NCT07181239尚未招募3 期
A Phase III, Randomized, Open-Label, Multicenter Study Comparing CM336 Monotherapy vs. Investigators Selected Standard of Care in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received ≥2 Prior Lines of Therapy
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2025年9月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The purpose of this study is to compare the efficacy between CM336 and investigator's choice Standard of Care in relapsed or refractory multiple myeloma (RRMM) patients.
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
- •The subjects voluntarily sign the informed consent form (ICF) and agree to abide by the provisions of this protocol.
- •Age ≥ 18 years old, gender is not limited.
- •Eastern Cooperative Oncology Group performance status score (ECOG) 0-2 points.
- •Patients with relapsed or refractory multiple myeloma who have received at least two lines of anti-myeloma treatment previously, and must include at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-Cluster of Differentiation 38(CD38) monoclonal antibody.
- •The subject has evidence of disease progression or has not achieved remission after the last line of treatment, as determined by the investigator based on the International Myeloma Working Group (2016) criteria.
- •The subject has measurable disease at the screening period, meeting at least one of the following criteria:
- •Serum M protein ≥ 5 g/L;
- •Urinary M protein ≥ 200 mg/24 h;
- •Serum free light chain (sFLC) ≥ 100 mg/L and abnormal κ/ λ ratio.
排除标准
- •Previous receipt of any treatment targeting B-cell maturation antigen (BCMA).
- •Those who are intolerant to dexamethasone will be excluded.
- •Within 3 months prior to the first administration, they have received chimeric antigen receptor T cells (CAR-T) /chimeric antigen receptor Nature killer cell (CAR-NK) therapy.
- •Within 3 months prior to the first administration, they have received autologous stem cell transplantation; within 6 months prior to the first administration, they have received allogeneic stem cell transplantation (for subjects who have received allogeneic transplantation, they must have discontinued all immunosuppressants for ≥ 6 weeks and have no signs of graft-versus-host disease before being eligible for enrollment).
研究组 & 干预措施
Arm A: CM336
Experimental
干预措施: CM336 Injection (Drug)
Arm B: Standard of Care Regimens
Active Comparator
干预措施: Standard Of Care( SOC) (Drug)
结局指标
主要结局
PFS
时间窗: Up to 4 years
The progression-free survival (PFS) evaluated by Blinded Independent Central Review (BICR)
次要结局
未报告次要终点
研究者
研究点 (1)
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