预约演示
更新于：2025-02-18
Inaticabtagene Autoleucel
纳基奥仑赛
更新于：2025-02-18
概要
基本信息
药物类型 自体CAR-T |
别名 Anti-CD19 CAR-T cell therapy (Heyuan Biotech)、Anti-CD19 Chimeric Antigen Receptor T-Cell Injection (Juventas Cell)、抗CD19嵌合抗原受体T细胞 (CAR-T)疗法 (天津合源生物) + [8] |
靶点 |
作用机制 CD19抑制剂(B淋巴细胞抗原CD19抑制剂) |
在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2023-11-07), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国) |
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结构/序列
Sequence Code 1277313892
来源: *****
关联
28
项与 纳基奥仑赛 相关的临床试验NCT06826430
A Multi-center, Open-label, Single-arm Phase I Clinical Study to Evaluate the Safety and Tolerability of Inaticabtagene Autoleucel Injection in Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
NCT06777264
Clinical Study on Inaticabtagene Autoleucel (Inati-cel; CNCT19) Injection for Adolescents and Adults With B-Cell Acute Lymphoblastic Leukemia in First Complete Remission (CR1)
NCT06676982
Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma
100 项与 纳基奥仑赛 相关的临床结果
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100 项与 纳基奥仑赛 相关的转化医学
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100 项与 纳基奥仑赛 相关的专利（医药）
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3
项与 纳基奥仑赛 相关的文献（医药）2025-02-25Blood Advances
Inaticabtagene autoleucel in adult relapsed or refractory B-cell acute lymphoblastic leukemia
Article
作者: Xu, Kailin ; Wang, Ying ; Yan, Dongmei ; Song, Yongping ; Liang, Aibin ; Wei, Xudong ; Zhou, Hongsheng ; Jin, Wei ; Liu, Qifa ; Lv, Lulu ; Wang, Jianxiang ; Ren, Jienan ; Mei, Heng ; Zhang, Cheng ; Zhou, Yan ; Feng, Yi ; Gu, Runxia ; Deng, Yiping ; Liu, Shuangyou ; Jin, Jie ; Niu, Ting
Abstract:
Before November 2023, CD19 chimeric antigen receptor (CAR) T-cell therapies had not been approved in China for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), leaving a significant unmet need. In response, inaticabtagene autoleucel (Inati-cel), a novel CD19 CAR T-cell therapy with a distinct single-chain variable fragment (HI19α), was developed and showed promising efficacy in preliminary clinical research. We conducted a phase 2, single-arm, multicenter study of Inati-cel in adult CD19+ R/R B-ALL in China. The primary end point was the overall remission rate (ORR) at the end of month 3. Forty-eight patients who underwent Inati-cel infusion were evaluated for both efficacy and safety. Among them, 34 patients achieved and maintained remission beyond 3 months, with a 3-month ORR of 70.8% (95% confidence interval [CI], 55.9-83.1). The best ORR was 85.4%, with all responders reaching minimal residual disease negativity. With a median follow-up of 23.7 months, the median duration of remission was 20.7 months (95% CI, 6.4 to not reached), and the median overall survival was not reached (95% CI, 13.0 months to not reached). Additionally, grade ≥3 cytokine release syndrome and neurologic events occurred in 12.5% and 6.2% of patients, respectively. The 2-year follow-up data suggest that Inati-cel demonstrates encouraging and durable responses with manageable safety profiles in R/R B-ALL. Based on the data from this pivotal trial, Inati-cel was approved as the first CAR T-cell therapy for adult R/R B-ALL in China and underscores its potential therapeutic benefits for this patient population. This trial was registered at www.ClinicalTrials.gov as #NCT04684147.
2024-04-01Journal for immunotherapy of cancer
Combinational therapy of CAR T-cell and HDT/ASCT demonstrates impressive clinical efficacy and improved CAR T-cell behavior in relapsed/refractory large B-cell lymphoma
Article
作者: Zou, Dehui ; Ma, Yueshen ; Xu, Yan ; Xiong, Wenjie ; Liu, Wei ; Wang, Jianxiang ; Chen, Lianting ; Yi, Shuhua ; Zheng, Wenting ; Deng, Shuhui ; Peng, Guangxin ; Wang, Yi ; Lv, Lulu ; Huang, Wenyang ; Liu, Huimin ; Wang, Kefei ; Sui, Weiwei ; Wei, Jun ; Zou, Hesong ; Wang, Huijun ; Shi, Yin ; Lv, Rui ; Qiu, Lugui
Background:
Approximately two-thirds of patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) do not respond to or relapse after anti-CD19 chimeric antigen receptor T (CAR T)-cell therapy, leading to poor outcomes. Previous studies have suggested that intensified lymphodepletion and hematological stem cell infusion can promote adoptively transferred T-cell expansion, enhancing antitumor effects. Therefore, we conducted a phase I/II clinical trial in which CNCT19 (an anti-CD19 CAR T-cell) was administered after myeloablative high-dose chemotherapy and autologous stem cell transplantation (HDT/ASCT) in patients with R/R LBCL.
Methods:
Transplant-eligible patients with LBCL who were refractory to first-line immunochemotherapy or experiencing R/R status after salvage chemotherapy were enrolled. The study aimed to evaluate the safety and efficacy of this combinational therapy. Additionally, frozen peripheral blood mononuclear cell samples from this trial and CNCT19 monotherapy studies for R/R LBCL were used to evaluate the impact of the combination therapy on the in vivo behavior of CNCT19 cells.
Results:
A total of 25 patients with R/R LBCL were enrolled in this study. The overall response and complete response rates were 92.0% and 72.0%, respectively. The 2-year progression-free survival rate was 62.3%, and the overall survival was 68.5% after a median follow-up of 27.0 months. No unexpected toxicities were observed. All cases of cytokine release syndrome were of low grade. Two cases (8%) experienced grade 3 or higher CAR T-cell-related encephalopathy syndrome. The comparison of CNCT19 in vivo behavior showed that patients in the combinational therapy group exhibited enhanced in vivo expansion of CNCT19 cells and reduced long-term exhaustion formation, as opposed to those receiving CNCT19 monotherapy.
Conclusions:
The combinational therapy of HDT/ASCT and CNCT19 demonstrates impressive efficacy, improved CNCT19 behavior, and a favorable safety profile.
Trial registration numbers:
ChiCTR1900025419 andNCT04690192.
2020-12-01Journal of hematology & oncology1区 · 医学
Efficacy and safety of CD19 CAR T constructed with a new anti-CD19 chimeric antigen receptor in relapsed or refractory acute lymphoblastic leukemia
1区 · 医学
ArticleOA
作者: Chen, Xiaojuan ; Zhou, Chunlin ; Wang, Jianxiang ; Xu, Yingxi ; Zou, Dehui ; Lv, Lulu ; Lv, Rui ; Zhong, Mengjun ; Liu, Fang ; Lu, Yang ; Zhu, Xiaofan ; Liu, Wei ; Liu, Kaiqi ; Liu, Bingcheng ; Wang, Huijun ; Wang, Ying ; Wang, Min ; Gong, Xiaoyuan ; Qiu, Lugui ; Chen, Xia ; Wei, Hui ; Gu, Runxia ; Guo, Ye ; Mi, Yingchang
Abstract:
Background:
Recent evidence suggests that resistance to CD19 chimeric antigen receptor (CAR)-modified T cell therapy may be due to the presence of CD19 isoforms that lose binding to the single-chain variable fragment (scFv) in current use. As such, further investigation of CARs recognize different epitopes of CD19 antigen may be necessary.
Methods:
We generated a new CD19 CAR T (HI19α-4-1BB-ζ CAR T, or CNCT19) that includes an scFv that interacts with an epitope of the human CD19 antigen that can be distinguished from that recognized by the current FMC63 clone. A pilot study was undertaken to assess the safety and feasibility of CNCT19-based therapy in both pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (R/R B-ALL).
Results:
Data from our study suggested that 90% of the 20 patients treated with infusions of CNCT19 cells reached complete remission or complete remission with incomplete count recovery (CR/CRi) within 28 days. The CR/CRi rate was 82% when we took into account the fully enrolled 22 patients in an intention-to-treat analysis. Of note, extramedullary leukemia disease of two relapsed patients disappeared completely after CNCT19 cell infusion. After a median follow-up of 10.09 months (range, 0.49–24.02 months), the median overall survival and relapse-free survival for the 20 patients treated with CNCT19 cells was 12.91 months (95% confidence interval [CI], 7.74–18.08 months) and 6.93 months (95% CI, 3.13–10.73 months), respectively. Differences with respect to immune profiles associated with a long-term response following CAR T cell therapy were also addressed. Our results revealed that a relatively low percentage of CD8+ naïve T cells was an independent factor associated with a shorter period of relapse-free survival (p = 0.012, 95% CI, 0.017–0.601).
Conclusions:
The results presented in this study indicate that CNCT19 cells have potent anti-leukemic activities in patients with R/R B-ALL. Furthermore, our findings suggest that the percentage of CD8+ naïve T cells may be a useful biomarker to predict the long-term prognosis for patients undergoing CAR T cell therapy.
Trial registration:
ClinicalTrials.gov: NCT02975687; registered 29 November, 2016. https://clinicaltrials.gov/ct2/keydates/NCT02975687
100 项与 纳基奥仑赛 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 难治性 B 细胞急性淋巴细胞白血病 | 中国 |  合源生物科技（天津）有限公司初创企业 | 2023-11-07 |
| 复发性 B 细胞急性淋巴细胞白血病 | 中国 | 合源生物科技（天津）有限公司初创企业 | 2023-11-07 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 大B细胞淋巴瘤 | 申请上市 | 中国 | 合源生物科技（天津）有限公司初创企业 | 2024-09-26 |
| CD19阳性B细胞急性淋巴细胞白血病 | 临床2期 | 中国 | 合源生物科技（天津）有限公司初创企业 | 2024-08-01 |
| 前体B细胞急性淋巴细胞白血病 | 临床2期 | 中国 | 合源生物科技（天津）有限公司初创企业 | 2023-02-07 |
| CD19阳性急性淋巴细胞白血病 | 临床2期 | 中国 | 合源生物科技（天津）有限公司初创企业 | 2020-12-24 |
| 难治性非霍奇金淋巴瘤 | 临床2期 | 中国 | 合源生物科技（天津）有限公司初创企业 | 2020-10-26 |
| 复发性非霍奇金淋巴瘤 | 临床2期 | 中国 | 合源生物科技（天津）有限公司初创企业 | 2020-10-26 |
| 非霍奇金淋巴瘤 | 临床2期 | - | - | |
| 免疫性血小板减少症 | 临床1期 | - | 合源生物科技（天津）有限公司初创企业 | 2025-03-01 |
| 晚期肝细胞癌 | 临床1期 | 中国 | 合源生物科技（天津）有限公司初创企业 | 2025-01-07 |
| 自身免疫性溶血性贫血 | 临床1期 | 中国 | 合源生物科技（天津）有限公司初创企业 | 2024-02-04 |
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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 | 48 | 廠願願廠製簾淵遞廠製(淵製壓鬱繭顧積夢醖網) = 憲衊鏇簾鹽餘製獵廠鑰 窪廠遞憲膚糧夢鬱衊製 (顧鏇餘遞齋網醖願蓋鑰 ) 更多 | 积极 | 2024-12-09 | |||
临床1期 | B细胞淋巴瘤 末线 | 三线 | 9 | (CNCT19 1×10^8 CAR+ T cells) | 願鹽鏇蓋鏇齋顧繭餘艱(鏇齋築齋窪構築製艱獵) = 淵顧獵鹽齋鏇鑰構憲壓 壓獵鹹積鏇窪膚製艱鑰 (夢壓壓廠艱鏇膚獵鬱構 ) 更多 | 积极 | 2024-05-14 | |
临床1/2期 | 25 | CNCT19 + HDT/ASCT | 膚衊鑰鹽積選鹹憲齋鏇(繭鬱範廠餘壓憲夢鏇築) = 遞網構鏇構範鏇膚簾憲 獵簾鹽窪築鹹觸醖蓋窪 (壓鹽顧襯簾鹽膚憲醖網 ) 更多 | 积极 | 2024-04-16 | ||
临床2期 | 36 | cyclophosphamide+fludarabine+CNCT19 (OCR within 3 Months) | 鑰窪廠艱顧膚觸廠遞艱(醖蓋淵願憲鑰願夢鹹廠) = 鏇鏇選範壓鏇選願獵衊 膚憲獵觸積鹽餘壓齋鏇 (願鹽窪醖夢範範憲願選, 70.5 ~ 95.3) 更多 | 积极 | 2022-11-15 | ||
cyclophosphamide+fludarabine+CNCT19 (OCR at the end of Month 3) | 鑰窪廠艱顧膚觸廠遞艱(醖蓋淵願憲鑰願夢鹹廠) = 獵鬱廠艱鏇壓構鏇選蓋 膚憲獵觸積鹽餘壓齋鏇 (願鹽窪醖夢範範憲願選, 46.8 ~ 81.4) 更多 |
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