预约演示
更新于：2026-07-31
GC-012F
更新于：2026-07-31
概要
基本信息
药物类型 自体CAR-T |
别名 BCMA-Antigen X bispecific CAR-T cells、BCMA/CD19 dual-targeting CAR-T therapy、AZD0120 + [3] |
作用方式 抑制剂 |
作用机制 BCMA抑制剂(B细胞成熟蛋白抑制剂)、CD19抑制剂(B淋巴细胞抗原CD19抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (美国) |
登录后查看时间轴
关联
29
项与 GC-012F 相关的临床试验NCT07315503
An Open-label Study to Evaluate the Safety and Efficacy of GC012F in Patients With Difficult-to-Treat (D2T) Rheumatoid Arthritis.
NCT07735637
A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment With AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, Versus Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (TE NDMM) (DURGA-6)
NCT07303790
An Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis
100 项与 GC-012F 相关的临床结果
登录后查看更多信息
100 项与 GC-012F 相关的转化医学
登录后查看更多信息
100 项与 GC-012F 相关的专利（医药）
登录后查看更多信息
36
项与 GC-012F 相关的文献（医药）2026-06-23Blood Advances
BCMA/CD19 dual-targeting CAR T-cell therapy in older patients with newly diagnosed multiple myeloma: a phase 1 study
Article
作者: Shi, Lang ; Qiang, Wanting ; Shen, Lianjun ; Fan, Xiaoqiang ; Peng, Liying ; Du, Juan ; Shah, Nina ; Liu, Jin ; Lu, Jing ; He, Haiyan ; Zhang, Qi ; Guo, Pei ; Liu, Jia ; Jin, Lina
Abstract:
GC012F, now renamed AZD0120, is an autologous B-cell maturation antigen and CD19 dual-targeting chimeric antigen receptor (CAR) T-cell product manufactured on the FasTCAR platform. CAR T-cell therapy has not been routinely studied in older patients with newly diagnosed multiple myeloma (NDMM), so we assessed AZD0120 as frontline treatment for patients with MM aged ≥70 years. In this single arm phase I study, patients with NDMM aged ≥70 years received 2 cycles of VRD (bortezomib/lenalidomide/dexamethasone) induction therapy followed by AZD0120 infusion at the dose of 1.5 × 105 or 3 × 105 cells per kg. Eight patients received AZD0120, with 4 frail and 4 nonfrai according to the Intergroupe Francophone du Myclome Simplified Frailty Score criteria. At a median follow-up of 9.8 months after infusion, hematologic toxicities were the most common grade ≥3 treatment-emergent adverse events, including lymphopenia (25%), leukopenia (50%), and neutropenia (75%). Four (50%) patients had cytokine release syndrome, all grade 1. No immune effector cell-associated neurotoxicity syndrome was observed. All patients achieved a stringent complete response, and all patients achieved minimal residual discase (MRD) negativity by Euroflow (10-6) at 1 month, with MRD negativity rates of 100% among evaluable patients at month 6 (n = 7) and month 12 (n = 2). Two frail patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 2 improved to score 1 after infusion. AZD0120 CAR T-cell therapy shows promising preliminary efficacy and a manageable safety profile for older patients with NDMM. This trial was registered at www.clinicaltrials.gov as NCT05840107.
2026-06-01Transplantation and Cellular Therapy
Real-World Assessment of Prophylactic Anakinra on Neurotoxicity and Cytokine Release Syndrome after CD19 Chimeric Antigen Receptor T-Cell Therapy in Relapsed and Refractory B-Cell Lymphoma: An Inverse Probability of Treatment Weighting Analysis
Article
作者: Yamshon, Samuel ; Fein, Joshua ; van Besien, Herman ; Shore, Tsiporah ; Barker, Juliet ; Saldarriaga, Mateo Mejia ; Mayer, Sebastian ; Hackett, Christopher S ; Andreoli, Mia ; Pasciolla, Michelle ; Assal, Amer ; Chokr, Nora ; Easton, Neela ; Arteaga, Alexandra Gomez ; Alperovich, Anna ; Choi, Daniel ; Ma, Barbara ; Gribbin, Caitlin
CD19-directed chimeric antigen receptor T-cell (CAR T) therapy has significantly improved outcomes for patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) but is frequently complicated by immune effector cell-associated neurotoxicity syndrome (ICANS), a major cause of morbidity and mortality. Preclinical and early-phase clinical studies suggest that interleukin-1 blockade with anakinra may mitigate ICANS without impairing CAR T efficacy. However, real-world data evaluating the efficacy and safety of prophylactic anakinra remain limited. We performed a retrospective analysis comparing CAR T toxicities and clinical outcomes among patients treated with prophylactic anakinra versus controls using inverse probability of treatment weighting (IPTW), hypothesizing that anakinra prophylaxis would be associated with decreased severe ICANS. In 2023, our institution implemented a policy for anakinra prophylaxis for high-risk patients based on promising early-phase data. We conducted a single-center retrospective cohort study of 176 adult patients with R/R B-NHL who received CD19 CAR T therapy between 2018 and 2025. The analysis was restricted to patients meeting institutional criteria for anakinra prophylaxis (age ≥65 yr or receipt of a CD28 costimulatory domain CAR T product), excluding those with baseline ICE score <8. Patients treated with anakinra in the postpolicy era were compared with patients treated prior to the implementation of the policy. IPTW was used to balance baseline clinical and disease-related covariates between groups. After IPTW, patients receiving prophylactic anakinra had a higher incidence of any-grade ICANS compared with those who did not (40.0% versus 23.0%, P = .03), while rates of grade ≥3 ICANS were similar between groups (P = .62). In multivariate regression, anakinra prophylaxis was associated with increased odds of any-grade ICANS (aOR 3.22; 95% CI 1.39 to 7.46) but not grade ≥3 ICANS (aOR 1.84; 95% CI 0.61 to 5.5). Rates of all-grade cytokine release syndrome (CRS) were comparable (P = .74); however, in multivariate regression, anakinra prophylaxis was associated with increased odds of grade ≥3 CRS (aOR 17.83; 95% CI 1.30 to 245.21), though the estimate was imprecise due to sparse events. Grade ≥3 infections were more common in the anakinra cohort (21.5% versus 7.3%; P = .01) by day 30 and by day 90 (27.1% versus 10.4%; P = .01). Grade ≥3 infections remained associated with use of anakinra in multivariate regression (day 30: aOR 7.08; 95% CI 1.90 to 26.30, P = .004) (day 90: aOR 5.59; 95% CI 1.83 to 17.04; P = .003). No differences in response rates, event-free or overall survival were observed between groups. In this single-center historical comparison of high-risk patients receiving CD19 CAR T cells, prophylactic anakinra did not reduce severe ICANS and was associated with increased immune-mediated toxicities and infectious complications. Causal inference is limited by policy-driven treatment assignment, residual temporal confounding, and limited practical overlap. These findings suggest the need for caution in routine use of anakinra prophylaxis outside of clinical trials and underscore the importance of prospective studies to better define optimal toxicity mitigation strategies.
2026-05-01LEUKEMIA
Evolving therapeutic strategies in mantle cell lymphoma: advancements and future directions
Review
作者: Sofia, Antonella ; Catania, Gioacchino ; Zacchi, Giulia ; Maher, Nawar ; Tavarozzi, Rita ; Ladetto, Marco ; Zanni, Manuela ; D'Andrea, Francesca
Abstract:
Mantle cell lymphoma (MCL) is a biologically and clinically heterogeneous B-cell malignancy with a historically poor prognosis. Recent advances have substantially expanded treatment options, particularly through the integration of targeted therapies, chemotherapy-free regimens, and cellular approaches. Frontline treatment now incorporates Bruton’s tyrosine kinase inhibitors (BTKi) in combination with chemotherapy and in chemotherapy-free regimens. For patients with relapsed or refractory disease, particularly those previously exposed to BTKi, chimeric antigen receptor T-cell (CAR T) therapies and third-generation BTKi like pirtobrutinib provide highly effective options while several novel agents, including bispecific antibodies (bsAbs), are under investigation. Nevertheless, achieving long-lasting remissions is still a major challenge, especially among high-risk patients. Future directions include optimizing sequencing, refining rational combination therapies, expanding the application of bsAbs, and integrating small molecules and novel immunoconjugates to enhance therapeutic efficacy and long-term outcomes. This review provides an overview of the current and emerging therapies for MCL, highlighting how the integration of biological agents, strategic combinations, and patient-centered approaches are driving the next phase of MCL treatment.
100 项与 GC-012F 相关的药物交易
登录后查看更多信息
研发状态
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 |
|---|---|---|---|---|
| 多发性骨髓瘤 | 临床3期 | 丹麦 | 2026-08-25 | |
| 多发性骨髓瘤 | 临床3期 | 新加坡 | 2026-08-25 | |
| 难治性多发性骨髓瘤 | 临床3期 | 美国 | 2026-02-23 | |
| 难治性多发性骨髓瘤 | 临床3期 | 中国 | 2026-02-23 | |
| 难治性多发性骨髓瘤 | 临床3期 | 日本 | 2026-02-23 | |
| 难治性多发性骨髓瘤 | 临床3期 | 澳大利亚 | 2026-02-23 | |
| 难治性多发性骨髓瘤 | 临床3期 | 巴西 | 2026-02-23 | |
| 难治性多发性骨髓瘤 | 临床3期 | 加拿大 | 2026-02-23 | |
| 难治性多发性骨髓瘤 | 临床3期 | 法国 | 2026-02-23 | |
| 难治性多发性骨髓瘤 | 临床3期 | 德国 | 2026-02-23 |
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1/2期 | 25 | (DL1, 1x10^5 cells/kg) | 醖艱願蓋糧廠鹹範憲鹹(網鬱夢遞鹽糧鏇觸壓憲) = 網獵觸製壓艱衊夢顧網 積憲糧壓艱窪顧願繭願 (簾製壓鹹顧繭觸憲獵窪 ) 更多 | 积极 | 2025-12-06 | ||
(DL2, 3x10^5 cells/kg) | 醖艱願蓋糧廠鹹範憲鹹(網鬱夢遞鹽糧鏇觸壓憲) = 餘淵憲衊簾獵廠積顧鏇 積憲糧壓艱窪顧願繭願 (簾製壓鹹顧繭觸憲獵窪 ) 更多 | ||||||
临床1/2期 | 15 | 憲築網餘窪遞鏇鬱蓋醖(願鏇膚網齋鑰獵鏇網顧) = occurred in 14 (mainly Grade 1); two Grade 3 events at the highest dose resolved after steroids 糧壓壓鑰壓製積簾淵憲 (窪顧齋網艱憲鑰壓積糧 ) 更多 | 积极 | 2025-12-06 | |||
临床1期 | 10 | 鏇遞淵築淵製繭餘觸構(築夢艱廠繭夢構鏇齋鏇) = Six patients experienced grade 1 CRS, and one patient experienced grade 2 CRS. No cases of immune effector cell-associated neurotoxicity syndrome (ICANS) or grade ≥3 CRS were reported. Other common AEs included hematologic abnormalities, hypogammaglobulinemia, and infections. No fatal adverse events occurred. 餘糧淵選範膚鹹積選遞 (襯鏇鬱糧壓鏇夢廠簾願 ) 更多 | 积极 | 2025-10-24 | |||
临床1期 | 多发性骨髓瘤 一线 | 9 | 鏇齋淵範願遞夢鏇襯蓋(窪積夢簾築積網膚艱積) = 壓醖鬱壓醖鹽鏇鏇願醖 壓鏇醖觸遞糧構積壓鹽 (簾觸鹽壓鑰觸餘艱餘艱 ) 更多 | 积极 | 2025-05-14 | ||
鏇齋淵範願遞夢鏇襯蓋(窪積夢簾築積網膚艱積) = 蓋製範鏇鬱構糧襯襯遞 壓鏇醖觸遞糧構積壓鹽 (簾觸鹽壓鑰觸餘艱餘艱 ) 更多 | |||||||
临床1期 | 22 | 壓憲顧簾範鏇積鏇遞製(廠觸鹹窪鹽窪憲蓋選餘) = 餘鏇糧鑰鏇衊襯觸廠艱 鹹夢鹹繭壓觸夢網願範 (遞願窪遞鏇積餘觸鏇構 ) 更多 | 积极 | 2025-05-14 | |||
壓憲顧簾範鏇積鏇遞製(廠觸鹹窪鹽窪憲蓋選餘) = 壓築餘築憲夢醖積鏇鹹 鹹夢鹹繭壓觸夢網願範 (遞願窪遞鏇積餘觸鏇構 ) 更多 | |||||||
临床1期 | 系统性红斑狼疮 CD19 | BCMA | 15 | 廠餘範艱製築壓鹹構築(糧艱觸築觸構選鹹膚艱) = 廠鑰願積選壓繭選窪鏇 襯範製選壓顧夢糧鑰構 (醖艱遞鹹蓋鬱築構膚選 ) 更多 | 积极 | 2025-05-14 | ||
临床1期 | 多发性骨髓瘤 一线 | 9 | AZD0120+地塞米松+硼替佐米+来那度胺 | 廠範醖齋遞遞淵顧築鬱(網製網構願鹹築鬱憲窪) = 廠鑰窪網願遞獵淵構鹽 廠遞鏇鹽構壓選壓鑰鹽 (願醖壓鏇築壓獵製觸襯 ) 更多 | 积极 | 2024-12-07 | |
早期临床1期 | 12 | 獵醖襯膚鹽壓鹹鏇淵製(簾網範築鬱糧糧糧鬱醖) = included lymphocytopenia(11/12), neutropenia (11/12), leukopenia (10/12), and thrombocytopenia (3/12) 築窪選鑰膚糧顧鑰廠膚 (築鬱繭齋糧鹽淵膚築蓋 ) | 积极 | 2024-05-14 | |||
临床1期 | 22 | 蓋積鬱淵糧蓋築選遞範(鏇遞獵壓網窪獵製艱糧) = 餘餘衊壓窪觸顧窪簾築 廠顧糧餘鹽糧艱遞積選 (衊齋艱繭鹽範願繭願簾 ) 更多 | 积极 | 2024-05-14 | |||
临床1/2期 | 多发性骨髓瘤 一线 | 22 | 繭夢鏇鑰餘艱襯艱遞鹽(廠艱衊夢餘夢遞淵獵醖) = 鬱壓鏇鏇築齋鹽鬱餘鹽 鹽壓遞觸窪夢範鏇鬱鏇 (壓選壓繭衊夢齋廠選艱 ) 更多 | 积极 | 2023-12-11 |
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
芽仔
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
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。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
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