A Multi-center, Open-label, Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a multi-center, open-label, Phase 1/2 study in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients with relapsed or refractory multiple myeloma.
This study consists of a dose escalation part (Phase 1) and a dose extension part (Phase 2 ).
The safety and tolerability of CM336 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.
The efficacy of CM336 will be evaluated in Phase 2 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-
- •Patients with relapsed or refractory MM who have failed or are intolerant to all therapies with known clinical benefit; patients must have received at least 2 prior anti-myeloma therapies which must contain at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 monoclonal antibody (if available).
排除标准
- •Patients who had received BCMA-targeted therapy.
- •Patients who had received CAR-T therapy.
- •Patients who had received anti-tumor therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of CM336.
研究组 & 干预措施
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 1 (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 2a (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 2b (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 3a (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 3b (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 4a (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 4b (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 5 (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 6a (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 6b (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 7 (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 8a (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 8b (Drug)
Phase 1, Dose escalation
There are 14 dose groups in dose escalation part ( Phase 1 study).
干预措施: CM336_group 9 (Drug)
Phase 2, Dose expansion
Based on the data of phase 1, the dose level recommended for the phase 2 study (RP2D) will be evaluated.
干预措施: CM336_RP2D (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLTs)
时间窗: 21 days after the first dose
Dose-limiting toxicities (DLTs)
Adverse events (AEs)
时间窗: Up to 4.5 years
Adverse events (AEs), including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Overall Response Rate (ORR)
时间窗: up to 4.5 years
Assessed according to International Myeloma Working Group (IMWG) response criteria.
次要结局
未报告次要终点