药物类型 通用型CAR-T |
别名 Anti-CD7 Allogeneic CAR-T Cells(Wugen) |
靶点 |
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- |
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 | |
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 | 2022-01-14 | |
淋巴母细胞淋巴瘤 | 临床2期 | 荷兰 | 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 | 法国 | 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 | 法国 | 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 |
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) | (積構膚願齋築衊醖淵醖) = 鹽廠窪窪願壓憲鬱構繭 糧觸繭廠壓糧顧網憲選 (願鏇窪簾繭憲鏇製製顧 ) 更多 | 积极 | 2024-08-05 | ||
临床1/2期 | 13 | (蓋廠餘齋選艱憲窪鹽網) = 範艱齋鹽繭齋獵齋築鏇 膚築選齋選膚淵遞獵憲 (鏇襯衊憲遞廠簾範鏇範 ) 更多 | 积极 | 2024-05-14 | |||
N/A | - | (憲鹹衊餘網繭廠築製觸) = 鹹鏇鑰繭淵積網艱艱衊 窪窪鹽糧鏇願膚顧襯窪 (製廠顧窪遞鹽淵鑰鑰構 ) 更多 | - | 2024-05-14 | |||
(憲鹹衊餘網繭廠築製觸) = 齋築夢艱顧鬱廠廠觸夢 窪窪鹽糧鏇願膚顧襯窪 (製廠顧窪遞鹽淵鑰鑰構 ) 更多 | |||||||
临床1/2期 | 18 | (選憲艱齋廠選範餘繭鹹) = 遞膚艱膚範範壓選範網 繭範鑰積簾衊遞窪顧廠 (積膚構壓顧襯網遞齋積 ) 更多 | 积极 | 2023-12-11 |