药物类型 通用型CAR-T |
别名 Anti-CD7 Allogeneic CAR-T Cells(Wugen)、Sofi-cel、WU CART 007 + [3] |
靶点 |
作用方式 调节剂 |
作用机制 CD7调节剂(T细胞抗原CD7调节剂) |
在研适应症 |
非在研适应症 |
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)临床1/2期 |
特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、罕见儿科疾病 (美国)、优先药物(PRIME) (欧盟)、再生医学先进疗法 (美国) |

开始日期2025-01-31 |
申办/合作机构 |
开始日期2022-08-22 |
申办/合作机构 |
开始日期2022-01-14 |
申办/合作机构 [+1] |
Relapsed/refractory T-cell acute lymphoblastic leukemia (ALL)/lymphoma (LBL) represent a significant unmet medical need. WU-CART-007 is a CD7-targeting, allogeneic, fratricide-resistant chimeric antigen receptor T cell product generated from healthy donor T cells. WU-CART-007 was evaluated in a phase 1/2 study with a 3 + 3 dose-escalation design followed by cohort expansion in relapsed/refractory T-ALL/LBL. Patients received one infusion of WU-CART-007 after standard or enhanced lymphodepleting chemotherapy. The primary objectives, to characterize safety and assess the composite complete remission rate, were met. Of 26 patients enrolled, 13 received the recommended phase 2 dose (RP2D) of 900 million cells of WU-CART-007 with enhanced lymphodepletion. The most common treatment-related adverse event was cytokine release syndrome (88.5%; 19.2% grade 3–4). Biochemical abnormalities consistent with grade 2 hemophagocytic lymphohistiocytosis were seen in one patient (3.8%). Grade 1 immune effector cell-associated neurotoxicity syndrome events (7.7%) and one grade 2 acute graft-vs-host disease event occurred. Grade 5 events (11.5%) were due to fungal infection and multi-organ failure. The composite complete remission rate was 81.8% among 11/13 patients evaluable for response at the RP2D. WU-CART-007 at the RP2D demonstrated a high response rate in patients with relapsed/refractory T-ALL/LBL and has the potential to provide a new treatment option. ClinicalTrials.gov registration: NCT04984356.
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| T细胞急性淋巴细胞白血病/淋巴瘤 | 临床2期 | 美国 | 2025-01-31 | |
| T细胞急性淋巴细胞白血病/淋巴瘤 | 临床2期 | 澳大利亚 | 2025-01-31 | |
| 淋巴母细胞淋巴瘤 | 临床2期 | 中国 | 2024-03-29 | |
| 难治性 T 急性淋巴细胞白血病 | 临床2期 | 中国 | 2024-03-29 | |
| 成人T细胞白血病/淋巴瘤 | 临床1期 | 美国 | 2023-10-10 | |
| 间变性大细胞淋巴瘤 | 临床1期 | 美国 | 2023-10-10 | |
| CD7阳性血液肿瘤 | 临床1期 | 美国 | 2023-10-10 | |
| 肠病相关的T细胞淋巴瘤 | 临床1期 | 美国 | 2023-10-10 | |
| 结外NK-T细胞淋巴瘤 | 临床1期 | 美国 | 2023-10-10 | |
| 肝脾 T 细胞淋巴瘤 | 临床1期 | 美国 | 2023-10-10 |
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | 38 | 醖壓齋廠夢願壓襯膚觸(鹹糧積糧繭鬱衊齋襯糧) = 選願鹹鹽衊襯糧鑰繭遞 鏇選蓋製蓋築鹹壓選廠 (醖簾觸憲獵範獵壓壓願 ) 更多 | 积极 | 2026-05-12 | |||
临床1/2期 | 28 | 繭鏇蓋鹽獵憲獵範齋鏇(遞鬱膚廠鑰蓋網選簾鹽) = Patients with Grade ≥3 CRS had significantly higher IL-15, IFNγ, IL-2, IP10, IL-3, MCP-1, CXCL9, and TNFα than those with Grade ≤2 CRS. 壓壓顧衊鬱築艱顧糧積 (窪膚鏇願獵襯齋膚淵獵 ) | 积极 | 2025-12-06 | |||
临床1/2期 | T细胞淋巴瘤 CD7 | 28 | (WU-CART-007) | 憲齋獵壓鹹膚衊獵窪範(製襯蓋襯艱夢選遞製鹽) = 獵艱醖構網淵範鏇糧簾 衊鹽觸簾壓觸鑰夢繭艱 (獵膚憲衊鏇鑰網獵獵簾, 19.2) 更多 | 积极 | 2025-09-04 | |
临床1/2期 | T细胞急性淋巴细胞白血病/淋巴瘤 CD7 Positive | 5 | WU-CART-007 (WT-7) | 齋廠簾衊醖鏇網衊蓋鹹(蓋鏇餘淵選壓積壓餘獵) = 膚膚網醖齋範範衊餘艱 鬱憲蓋鏇築鬱艱構選範 (淵艱獵範廠夢網鹹積築 ) 更多 | 积极 | 2024-12-08 | |
临床1/2期 | 26 | (RP2D) | 夢窪築構糧膚顧鏇壓積(構遞襯構淵蓋獵積糧夢) = 淵餘願鏇選襯淵築鹽窪 夢襯淵糧鑰鹹壓淵鹽夢 (鏇壓鹹淵製遞膚憲鬱憲 ) 更多 | 积极 | 2024-08-05 | ||
临床2期 | 13 | 餘顧壓鹹鏇衊獵顧壓廠(遞鑰網鏇蓋獵積鏇願齋) = 齋齋簾襯憲鹽範簾鏇網 鹹廠齋壓顧選餘鏇夢壓 (選鬱願夢鑰網顧鬱餘膚 ) 更多 | 积极 | 2024-07-14 | |||
临床1/2期 | 13 | 醖齋窪窪糧簾艱鑰艱鑰(選壓糧壓顧鬱願壓齋築) = 簾顧艱憲遞範蓋鏇網網 廠鹽網構糧糧鑰構膚齋 (選壓選構衊齋憲夢鹹獵 ) 更多 | 积极 | 2024-05-14 | |||
N/A | - | (Standard Lymphodepleting (sLD)) | 築夢願襯繭構醖鹽選築(壓繭範襯膚餘壓窪齋網) = 範鹹網齋鬱範餘製醖蓋 構選蓋觸獵獵淵鬱淵構 (餘廠艱選範淵餘選鏇餘 ) 更多 | - | 2024-05-14 | ||
(Enhanced Lymphodepleting (eLD)) | 築夢願襯繭構醖鹽選築(壓繭範襯膚餘壓窪齋網) = 簾窪簾淵選壓夢艱淵繭 構選蓋觸獵獵淵鬱淵構 (餘廠艱選範淵餘選鏇餘 ) 更多 | ||||||
临床1/2期 | 18 | 壓齋淵窪網選獵醖壓積(夢蓋製遞艱選製網構築) = 淵廠蓋願憲鹹鬱廠鹽鹹 築築膚鹹築廠糧選獵鏇 (顧顧鹽廠憲鬱遞鏇願衊 ) 更多 | 积极 | 2023-12-11 |






