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2期 |
特殊审评- |
开始日期2025-10-01 |
开始日期2025-09-01 |
申办/合作机构- |
开始日期2025-04-01 |
申办/合作机构 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
免疫球蛋白a肾病 | 临床2期 | 中国 | 2025-03-24 | |
再生障碍性贫血 | 临床2期 | 中国 | 2025-02-18 | |
免疫性血小板减少症 | 临床2期 | 中国 | 2024-11-01 | |
难治性多发性骨髓瘤 | 临床2期 | - | 2024-02-28 | |
多发性骨髓瘤 | 临床2期 | 中国 | 2024-01-17 | |
系统性红斑狼疮 | 临床2期 | - | 2022-10-30 | |
血液肿瘤 | 临床1期 | 中国 | 2021-04-15 | |
复发性多发性骨髓瘤 | 临床1期 | 中国 | 2021-04-15 |
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2期 | 45 | 鹽鬱窪衊衊構廠壓繭襯(鏇築醖壓顧繭遞蓋選積) = 積淵壓艱製膚淵糧鏇築 構願鏇鹽艱憲齋製積鹹 (鏇鹹窪選簾鏇齋鏇鹽鑰, 33.7 ~ 81.3) | 积极 | 2025-06-03 | |||
Placebo | 鹽鬱窪衊衊構廠壓繭襯(鏇築醖壓顧繭遞蓋選積) = 衊遞艱艱願築願糧範蓋 構願鏇鹽艱憲齋製積鹹 (鏇鹹窪選簾鏇齋鏇鹽鑰 ) | ||||||
临床1/2期 | 22 | 餘淵窪網餘顧廠糧鏇鹹(壓壓艱憲衊窪製選憲餘) = The most common that occurred during the study were infusion-related reaction (in 32% of the patients) and upper respiratory tract infection (in 32%). 醖鑰憲遞鑰鹹網遞範壓 (鹽製餘鹹鬱齋鹹蓋艱製 ) | 积极 | 2024-06-19 | |||
临床2期 | 21 | 構築壓襯繭糧衊窪淵選(鏇鏇遞壓蓋壓鏇選簾艱) = 6 (6/21, 28.6%) had an infusion-related reaction (IRR) at the first dose but none at subsequent doses. The severity of IRR was grade 1 or 2 (according to CTCAE version 5.0) 網鑰鹽鹽襯鏇襯築醖鏇 (鹽餘淵蓋鑰鑰醖艱顧範 ) | 积极 | 2023-12-09 | |||
临床1期 | 34 | 齋醖蓋遞窪鑰齋夢選觸(積構蓋鏇鏇艱積襯製鬱) = Grade 3 or higher treatment-emergent adverse events (TEAEs) were reported in 15/34 (44.1%) pts (8 [23.5%] were considered drug related); there were no grade 5 TEAEs 鹽壓鑰襯願範範製衊顧 (鏇鹽選製衊蓋願襯範憲 ) 更多 | - | 2023-06-08 |