NCT04142619终止1 期
Phase I, Open-label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCARTCS1A (Allogenic Engineered T-cells Expressing Anti-CS1 Chimeric Antigen Receptor) Administered in Patients With Relapsed/Refractory Multiple Myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 16
- 主要终点
- Safety of UCARTCS1A
研究概览
简要总结
This is a Phase I, FIH, open-label, dose escalation study evaluating Safety and Efficacy of UCART targeting CS1 in patients with Relapsed or Refractory Multiple Myeloma (MM). The purpose of this study is to evaluate the safety and clinical activity of UCARTCS1A and to determine the Maximum Tolerated Dose (MTD).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of active multiple myeloma (as defined by International Myeloma Working Group [IMWG] criteria) who have relapsed/refractory disease after and have received at least 3 prior lines of prior therapy.
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1;
- •No previous treatment with investigational gene targeting CS1 or chimeric antigen receptor therapy targeting CS1
- •Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within the screening period.
- •Other criteria may apply.
排除标准
- •Previous treatment with investigational gene therapy targeting CS1 or chimeric antigen receptor therapy targeting CS1;
- •Any cellular therapy (other than autologous or allogenic HSCT) within 60 days prior to enrollment;
- •Prior treatment with rituximab or other anti-CD20 therapy within 3 months
- •Any known active or uncontrolled infection
- •Autologous hematopoietic stem cell transplantation (HSCT) within 12 weeks prior to enrollment; any cellular therapy (other than autologous) within 60 days prior to enrollment; prior allogeneic HSCT.
- •Seropositive for Hepatitis C virus or positive for Hepatitis B surface antigen or core antibody.
- •Presence of active and clinically relevant central nervous system disorder, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.
结局指标
主要结局
Safety of UCARTCS1A
时间窗: 24 months.
Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study.
次要结局
- Duration of Response(24 months)
- Progression Free Survival(24 months)
- Response Assessment(24 months)
- Overall Survival(24 months)
研究者
研究点 (16)
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