更新于：2024-12-26
GC007g
更新于：2024-12-26
概要
基本信息
药物类型 通用型CAR-T |
别名 Anti-CD19 allo-CAR-T Cells、Anti-CD19 UCAR-T cells、Donor-derived anti-CD19 chimeric antigen receptor cell therapy + [3] |
靶点 |
作用机制 CD19调节剂(B淋巴细胞抗原CD19调节剂) |
在研适应症 |
非在研适应症 |
原研机构 |
在研机构 |
最高研发阶段早期临床1期 |
首次获批日期- |
最高研发阶段(中国)早期临床1期 |
特殊审评- |
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序列信息
Sequence Code 1117836312
关联
5
项与 GC007g 相关的临床试验GC007g注射液治疗异基因移植后复发难治性CD19+急性B淋巴细胞白血病的I/II期临床研究
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
GC007g 注射液治疗异基因移植后复发难治性 CD19+急性B 淋巴细胞 白血病的I 期临床研究
100 项与 GC007g 相关的临床结果
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100 项与 GC007g 相关的转化医学
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100 项与 GC007g 相关的专利（医药）
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9
项与 GC007g 相关的文献（医药）2024-04-01EClinicalMedicine
CD19-CAR-DNT cells (RJMty19) in patients with relapsed or refractory large B-cell lymphoma: a phase 1, first-in-human study
Article
作者: Chen, Panpan ; Qiu, Xi ; Liu, Hui ; Wang, Dan ; Li, Xian ; Xiao, Xibin ; Cheng, Yu ; Qian, Wenbin ; Yang, Liming ; Song, Guangrong
Background:
Current approved chimeric antigen receptor (CAR) T-cell products are autologous cell therapies that are costly and poorly accessible to patients. We aimed to evaluate the safety and antitumor activity of a novel off-the-shelf anti-CD19 CAR-engineered allogeneic double-negative T cells (RJMty19) in patients with relapsed/refractory large B-cell lymphoma. We report the results from a first-in-human, open-label, single-dose, phase 1 study of allogeneic CD19-specific CAR double-negative T (CAR-DNT) cells.
Methods:
Eligibility criteria included the presence of measurable lesions, at least 2 lines of prior immunochemotherapy, and an ECOG score of 0-1. We evaluated four dose levels (DL) of RJMty19 in a 3 + 3 dose-escalation scheme: 1 × 106, 3 × 106, 9 × 106 and 2 × 107 CAR-DNT cells per kilogram of body weight. All patients received lymphodepleting chemotherapy with fludarabine and cyclophosphamide. The primary endpoints were dose-limiting toxicities (DLTs), incidence of adverse events (AEs), and clinically significant laboratory abnormalities. Secondary endpoints included evaluation of standard cellular pharmacokinetic parameters, immunogenicity, objective response rates (ORR), and disease control rate (DCR) per Lugano 2014 criteria.
Findings:
A total of 12 patients were enrolled between 22 July 2022 and 27 July 2023. Among these patients, 66% were classified as stage IV, 75% had an IPI score of 3 or higher, representing an intermediate risk or worse. The maximum tolerated dose was not reached because no DLT was observed. Four patient experienced grade 1 or 2 cytokine release syndrome and dizziness. The most common AEs were hematologic toxicities, including neutropenia (N = 12, 100%), leukopenia (N = 12, 100%), lymphopenia (N = 10, 83%), thrombocytopenia (N = 6, 50%), febrile neutropenia (N = 3, 25%), and anemia (N = 3, 25%). Seven subjects died till the cut-off date, five of them died of disease progression and two of them died of COVID 19. In all patients (N = 12), the ORR was 25% and CRR was 8.3%. DL1 and DL2 patients benefited less from the therapy (ORR: 17%, N = 1; DCR: 33%, N = 2). However, all DL3 patients achieved disease control (N = 3, 100%), and all DL4 patients achieved objective response (N = 3, 100%).
Interpretation:
Our results demonstrate that CD19-CAR-DNT cells appear to be well tolerated with promising antitumor activity in LBCL patients. Further study of this product with a larger sample size is warranted. This phase 1 study is registered on clinicaltrials.gov (NCT05453669).
Funding:
Wyze Biotech. Co., Ltd.
2024-01-01EClinicalMedicine
Donor-derived Anti-CD19 CAR T cells GC007g for relapsed or refractory B-cell acute lymphoblastic leukemia after allogeneic HSCT: a phase 1 trial
Article
作者: Yang, Luxin ; Shen, Lianjun ; Li, Wenling ; Liu, Lizhen ; Huang, He ; Zhao, Lu ; Cao, W William ; Ye, Yishan ; Wang, Lu ; Wang, Dongrui ; Wang, Manning ; Gao, Lei ; Zhang, Xi ; Gao, Shichun ; Lai, Xiaoyu ; Liu, Jia ; Luo, Yi
Background:
Although chimeric antigen receptor-modified T cells (CAR T) cell therapy has been widely reported in improving the outcomes of B-cell acute lymphoblastic leukemia (B-ALL), less research about the feasibility and safety of donor-derived CAR T after allogeneic hematopoietic stem cell transplantation (allo-HSCT) was reported.
Methods:
This phase 1 clinical trial aims to evaluate safety and efficacy of donor-derived anti-CD19 CAR T cells (GC007g) in B-ALL patients who relapsed after allo-HSCT. This trial is registered with ClinicalTrials.gov, NCT04516551.
Findings:
Between 15 March 2021 and 19 May 2022, fifteen patients were screened, three patients were excluded due to withdraw of consent, donor's reason, and death, respectively. Patients received donor-derived CAR T cells infusions at 6 × 105/kg (n = 3) or 2 × 106/kg (n = 6) dose level. The median time from HSCT to relapse was 185 days (range, 81-2063). The median age of patients was 31 years (range 21-48). Seven patients (77.8%) had BCR-ABL fusion gene. CAR T cells expanded in vivo and the median time to reach Cmax was 9 days (range, 7-11). One patient had hyperbilirubinemia after GC007g infusion which was defined as a dose-limiting toxicity. All patients experienced CRS and hematological adverse events. Three patients had acute graft-versus-host-disease (grade I, n = 1; grade II, n = 1; grade IV, n = 1) and all resolved after treatment. They received CAR T cells from matched sister, haploidentical matched father and sisiter, respectively. At 28 days after infusion, all patients achieved complete remission with/without incomplete hematologic recovery (CRi/CR) with undetectable MRD. At a median follow-up of 475 days (range 322-732), seven patients remained in CR/CRi while two had CD19-negative relapse. The overall response rates (ORR) were 100% (9/9), 88.9% (8/9), and 75% (6/8) at 3 month, 6 month, and 12 month, respectively. The 1-year progression-free and overall survival were 77.8% and 85.7%, respectively.
Interpretation:
GC007g expanded and induced durable remission in patients with B-ALL relapsed after allo-HSCT, with manageable safety profiles.
Funding:
Gracell Biotechnologies Inc.
2023-07-13Blood
Allogeneic, donor-derived, second-generation, CD19-directed CAR-T cells for the treatment of pediatric relapsed/refractory BCP-ALL.
Article
作者: Pagliara, Daria ; Sinibaldi, Matilde ; Algeri, Mattia ; Del Bufalo, Francesca ; Rosignoli, Chiara ; Del Baldo, Giada ; Merli, Pietro ; Gunetti, Monica ; Quintarelli, Concetta ; Boccieri, Emilia ; Künkele, Annette ; Girolami, Elia ; Becilli, Marco ; Locatelli, Franco ; Li Pira, Giuseppina ; Bertaina, Valentina ; Lazzaro, Stefania ; Iaffaldano, Laura ; Di Cecca, Stefano ; Leone, Giovanna ; Hanssens, Linda ; Carta, Roberto ; De Angelis, Biagio ; Iacovelli, Stefano
Autologous CD19-directed chimeric antigen receptor (CAR)-T cells have shown unprecedented efficacy in children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL). However, patients either relapsing after allogeneic hematopoietic stem cell transplantation (allo-HSCT) or displaying profound lymphopenia and/or rapidly progressing disease often cannot access autologous products. These hurdles may be overcome by allogeneic, donor-derived CAR-T cells. We tested donor-derived T cells transduced with a second-generation (4.1BB) CD19-directed CAR for treatment of patients with BCP-ALL in a hospital-exemption setting. Two constructs were tested: a retroviral construct incorporating the suicide gene inducible caspase-9 (CD19-CAR-Retro_ALLO) first and then a lentiviral construct and an automated, Prodigy-based manufacturing process (CD19-CAR-Lenti_ALLO). Thirteen children/young adults received ALLO-CAR-T cells between March 2021 and October 2022. Doses ranged between 1.0 × 106 and 3.0 × 106 CAR-T cells per kg. The toxicity profile was comparable with that of autologous CAR-T cells, characterized mainly by cytopenia, cytokine release syndrome (maximum grade 1), and grade 2 immune-effector cell-associated neurotoxicity syndrome. One case of acute graft-versus-host disease (GVHD) occurred and was rapidly controlled with steroids and ruxolitinib. None of the other patients, including 3 given ALLO-CAR-T cells from an HLA-haploidentical donor, experienced GVHD. Two patients received ALLO-CAR-T cells before HSCT and showed a significant expansion of CAR-T cells without any sign of GVHD. All patients obtained complete remission (CR) with absence of minimal residual disease in the bone marrow. With a median follow-up of 12 months (range, 5-21), 8 of 13 patients maintained CR. Allogeneic anti-CD19 CAR-T cells can effectively treat highly refractory BCP-ALL relapsing after allo-HSCT without showing increased toxicity as compared with autologous CAR-T cells.
46
项与 GC007g 相关的新闻（医药）2024-08-08
细胞疗法免疫疗法ASH会议优先审批上市批准
2024-07-20
细胞疗法临床结果免疫疗法ASCO会议
2024-05-15
·药融圈
免疫疗法细胞疗法临床申请临床2期财报
100 项与 GC007g 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 |
|---|---|---|---|---|
| B淋巴细胞白血病淋巴瘤 | 临床2期 | 中国 | 2022-08-11 | |
| CD19阳性B细胞急性淋巴细胞白血病 | 临床2期 | 中国 | 2022-08-11 | |
| 复发性 B 细胞急性淋巴细胞白血病 | 临床2期 | 中国 | 2021-03-31 | |
| 难治性 B 细胞急性淋巴细胞白血病 | 临床2期 | 中国 | 2021-03-31 | |
| CD19 表达恶性肿瘤 | 临床1期 | 中国 | 2021-09-29 | |
| 复发性弥漫性大B细胞淋巴瘤 | 临床1期 | 中国 | 2020-11-20 | |
| 复发性成人急性淋巴细胞白血病 | 临床1期 | 中国 | 2020-11-20 |
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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1期 | 9 | GC007g 6 × 10^5/kg dose | 窪窪積淵窪憲築遞壓製(夢獵繭繭衊獵鏇淵醖顧) = 遞觸製艱憲鏇襯遞範淵 膚襯積築鏇窪壓醖簾範 (鏇齋鏇窪範積選憲築積 ) 更多 | 积极 | 2023-12-21 | ||
临床1期 | 12 | 鬱願憲衊製簾簾積糧鬱(積艱糧壓壓廠廠築觸構) = 鹹網獵衊鏇窪獵顧壓憲 鏇鏇膚蓋糧餘顧顧膚簾 (構鏇艱壓廠餘壓顧鹽窪 ) 更多 | - | 2023-06-08 |
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