A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed/Refractory Multiple Myeloma.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel asymmetric trivalent tri-specific humanized antibody, MBS314, administered by intravenous (IV) infusion in participants with relapsed or refractory multiple myeloma. This entry-to-human study is divided in 2 parts: a dose escalation part (Phase Ⅰa) and an expansion part (Phase Ⅰb/Ⅱ).
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
- •Able and willing to provide written informed consent and to comply with the study protocol;
- •≥18 years of age;
- •Documented diagnosis of multiple myeloma according to 2014 IMWG diagnostic criteria.
- •Phase Ⅰb/Ⅱ: At least one measurable disease: Serum monoclonal paraprotein (M-protein) ≥5 g/L or Urine M-protein ≥200 mg/24 hours or Serum immunoglobulin free-light chains (FLCs) ≥100 mg/L and abnormal kappa/lambda FLC ratio (<0.26 or >1.65)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Life expectancy ≥3 months.
- •Adequate hematologic, hepatic, and renal function.
排除标准
- •Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- •Participants with known active infection within 14 days prior to the first MBS
- •Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal hepatitis B virus DNA or hepatitis C virus RNA).
- •Previously received anti-myeloma treatment within the specified time frame prior to the first administration.
- •Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, or expected to receive live, attenuated vaccines during the study period.
- •Major surgery within 28 days prior to the first infusion of MBS314, or expected to undergo major surgery during the study treatment.
- •Participants with a history of autoimmune diseases.
- •Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314.
研究组 & 干预措施
MBS314
干预措施: MBS314 Injection (Drug)
结局指标
主要结局
Phase Ia:Incidence of Dose Limiting Toxicities (DLTs)
时间窗: From Baseline up to 4 weeks
DLTs:Incidence of Dose Limiting Toxicities
Phase Ia:Maximum Tolerated Dose (MTD) of MBS314
时间窗: Up to approximately 11 months
MTD:Maximum Tolerated Dose
Phase Ia:Percentage of Participants with Adverse Events (AEs) .
时间窗: From Baseline up to approximately 29 months
Percentage of Participants with AEs and serious adverse events Assessed by NCI CTCAE v5.0.
Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314
时间窗: Up to approximately 29 months
RP2D: Recommended Phase II Dose
Phase Ib/Ⅱ :Efficacy: Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
时间窗: Up to approximately 4 years
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) response criteria assessed by the IRC.
次要结局
- Efficacy: Stringent Complete Response (sCR) Rate(Up to approximately 4 year)
- Efficacy: Minimal Residual Disease (MRD) Negative Rate(Up to approximately 4 years)
- Efficacy: Complete Response (CR) or Better Rate(Up to approximately 4 year)
- Efficacy: Very Good Partial Response (VGPR) or Better Rate(Up to approximately 4 year)