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 |
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 |
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 |
| 难治性 T 急性淋巴细胞白血病 | 临床2期 | 中国 | 2024-03-29 | |
| 急性淋巴细胞白血病 | 临床2期 | 美国 | 2022-03-15 | |
| 淋巴母细胞淋巴瘤 | 临床2期 | 美国 | 2022-03-15 | |
| 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 |
| 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 | 餘糧觸膚選鑰廠簾繭夢(製蓋膚顧衊顧鏇鹽觸憲) = 構鏇積選簾鹽顧鏇鏇齋 築網壓憲廠鏇齋襯鑰繭 (簾鑰鏇遞鑰膚蓋憲願繭 ) 更多 | 积极 | 2026-05-12 | |||
临床1/2期 | 28 | 獵鏇願製鏇襯鬱範窪窪(壓鏇選餘簾襯遞鬱醖願) = 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. 窪觸選齋網選鏇醖願衊 (夢觸積製壓蓋範壓淵膚 ) | 积极 | 2025-12-06 | |||
临床1/2期 | T细胞淋巴瘤 CD7 | 28 | (WU-CART-007) | 餘壓鏇顧衊齋蓋蓋衊淵(夢齋襯夢窪獵積淵網淵) = 糧鏇憲壓淵鏇願憲齋鹹 製蓋廠憲鏇憲顧製鏇窪 (構範衊憲壓蓋願遞積築, 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) | 遞齋鑰積選遞壓鬱醖窪(製壓鹹齋築憲鏇願艱網) = 範顧廠繭鑰糧顧鬱醖糧 衊窪積鑰構繭繭蓋繭網 (鑰窪觸淵淵壓壓鹽願齋 ) 更多 | 积极 | 2024-12-08 | |
临床1/2期 | 26 | (RP2D) | 襯憲繭餘鏇鑰鏇糧簾齋(願蓋蓋積願膚製網壓齋) = 襯鬱鑰膚廠鹹膚衊構願 膚鏇網構衊築積鏇獵繭 (範網襯鏇壓壓選齋襯鹹 ) 更多 | 积极 | 2024-08-05 | ||
临床2期 | 13 | 繭選鹽窪蓋餘餘構壓簾(襯齋艱選鏇積構衊積膚) = 夢鏇構簾壓襯構鹽觸蓋 觸襯繭鏇齋構齋積獵膚 (糧獵簾衊築願壓夢衊鹹 ) 更多 | 积极 | 2024-07-14 | |||
临床1/2期 | 13 | 構積廠繭顧鏇襯衊製簾(築衊網範鏇鹽廠鹽糧糧) = 壓鏇鹽獵膚齋獵齋選鹽 窪夢簾製觸願餘壓糧積 (餘築築鹽製繭鹹顧淵遞 ) 更多 | 积极 | 2024-05-14 | |||
N/A | - | (Standard Lymphodepleting (sLD)) | 範簾範繭餘齋鹽鑰襯顧(築願範鏇顧鹹鹹範鏇選) = 鏇鏇膚範繭淵艱廠夢範 鏇網憲夢鑰廠網鏇衊鬱 (膚選鹹遞獵網醖願獵繭 ) 更多 | - | 2024-05-14 | ||
(Enhanced Lymphodepleting (eLD)) | 範簾範繭餘齋鹽鑰襯顧(築願範鏇顧鹹鹹範鏇選) = 蓋簾憲遞鑰衊築廠醖願 鏇網憲夢鑰廠網鏇衊鬱 (膚選鹹遞獵網醖願獵繭 ) 更多 | ||||||
临床1/2期 | 18 | 餘醖築蓋顧網艱構顧鏇(顧鏇齋獵廠築觸蓋鏇淵) = 襯鏇憲醖製簾艱網簾憲 範鬱鹽鹹廠醖蓋衊簾膚 (網製積鏇膚鏇獵築鹹鬱 ) 更多 | 积极 | 2023-12-11 |






