NCT07079423招募中2 期
Teclistamab for Newly Diagnosed Mayo Stage IIIB Light-chain Amyloidosis Patients, a Phase II Study
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation
研究概览
简要总结
This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmed AL amyloidosis
- •Mayo 2004 stage IIIB
- •dFLC ≥ 50mg/L
排除标准
- •Co-morbidity of uncontrolled infection
- •Co-morbidity of other active malignancy
- •Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
- •Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
- •Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
- •Seropositive for human immunodeficiency virus
- •Hepatitis B virus (HBV)-DNA > 1000 copies/mL
- •Seropositive for hepatitis C (except in the setting of a sustained virologic response)
- •Neutrophil <1×10E9/L, hemoglobin < 8g/dL, or platelet < 75×10E9/L.
- •Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) > 5 × upper limit of normal (ULN), total bilirubin > 2 × ULN, estimated glomerular filtration rate < 20 mL/min, or receiving renal replacement therapy
研究组 & 干预措施
Teclistamab
Experimental
Teclistamab will be administered via a subcutaneous injection
干预措施: Teclistamab (Tec) (Drug)
结局指标
主要结局
Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation
时间窗: at 1 months after treatment initiation
Stringent dFLC response is defined as dFLC \< 10 mg/L or involved free light chain (FLC) ≤ 20 mg/L, and FLC will be tested using FreeLite assay (Binding Site).
次要结局
未报告次要终点
研究者
Kaini Shen
Professor
Peking Union Medical College Hospital
研究点 (1)
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