | 10 | 繭憲壓範築選鹽膚網網(遞製積窪蓋顧範積構憲) = a clinically meaningful reduction (to ≤1) 積構鹹艱艱顧製窪築鹹 (襯蓋願鑰醖襯選糧窪簾 ) 更多 | 积极 | 2025-12-06 | |||
临床1期 | 7 | 網憲鏇構壓窪醖鹽窪膚(顧繭鹽鏇廠廠廠選壓顧) = No Gr ≥2 CRS; Transient hypertension was observed in five pts; All pts had Gr ≥3 neutropenia; Infections were transient and manageable; no life-threatening infections were observed. 窪壓餘餘鑰壓鹹願網範 (觸衊醖觸蓋齋鏇衊鹹衊 ) 更多 | 积极 | 2025-10-24 | |||
临床1/2期 | 127 | 鹽選鏇鏇艱壓遞鏇壓艱(廠艱窪膚繭製鏇積蓋衊) = 選積願艱鏇鬱鹹窪淵膚 壓廠築選網艱憲選艱鏇 (廠醖鑰膚願餘鏇鬱夢餘, 60.9 ~ 81.7) | 积极 | 2025-05-30 | |||
(Age <55 years) | 齋餘壓網鑰衊遞夢觸醖(選鑰憲餘觸鹹鹹淵遞鹽) = 選鏇鹽獵觸鑰顧製夢糧 選衊襯鹹觸憲積襯觸鑰 (顧繭衊範蓋窪製鏇鏇醖 ) 更多 | ||||||
临床1/2期 | 127 | Obe-cel <55 years | 襯觸顧鹽窪構糧願構獵(憲鑰憲鹹壓製衊憲構遞) = 襯範襯顧膚壓鑰網網膚 齋鑰觸壓鬱蓋觸衊壓範 (簾選鬱憲淵淵觸夢淵鬱 ) 更多 | 积极 | 2025-05-14 | ||
Obe-cel ≥55 years | 襯觸顧鹽窪構糧願構獵(憲鑰憲鹹壓製衊憲構遞) = 選製鑰廠醖製構願膚獵 齋鑰觸壓鬱蓋觸衊壓範 (簾選鬱憲淵淵觸夢淵鬱 ) 更多 |
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
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
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。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
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