An Open-Label, Multicenter, Phase Ib/II Clinical Trial of GR1803 Injection in Combination With an Anti-CD38 Monoclonal Antibody Evaluating Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy in Subjects With Relapsed/Refractory Multiple Myeloma Previously Treated With at Least One Line of Therapy Including Lenalidomide and a Proteasome Inhibitor
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Dose expansion: Overall Response Rate
研究概览
简要总结
The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 grade of 0, 1 or 2;
- •Diagnosis of multiple myeloma；have received at least one prior line of therapy including Lenalidomide and a proteasome inhibitor.
- •Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign informed consent.
排除标准
- •Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.
- •Active central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- •Prior treatment with any BCMA-targeted therapiy.
- •Active infecion.
- •Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
研究组 & 干预措施
GR1803 plus anti-CD38 monoclonal antibody
Participants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection.
干预措施: GR1803 injection (Drug)
GR1803 plus anti-CD38 monoclonal antibody
Participants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection.
干预措施: Anti-CD38 Monoclonal Antibody (Drug)
结局指标
主要结局
Dose expansion: Overall Response Rate
时间窗: Up to 2 Years
The percentage of participants who have a partial response or better according to the International Myeloma Working Group criteria
Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT)
时间窗: Up to 2 Years
The dose limiting toxicities are defined as any of the following events: drug related hematological or non-hematological toxicity of grade 3 or higher.
Dose escalation: Number of Participants With Adverse Events and Serious Adverse Events
时间窗: Up to 2 Years
Adverse event is any untoward medical occurrence in a clinical trial participants administered a pharmaceutical product, regardless of causal relationship to the study treatment. This includes any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the product. Serious adverse event is an adverse event that results in any of the following outcomes: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, other medically important events.
次要结局
- Number of Participants With Anti-Drug Antibodies to GR1803 Injection(Up to 2 Years)
- Duration of Response(Up to 2 Years)
- Progression-Free Survival(Up to 2 Years)
- Serum Concentration of GR1803 Injection(Up to 2 Years)