预约演示
更新于：2026-08-21
Lisocabtagene maraleucel
利基迈仑赛
更新于：2026-08-21
概要
基本信息
药物类型 自体CAR-T |
别名 anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy、anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy、CD19-directed chimeric antigen receptor T cell therapy + [7] |
靶点 |
作用方式 调节剂 |
作用机制 CD19调节剂(B淋巴细胞抗原CD19调节剂)、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 (2021-02-05), |
最高研发阶段(中国)- |
特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (美国) |
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结构/序列
Sequence Code 133531
来源: *****
Sequence Code 133534
来源: *****
Sequence Code 133555
来源: *****
Sequence Code 133567
来源: *****
Sequence Code 133586
来源: *****
Sequence Code 171111
来源: *****
关联
33
项与 利基迈仑赛 相关的临床试验NCT07711483
Phase 2 Study of Glofitamab and Gemcitabine and Oxaliplatin (Glofit-GemOx) Bridging to Lisocabtagene Maraleucel in Relapsed/Refractory Aggressive B-cell Lymphomas
NCT07194980
Safety and Efficacy of the Addition of Nemtabrutinib to Lisocabtagene Maraleucel in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
NCT07725406
A Phase Ib, Dose-Escalation Study of Augmented Lymphodepletion and CAR T-cell Priming With Low-dose Total Body Irradiation in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphomas and Multiple Myeloma Receiving Treatment With Commercial CD19 or BCMA-directed CAR T-cell Therapies
100 项与 利基迈仑赛 相关的临床结果
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100 项与 利基迈仑赛 相关的转化医学
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100 项与 利基迈仑赛 相关的专利（医药）
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234
项与 利基迈仑赛 相关的文献（医药）2026-08-01Transplantation and Cellular Therapy
Prolonged Cytokine Release Syndrome is Associated with Hypofibrinogenemia after CD19-Directed CAR T-Cell Therapy in Adult Patients with Relapsed/Refractory Lymphoma
Article
作者: Jo, Tomoyasu ; Sakamoto, Takashi ; Bamba, Seiya ; Kitawaki, Toshio ; Arai, Yasuyuki ; Nagao, Miki ; Takaori-Kondo, Akifumi ; Yamashita, Kouhei ; Yoshinaga, Noriyoshi ; Nishikori, Momoko ; Kanda, Junya
CD19-directed chimeric antigen receptor (CAR) T-cell therapy has markedly improved outcomes for patients with relapsed or refractory B-cell malignancies, although coagulopathy characterized by hypofibrinogenemia has increasingly been recognized as a complication after CAR T-cell therapy. Nevertheless, its contemporary real-world incidence, risk factors, and clinical impact remain incompletely defined. This study aimed to determine the real-world incidence, risk factors, and clinical impact of hypofibrinogenemia following CD19-directed CAR T-cell therapy for relapsed or refractory B-cell lymphoma. This retrospective cohort study included all consecutive adult patients (≥16 years) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who received tisagenlecleucel (tisa-cel), lisocabtagene maraleucel (liso-cel), or axicabtagene ciloleucel (axi-cel) at Kyoto University Hospital between December 2019 and December 2024. We also evaluated detailed CRS severity according to modified CRS grading (m-CRS), in which grade 1 was subdivided into grade 1a (duration of CRS-related symptoms ≤5 days) and grade 1b (duration of CRS-related symptoms >5 days), as previously described; grade 1b CRS was defined as "prolonged CRS." A total of 111 patients (74 tisagenlecleucel [tisa-cel] [67%], 24 lisocabtagene maraleucel [liso-cel] [22%], and 13 axicabtagene ciloleucel [axi-cel] [12%]) were included. Hypofibrinogenemia (fibrinogen ≤150 mg/dL) was observed in 28 patients (25%) within 30 days after infusion (median onset, 10.5 days). FFP was administered to 15 patients (14%). Multivariable analysis revealed that grade ≥1b CRS (adjusted hazard ratio [aHR], 4.59; 95% confidence interval [CI], 1.89 to 11.14; P < .01), lower baseline fibrinogen levels (aHR, 1.07 per 10 mg/dL decrease; 95% CI, 1.02 to 1.14; P = .01), and axi-cel use (versus tisa-cel: aHR, 3.29; 95% CI, 1.38 to 7.83; P < .01) were independently associated with hypofibrinogenemia. In our cohort, no fatal bleeding events occurred. Hypofibrinogenemia was not associated with inferior overall survival or progression-free survival. Prolonged CRS (grade 1b) or grade ≥2 CRS, lower baseline fibrinogen, and use of axi-cel were independently associated with hypofibrinogenemia. Risk-adapted fibrinogen monitoring may help identify patients who could benefit from closer surveillance, and timely fibrinogen replacement may optimize supportive care. Further multicenter studies are warranted to validate these findings and clarify the clinical impact of hypofibrinogenemia, including hemorrhagic outcomes.
2026-08-01JOURNAL OF PHARMACEUTICAL SCIENCES
Delay differential equation (DDE) modeling of CAR-T cellular kinetics: Application to BCMA-targeted (Ide-cel, Orva-cel) and CD19-targeted (Lisocel) therapies
Article
作者: Cheng, Yiming ; Li, Yan
Chimeric antigen receptor (CAR) T-cell therapies undergo rapid in vivo expansion followed by contraction and variable long-term persistence after a single infusion, yielding cellular kinetic (CK) profiles that differ fundamentally from conventional small-molecule and biologic pharmacokinetics. Piecewise, phase-based CK models are widely used, but discontinuous switching and constant expansion assumptions can create numerical instability around the transition window and bias the characterization of early expansion and near-peak behavior. Building on our prior saturable expansion framework (Vmax/Km), we advanced CAR-T CK modeling by introducing (i) smooth S-shaped gating to replace discontinuous phase switching and enable continuous time-varying expansion dynamics, and (ii) delay differential equation (DDE) components to evaluate whether longitudinal data support explicit lags in downstream biological processes. Data were pooled from three CAR-T trials (TRANSCEND, KarMMa-3, and EVOLVE) spanning two BCMA-targeted products (ide-cel, orva-cel) and one CD19-targeted product (lisocel). Models were estimated in Monolix using SAEM with importance sampling for final likelihood evaluation. Model selection relied on likelihood-based criteria (AIC, BIC, and Monolix BICc) and diagnostic assessments. Relative to a constant-expansion baseline, saturable expansion improved fit and reduced systematic model misspecification at high transgene levels (e.g., qPCR transgene copies/µg). Among multiple DDE placements evaluated, the data most strongly supported a delay on effector-to-memory conversion; delays in effector-like and/or memory-like decay were not favored. Simulations indicated that the conversion delay primarily modulated the timing and magnitude of the memory-like trajectory, with minimal impact on total-cell trajectories during the expansion phase at the evaluated scale. In a shared covariate framework with product as a categorical effect, BCMA-targeted products exhibited higher baseline levels and expansion capacity than lisocel, with stronger evidence for slower effector-like decay for orva-cel than ide-cel. Overall, smooth-gated saturable expansion with DDE-based delayed conversion provides a parsimonious, biologically motivated framework for CAR-T CK and supports cross-product comparisons under harmonized structural assumptions.
2026-07-14Blood Advances
Drivers of temporal improvement in CAR T-cell therapy for large B-cell lymphoma: a Japanese nationwide registry analysis
Article
作者: Kato, Koji ; Terao, Toshiki ; Kitawaki, Toshio ; Yamamoto, Go ; Goto, Hideki ; Kato, Motohiro ; Yoshihara, Satoshi ; Sakaida, Emiko ; Yagi, Yu ; Atsuta, Yoshiko ; Kim, Haryoon ; Umezawa, Yoshihiro ; Kataoka, Keisuke ; Hanajiri, Ryo ; Shimoyama, Tatsu ; Fujii, Nobuharu ; Jo, Tomoyasu ; Kanemasa, Yusuke ; Sakurai, Masatoshi ; Nakashima, Yasuhiro ; Doki, Noriko ; Matsukawa, Toshihiro ; Yoshida, Akiyo ; Iwaki, Noriko
Abstract:
Real-world CD19 chimeric antigen receptor (CAR) T-cell therapy for large B-cell lymphoma (LBCL) is characterized by expanded eligibility and evolving management practices. However, the prognostic impact of these changes remains inconsistent, and the specific drivers of outcomes remain unclear. This study analyzed 913 patients with relapsed/refractory (R/R) LBCL from a Japanese registry and compared the outcomes between 2 calendar periods (2019-2021 vs 2022-2024). The 2022-2024 cohort was older, had more adverse baseline features, and was less pretreated. Treatment patterns have shifted toward higher utilization of second-line therapy, a growing preference for axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel (liso-cel), and improved disease control before infusion. Accordingly, the 2022-2024 cohort achieved a longer progression-free survival (PFS; 6-month PFS, 63.2% vs 55.2%; P = .005), which persisted after adjusting for baseline characteristics using propensity score matching. Multivariable analysis identified second-line therapy, improved preinfusion disease control, and a shift in product selection from tisagenlecleucel to axi-cel or liso-cel as the primary drivers of this improvement. This benefit was pronounced in high-risk populations, including patients with stable or progressive disease at infusion (6-month PFS, 54.6% vs 43.8%; P = .012) and those who were refractory to first-line therapy (6-month PFS, 51.7% vs 40.3%; P = .013). Despite broader use in higher-risk populations and greater axi-cel exposure, 6-month nonrelapse mortality remained low (2.1% vs 1.5%). Real-world outcomes of CD19 CAR T-cell therapy for R/R LBCL have improved, predominantly driven by second-line therapy, enhanced preinfusion disease control, and increased use of more potent CAR T products.
1,130
项与 利基迈仑赛 相关的新闻（医药）2026-08-20
2026-08-20
100 项与 利基迈仑赛 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 |
|---|---|---|---|
| 复发性套细胞淋巴瘤 | 日本 | 2025-07-25 | |
| 难治性套细胞淋巴瘤 | 日本 | 2025-07-25 | |
| 复发性边缘区淋巴瘤 | 日本 | 2025-07-25 | |
| 难治性边缘区淋巴瘤 | 日本 | 2025-07-25 | |
| 套细胞淋巴瘤 | 美国 | 2024-05-31 | |
| 慢性淋巴细胞白血病 | 美国 | 2024-03-18 | |
| 小淋巴细胞淋巴瘤 | 美国 | 2024-03-18 | |
| 复发性滤泡性淋巴瘤 | 日本 | 2022-12-20 | |
| 难治性滤泡性淋巴瘤 | 日本 | 2022-12-20 | |
| 大B细胞淋巴瘤 | 加拿大 | 2022-05-06 | |
| 复发性弥漫性大B细胞淋巴瘤 | 欧盟 | 2022-04-04 | |
| 复发性弥漫性大B细胞淋巴瘤 | 冰岛 | 2022-04-04 | |
| 复发性弥漫性大B细胞淋巴瘤 | 列支敦士登 | 2022-04-04 | |
| 复发性弥漫性大B细胞淋巴瘤 | 挪威 | 2022-04-04 | |
| 难治性弥漫性大 B 细胞淋巴瘤 | 欧盟 | 2022-04-04 | |
| 难治性弥漫性大 B 细胞淋巴瘤 | 冰岛 | 2022-04-04 | |
| 难治性弥漫性大 B 细胞淋巴瘤 | 列支敦士登 | 2022-04-04 | |
| 难治性弥漫性大 B 细胞淋巴瘤 | 挪威 | 2022-04-04 | |
| 复发性原发性纵隔大B细胞淋巴瘤 | 欧盟 | 2022-04-04 | |
| 复发性原发性纵隔大B细胞淋巴瘤 | 冰岛 | 2022-04-04 |
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 |
|---|---|---|---|---|
| 难治性慢性淋巴细胞白血病 | 申请上市 | 美国 | 2023-11-18 | |
| 复发性慢性淋巴细胞白血病 | 申请上市 | 美国 | 2023-11-18 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 美国 | 2018-10-23 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 日本 | 2018-10-23 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 比利时 | 2018-10-23 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 芬兰 | 2018-10-23 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 法国 | 2018-10-23 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 德国 | 2018-10-23 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 意大利 | 2018-10-23 | |
| 难治性侵袭性非霍奇金淋巴瘤 | 临床3期 | 荷兰 | 2018-10-23 |
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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1/2期 | 大B细胞淋巴瘤 二线 | 420 | 艱糧夢襯選積蓋憲顧願(構艱鏇憲膚鹹醖糧廠膚) = 願鹹衊鹽淵淵範齋鏇獵 鹽壓鹽範糧襯範鬱繭糧 (選願範窪窪醖糧糧選鏇 ) 更多 | 积极 | 2026-05-29 | ||
N/A | 45 | 網蓋夢窪齋糧餘繭齋壓(願夢選積製構糧積鏇醖) = Among pts with any-grade (gr) cytokine release syndrome (80%; gr ≥ 3, 4%) or immune effector cell-associated neurotoxicity syndrome (36%; gr ≥ 3, 13%), no gr 5 events occurred. Clinically significant infections were reported in 40% of pts, and at 30 d after infusion, 18% had persistent gr 4 thrombocytopenia and/or neutropenia. Rates were low of HLH/MAS (7%), second primary malignancies (2%; 1 case of basal cell carcinoma 34 d postinfusion), tumor lysis syndrome (7%), and gr 3/4 organ toxicity (9%). 齋積鹹鑰夢憲繭艱鏇窪 (艱蓋鑰廠淵艱廠齋構築 ) | 积极 | 2026-05-29 | |||
临床2期 | 65 | 簾簾壓構構淵鑰積淵簾(憲顧鹹膚夢醖鹹齋齋觸) = 膚構襯構壓範鹹襯襯鹽 廠積壓壓鬱艱積網鹹鬱 (夢夢鏇獵壓網顧淵糧蓋 ) 更多 | 积极 | 2026-05-29 | |||
N/A | 1,117 | Cilta-cel | 繭艱襯齋構艱衊顧網範(顧餘襯繭廠醖衊積糧廠) = 繭衊衊夢齋獵憲積窪遞 襯觸淵窪襯製願壓鏇襯 (繭網窪願壓獵齋願壓範 ) 更多 | 积极 | 2026-05-29 | ||
Ide-cel | 繭艱襯齋構艱衊顧網範(顧餘襯繭廠醖衊積糧廠) = 衊願觸鹹憲廠夢膚獵蓋 襯觸淵窪襯製願壓鏇襯 (繭網窪願壓獵齋願壓範 ) 更多 | ||||||
N/A | 1,311 | 膚膚鏇壓衊醖簾願壓鹽(鏇廠構壓鹹鹽餘構觸願): HR = 0.86 (95.0% CI, 0.66 ~ 1.11) 更多 | 积极 | 2026-05-29 | |||
N/A | 94 | 選糧餘積夢襯遞鬱繭襯(鏇蓋鑰築網築鏇選顧遞) = 淵醖壓衊窪艱艱齋夢顧 鏇構膚廠構襯蓋遞繭夢 (廠獵糧鏇淵觸築糧製憲 ) 更多 | 积极 | 2026-05-29 | |||
临床2期 | 80 | 鹹鹽築積醖鹹壓顧艱襯(艱衊艱廠鹹獵衊構構觸) = 鹹範憲製醖糧鹹簾顧襯 壓構齋鬱憲憲餘廠願餘 (選積積獵憲繭範鏇獵憲 ) 更多 | 积极 | 2026-05-21 | |||
(PR/SD/PD) | 繭憲鏇觸鬱選糧遞淵顧(構顧醖壓鹽遞積願憲艱) = 夢顧選築窪構顧網淵淵 簾淵窪夢築衊夢蓋獵鹹 (糧繭衊膚簾艱衊醖衊鹹 ) | ||||||
N/A | 94 | (Relapsed or Refractory Mantle Cell Lymphoma) | 築繭艱獵選築顧廠齋淵(壓艱蓋繭醖範觸壓範襯) = Any-grade cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome were reported in 65% (grade ≥ 3, 2%) and 37% (grade ≥ 3, 12%) of patients, respectively, with no grade 5 events. Clinically significant infections were reported in 23% of patients, grade 4 thrombocytopenia and/or neutropenia persistent at 30 days after infusion in 18%, and second primary malignancies in 5%, with skin malignancies being the most common. Grade 3/4 organ toxicity occurred in 1 (1%) patient, and none had tumor lysis syndrome. 餘鏇廠選築夢顧範獵鹹 (鹹廠齋顧鏇窪顧壓選獵 ) | 积极 | 2026-05-21 | ||
N/A | 469 | 餘醖選積襯獵齋醖鬱製(壓範醖鏇積選壓糧簾觸) = 繭鹽膚襯願遞鹽餘繭簾 齋衊願夢淵獵鏇醖繭夢 (壓餘壓糧獵蓋醖壓簾憲 ) 更多 | 积极 | 2026-05-13 | |||
餘醖選積襯獵齋醖鬱製(範積顧夢憲積繭醖鏇願) = 鏇鑰廠網醖構遞願遞襯 構鹹膚衊淵製鹽窪構積 (襯鑰築願積簾淵夢獵壓 ) | |||||||
N/A | 12 | CAR2 | 鹹鏇襯構製壓鑰鬱繭夢(簾製餘鏇積範艱範糧蓋) = 簾鹽構淵衊構遞艱鑰鏇 襯壓齋選壓鬱築鬱積獵 (齋願顧淵網積鏇選夢憲 ) 更多 | 积极 | 2026-05-12 |
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