药物类型 通用型CAR-T |
别名 Anti-CD7 Allogeneic CAR-T Cells(Wugen) + [2] |
靶点 |
作用机制 CD7调节剂(T细胞抗原CD7调节剂) |
非在研适应症- |
原研机构 |
非在研机构- |
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 |
特殊审评优先药物(PRIME) (欧盟)、罕见儿科疾病 (美国)、快速通道 (美国)、孤儿药 (美国)、再生医学先进疗法 (美国) |
开始日期2024-12-13 |
申办/合作机构 |
开始日期2023-10-10 |
申办/合作机构 |
开始日期2023-06-26 |
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 |
---|---|---|---|---|
难治性 T 急性淋巴细胞白血病 | 临床2期 | 中国 | 2024-03-29 | |
淋巴母细胞淋巴瘤 | 临床2期 | 法国 | 2022-01-14 | |
淋巴母细胞淋巴瘤 | 临床2期 | 美国 | 2022-01-14 | |
淋巴母细胞淋巴瘤 | 临床2期 | 澳大利亚 | 2022-01-14 | |
淋巴母细胞淋巴瘤 | 临床2期 | 荷兰 | 2022-01-14 | |
T细胞急性淋巴细胞白血病/淋巴瘤 | 临床2期 | 荷兰 | 2022-01-14 | |
T细胞急性淋巴细胞白血病/淋巴瘤 | 临床2期 | 澳大利亚 | 2022-01-14 | |
T细胞急性淋巴细胞白血病/淋巴瘤 | 临床2期 | 美国 | 2022-01-14 | |
T细胞急性淋巴细胞白血病/淋巴瘤 | 临床2期 | 法国 | 2022-01-14 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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临床1/2期 | 26 | (RP2D) | (蓋鬱蓋衊窪鹹淵齋艱壓) = 壓憲鹹鏇繭艱鹹築衊廠 窪艱鹹築夢積壓鬱遞築 (餘窪觸憲壓獵鹽窪製餘 ) 更多 | 积极 | 2024-08-05 | ||
临床1/2期 | 13 | (鏇糧衊獵構構襯蓋構積) = 築獵膚鹽憲選衊淵選觸 鬱艱積顧繭糧餘蓋繭艱 (鏇遞壓齋壓簾夢繭網範 ) 更多 | 积极 | 2024-05-14 | |||
N/A | - | (鹹顧艱憲衊齋觸簾壓蓋) = 鬱鏇鬱醖獵淵夢製糧觸 鹽淵獵鹹鏇選簾艱簾壓 (艱醖鬱鑰積遞鏇襯襯網 ) 更多 | - | 2024-05-14 | |||
(鹹顧艱憲衊齋觸簾壓蓋) = 觸範膚選壓鏇範襯鬱齋 鹽淵獵鹹鏇選簾艱簾壓 (艱醖鬱鑰積遞鏇襯襯網 ) 更多 | |||||||
临床1/2期 | 18 | (積簾願遞獵蓋簾壓淵顧) = 廠構蓋醖選積願夢齋夢 顧憲鹽廠廠選願範顧選 (遞獵繭遞築製廠憲蓋鏇 ) 更多 | 积极 | 2023-12-11 |