NCT06484777招募中1 期
An Open-label, Multi-center Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of SHR-9539 Injection in Patients With Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- RP2D of SHR-9539 injection
研究概览
简要总结
This study is a multicenter, open-label, dose-escalation/dose-expansion clinical Phase I trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy profile of SHR-9539 Injection in patients with multiple myeloma.
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
- •Age ≥ 18 years on day of signing the Informed Consent Form;
- •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
- •Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria ；
- •Have a life expectancy of at least 3 months；
- •Male and female subjects with fertility must agree to use efficient contraceptive measures with their partners within 3 months after the last administration of the test drug from the time of signing the informed consent form, and have no fertility plan and avoid donating sperm / eggs. The pregnancy test during the screening period must be negative.
排除标准
- •Central nervous system (CNS) involvement of MM；
- •Diagnosis of amyloidosis, plasma cell leukemia, Wahl's macroglobulinemia, or POEMS syndrome;
- •Prior Grade 3 or higher CRS (Per ASTCT standards) related to any T cell redirection (eg, CD-3 redirection technology or CAR-T cell therapy).
- •Have other factors that may force the termination of the study, e.g., non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory abnormalities, associated family or social factors, which would affect the safety of the subjects or the collection of data and samples, as determined by the investigator.
研究组 & 干预措施
SHR-9539 for injection
Experimental
干预措施: SHR-9539 for injection (Drug)
结局指标
主要结局
RP2D of SHR-9539 injection
时间窗: Approximately 24 months
Determination of the recommended phase 2 dose (RP2D) of SHR-9539 injection in patient with multiple myeloma.
次要结局
- Incidence and severity of AE(Up to follow-up period, approximately 24 months)
- Cmax(Up to follow-up period, approximately 24 months)
- Overall Response Rate (ORR)(Up to follow-up period, approximately 24 months)
- Tmax(Up to follow-up period, approximately 24 months)
研究者
研究点 (1)
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