预约演示
更新于：2026-05-09
Rapcabtagene autoleucel
更新于：2026-05-09
概要
基本信息
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 1292316178
来源: *****
关联
12
项与 Rapcabtagene autoleucel 相关的临床试验NCT07570966
An Open-label, Multi-center, Phase I/II Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
NCT07443137
Rapcabtagene Autoleucel for Eradication of Measurable Residual Disease in Large B-Cell Lymphoma (LBCL)
NCT07048197
An Open-label, Multi-center, Phase 1/2 Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Participants With Difficult-to-treat Rheumatoid Arthritis and Severe, Refractory Sjogren's Disease With Organ Involvement
100 项与 Rapcabtagene autoleucel 相关的临床结果
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100 项与 Rapcabtagene autoleucel 相关的转化医学
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100 项与 Rapcabtagene autoleucel 相关的专利（医药）
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2
项与 Rapcabtagene autoleucel 相关的文献（医药）2023-09-06Cancer discovery
A Novel Autologous CAR-T Therapy, YTB323, with Preserved T-cell Stemness Shows Enhanced CAR T-cell Efficacy in Preclinical and Early Clinical Development
Article
作者: Andrew Price ; Ulrich Jäger ; Xu Zhu ; Anne-Laure Marchal ; Michael J. Dickinson ; Jennifer Yang ; Boris Engels ; Michele Moschetta ; Jaclyn Davis ; Elena J. Orlando ; Nirav N. Shah ; Louise M. Treanor ; Jennifer Mataraza ; Luisa Mariconti ; Didier Blaise ; Darlene Lu ; Pere Barba ; Attilio Bondanza ; Laure Moutouh-de Parseval ; Leyla Shune ; Jennifer L. Brogdon ; Akash Sohoni ; Ian W. Flinn ; Nicolas Boissel ; Javier Briones ; David S. Quinn
Abstract:
CAR T-cell product quality and stemness (Tstem) are major determinants of in vivo expansion, efficacy, and clinical response. Prolonged ex vivo culturing is known to deplete Tstem, affecting clinical outcome. YTB323, a novel autologous CD19-directed CAR T-cell therapy expressing the same validated CAR as tisagenlecleucel, is manufactured using a next-generation platform in <2 days. Here, we report the preclinical development and preliminary clinical data of YTB323 in adults with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL; NCT03960840). In preclinical mouse models, YTB323 exhibited enhanced in vivo expansion and antitumor activity at lower doses than traditionally manufactured CAR T cells. Clinically, at doses 25-fold lower than tisagenlecleucel, YTB323 showed (i) promising overall safety [cytokine release syndrome (any grade, 35%; grade ≥3, 6%), neurotoxicity (any grade, 25%; grade ≥3, 6%)]; (ii) overall response rates of 75% and 80% for DL1 and DL2, respectively; (iii) comparable CAR T-cell expansion; and (iv) preservation of T-cell phenotype. Current data support the continued development of YTB323 for r/r DLBCL.
Significance::
Traditional CAR T-cell manufacturing requires extended ex vivo cell culture, reducing naive and stem cell memory T-cell populations and diminishing antitumor activity. YTB323, which expresses the same validated CAR as tisagenlecleucel, can be manufactured in <2 days while retaining T-cell stemness and enhancing clinical activity at a 25-fold lower dose.See related commentary by Wang, p. 1961.This article is featured in Selected Articles from This Issue, p. 1949
2023-09-06Cancer discovery
Express Delivery of Next-Generation CAR T Cells with Preserved Naive and Stemness Phenotypes for the Treatment of Aggressive Lymphomas
Communications
作者: Wang, Michael
Summary::
In this issue of Cancer Discovery, Dickinson and colleagues present clinical data from a first-in-human study of YTB323, a novel autologous CD19-directed chimeric antigen receptor T-cell therapy generated on the T-Charge platform with preserved naive state and stemness phenotypes. Treatment with YTB323 achieved high overall response rates, durable complete remissions, and good overall safety. Their cell doses are up to 25-fold lower than with tisagenlecleucel.See related article by Dickinson et al., p. 1982 (10).
100 项与 Rapcabtagene autoleucel 相关的药物交易
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研发状态
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 |
|---|---|---|---|---|
| 干燥综合征 | 临床2期 | 法国 | 2025-06-20 | |
| 干燥综合征 | 临床2期 | 德国 | 2025-06-20 | |
| 干燥综合征 | 临床2期 | 新加坡 | 2025-06-20 | |
| 干燥综合征 | 临床2期 | 西班牙 | 2025-06-20 | |
| 重症肌无力 | 临床2期 | 美国 | 2025-04-22 | |
| 重症肌无力 | 临床2期 | 日本 | 2025-04-22 | |
| 重症肌无力 | 临床2期 | 法国 | 2025-04-22 | |
| 重症肌无力 | 临床2期 | 英国 | 2025-04-22 | |
| 肉芽肿伴多血管炎 | 临床2期 | 美国 | 2025-03-13 | |
| 肉芽肿伴多血管炎 | 临床2期 | 日本 | 2025-03-13 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 一线 | 37 | 鹽積繭艱糧鹹構窪餘齋(鑰齋鹽觸繭鬱製構鬱繭) = 餘餘淵鏇鏇憲觸顧糧廠 願網鑰鹹鑰鏇構鬱製獵 (膚糧鹽衊夢糧鑰廠繭醖 ) 更多 | 积极 | 2026-02-04 | ||
临床1期 | 41 | Rapcabtagene autoleucel at DL1 (2.5×10^6 CAR+ cells) | 繭構夢齋願製衊鹹窪積(夢窪簾憲簾鏇齋壓獵醖) = All pts experienced ≥1 adverse event (AE) of any grade (Gr), and 94% had a Gr ≥3 event. 繭築壓窪簾窪餘憲積膚 (鹽糧繭觸衊鏇繭壓膚壓 ) | 积极 | 2025-12-06 | ||
Rapcabtagene autoleucel at DL2 (5×10^6 CAR+ cells) | |||||||
临床2期 | 大B细胞淋巴瘤 一线 | 37 | 憲觸窪獵鹹齋範鏇顧積(餘壓網繭壓網築繭艱膚) = 觸製艱網醖艱遞鹽遞夢 窪醖顧構齋範簾醖獵淵 (選醖淵鏇鹹願構鹹淵鑰 ) 更多 | 积极 | 2025-12-06 | ||
临床2期 | 弥漫性大B细胞淋巴瘤 CD19 | 63 | Rapcabtagene autoleucel 12.5×10^6 cells | 齋獵選繭糧製積願齋蓋(糧鑰網顧鹽鏇夢願糧獵) = 蓋憲襯鹹壓鑰網襯蓋夢 艱醖製齋選鹹衊壓襯齋 (糧淵構觸艱構積鬱壓醖 ) 更多 | 积极 | 2025-05-14 | |
临床2期 | 63 | (12.5x10^6 cells) | 糧憲遞構襯願範觸憲願(膚積夢醖築廠選繭鏇遞) = all gr, 43%; gr ≥3 6% 觸網獵蓋範餘憲糧廠糧 (製鹽鬱遞顧繭獵繭獵選 ) 更多 | 积极 | 2024-12-07 | ||
临床1/2期 | 6 | 範襯選憲醖鑰鬱顧鬱餘(衊顧範簾衊艱淵鏇餘鏇) = Transient lymphodepletion-related cytopenia (grade 3 or 4) was observed in all six patients as expected, including anaemia in three patients and neutropenia in five patients. Hypogammaglobulinaemia, which did not require intravenous immunoglobulin treatment, was a common adverse event. Cytokine release syndrome (CRS) was observed in four of six patients. All CRS events were grade 1 or 2 and resolved following treatment with tocilizumab. No events of immune cell-associated neurotoxicity syndrome were reported. Infectious complications included pneumonia in one patient (grade 2). 壓鏇積獵鹹艱範膚鑰艱 (範觸鬱鏇窪壓鹹積鏇製 ) | 积极 | 2024-06-12 | |||
N/A | - | Rapcabtagene autoleucel at DL2 (12.5x10^6) | 願築構壓鹽鹽齋觸衊製(醖餘網糧蓋憲衊遞壓簾) = 34% experienced cytokine release syndrome (CRS; 1 grade-4 event) 鏇選衊艱築鑰糧膚鏇繭 (獵淵鹹顧簾艱鏇鹹壓鏇 ) 更多 | - | 2023-09-01 | ||
Rapcabtagene autoleucel at DL3 (25x10^6) | |||||||
临床1期 | 45 | 廠鏇構窪衊廠願糧築積(淵簾艱壓顧鬱鹽窪糧壓) = 餘醖衊齋衊淵獵醖憲蓋 繭鏇鏇襯鹹範淵齋獵構 (鏇鑰衊獵鬱壓廠願簾製 ) 更多 | 积极 | 2022-12-11 | |||
临床1期 | 20 | 壓網窪廠觸蓋積襯鑰廠(艱顧醖廠襯選鑰繭選鑰) = 積繭鬱糧襯積蓋網憲艱 衊蓋廠齋餘繭遞築遞鬱 (夢顧壓鬱築窪顧遞襯構 ) 更多 | 积极 | 2022-05-12 | |||
(DL1) | 衊鏇願餘襯獵蓋積簾繭(鑰鑰膚簾鑰蓋餘製鑰鑰) = 醖齋觸鹹醖製蓋範淵鏇 鏇築願廠繭願艱襯廠顧 (窪範淵範獵顧鑰構窪遞 ) 更多 | ||||||
临床1期 | 弥漫性大B细胞淋巴瘤 CD19 Positive | 15 | (DL1) | 築製獵鹽製製壓範鹽鬱(鏇獵齋遞積憲構艱鏇憲) = Four pts (27%) experienced cytokine release syndrome (CRS), including 3 (20%) Gr 1/2 and 1 (7%) Gr 4 (Lee et al, 2014), which met DLT criteria. 醖鏇願網艱膚選構鏇襯 (鑰觸夢窪構淵鬱壓構鏇 ) | 积极 | 2021-11-05 | |
(DL2) |
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