CTIS2023-507809-34-00招募中1 期
A Phase 1/2 Study of Linvoseltamab in Patients with Relapsed or Refractory Systemic Light Chain Amyloidosis - R5458-ONC-2274
Regeneron Pharmaceuticals Inc.0 个研究点目标入组 136 人开始时间: 2024年3月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of AL amyloidosis, as described in the protocol, Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol, Previously treated after at least 1 prior therapy and no more than 4 lines of therapy (including autologous stem cell transplant) and requiring further treatment as assessed by the Investigator, N-terminal pro b-type natriuretic peptide (NT-proBNP) =8500 ng/L during screening, Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol, Eastern Cooperative Oncology Group (ECOG) performance score =2 at screening, NOTE: Other protocol defined inclusion criteria apply
排除标准
- •History of other non-AL amyloidosis, Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening, Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening, Myocardial infarction within the past 6 months prior to the first screening visit, Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug, NOTE: Other protocol defined exclusion criteria apply
研究者
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