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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.2 个研究点分布在 1 个国家目标入组 138 人2024年8月7日

适应症Multiple Myeloma

干预措施SHR-9539 for injection

概览

阶段: 1 期
干预措施: SHR-9539 for injection
疾病 / 适应症: Multiple Myeloma
发起方: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
入组人数: 138
试验地点: 2
主要终点: RP2D of SHR-9539 injection
状态: 招募中
最后更新: 16天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2024年8月7日

结束日期

2027年7月31日

最后更新

16天前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

责任方

Sponsor

入排标准

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.