NCT07039578招募中2 期
An Open-Label, Multi-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Relapsed or Refractory Primary Light-Chain Amyloidosis
Keymed Biosciences Co.Ltd2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7月25日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy after CM336 treatment
研究概览
简要总结
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Voluntary provision of written informed consent and ability to comply with protocol requirements.
- •Age ≥18 years, any gender.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •Confirmed diagnosis of primary light-chain (AL) amyloidosis.
- •Relapsed or refractory primary AL amyloidosis.
- •Measurable hematologic disease at screening (per protocol-defined criteria).
- •Involvement of ≥1 amyloid-affected organ.
- •Adequate organ function meeting all protocol-specified criteria within 3 days prior to first dose.
排除标准
- •Current or prior diagnosis of multiple myeloma.
- •Received anti-AL amyloidosis therapy within protocol-specified timeframe prior to first dose.
- •Clinically significant cardiovascular or cerebrovascular disease.
- •Any active or uncontrolled infection meeting protocol-defined criteria.
- •Any other condition deemed by the Investigator to preclude safe study participation.
研究组 & 干预措施
Low dose group(CM336)
Experimental
干预措施: CM336 Injection(Low dose group) (Biological)
High dose group(CM336)
Experimental
干预措施: CM336 Injection(High dose group) (Biological)
结局指标
主要结局
To evaluate the efficacy after CM336 treatment
时间窗: up to 3 years
Hematologic complete response (hCR) rate
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
A Study to Evaluate CM336 in Adults With Autoimmune Bullous DiseaseNCT06900010Shandong First Medical University30
招募中
不适用
BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple MyelomaHigh Risk Smoldering Multiple MyelomaNCT06745687Institute of Hematology & Blood Diseases Hospital, China20
招募中
2 期
An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune ThrombocytopeniaNCT06799611Institute of Hematology & Blood Diseases Hospital, China20
尚未招募
不适用
BCMA/CD3 BiTE for RRAL or NDAL Amyloidosis With Insufficient Depth of Hematologic Response After Induction TherapyAL AmyloidosisNCT06769555Institute of Hematology & Blood Diseases Hospital, China20
已完成
3 期
Phase III B in Acute Lymphoblastic LeukemiaAcute Lymphoblastic LeukemiaNCT03123939Novartis Pharmaceuticals69