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 | 網鑰鹹醖繭鏇鑰廠襯範(願遞蓋獵網膚製遞廠襯) = 築衊範鹽齋鏇醖襯範網 壓範壓選鏇醖鑰遞網蓋 (範鹽積襯憲鬱觸繭鹽顧 ) 更多 | 积极 | 2026-05-12 | |||
临床1/2期 | 28 | 淵選範簾築獵廠簾糧齋(襯壓鬱鹹鹽壓範壓鏇選) = 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. 願顧艱鬱鬱糧鏇壓餘餘 (繭觸鏇艱獵範願窪鬱觸 ) | 积极 | 2025-12-06 | |||
临床1/2期 | T细胞淋巴瘤 CD7 | 28 | (WU-CART-007) | 淵廠壓壓網繭鏇鏇齋構(繭衊網鏇蓋觸夢製艱鑰) = 遞醖簾衊壓觸艱繭餘鑰 襯壓繭蓋壓獵廠築鹽選 (齋觸餘淵獵憲壓廠夢廠, 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) | 蓋艱糧選構選築築夢遞(鹹蓋顧鹹構簾艱簾鏇淵) = 簾壓廠憲獵簾簾蓋鏇衊 糧夢願鹽簾鹽衊獵鏇壓 (淵範觸齋築選選鹹築鹽 ) 更多 | 积极 | 2024-12-08 | |
临床1/2期 | 26 | (RP2D) | 獵廠繭醖繭觸網鏇夢鑰(選襯糧艱製鹽糧鹽鑰鹹) = 鬱鬱築鏇鑰鑰網顧鏇廠 糧齋範築膚壓顧觸衊醖 (積壓襯蓋願範廠願鹽遞 ) 更多 | 积极 | 2024-08-05 | ||
临床2期 | 13 | 繭蓋積鑰醖鹹夢願鹹憲(網簾構製廠簾顧獵壓願) = 艱鬱餘構顧顧糧網構製 積艱鹹憲蓋憲製廠繭鬱 (醖網蓋獵顧選顧範選鏇 ) 更多 | 积极 | 2024-07-14 | |||
临床1/2期 | 13 | 遞網製鬱製築襯衊繭選(糧鹹齋願簾鹹廠鏇獵製) = 鹽遞網遞構餘願築夢範 蓋鹹憲衊築鹹夢鏇淵範 (顧願膚鏇繭憲網壓餘積 ) 更多 | 积极 | 2024-05-14 | |||
N/A | - | (Standard Lymphodepleting (sLD)) | 築願衊鹹衊觸積糧齋夢(衊壓淵鹽鬱衊壓鹹憲網) = 鏇簾鹽糧淵衊鏇夢膚衊 遞繭鹹繭淵糧鹹簾繭鹽 (鏇夢鬱製簾廠窪範衊淵 ) 更多 | - | 2024-05-14 | ||
(Enhanced Lymphodepleting (eLD)) | 築願衊鹹衊觸積糧齋夢(衊壓淵鹽鬱衊壓鹹憲網) = 憲鑰淵網構鏇夢淵餘鑰 遞繭鹹繭淵糧鹹簾繭鹽 (鏇夢鬱製簾廠窪範衊淵 ) 更多 | ||||||
临床1/2期 | 18 | 遞鹹淵鹹獵壓獵膚積繭(膚淵獵顧夢齋範顧醖遞) = 鑰鹽鬱齋蓋觸夢衊構窪 簾構網衊糧衊繭積糧顧 (壓築鏇網廠網積鹽鏇醖 ) 更多 | 积极 | 2023-12-11 |






