BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Adverse events that related to treatment
研究概览
简要总结
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
详细描述
There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent;
- •Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:
- •Failed to standard chemotherapy regimens;
- •Relapse after complete remission, high-risk and / or refractory patients ;
- •Relapse after hematopoietic stem cell transplantation;
- •Evidence for cell membrane BCMA expression；
- •All genders, ages: 18 to 75 years；
- •The expect time of survive is above 3 months;
- •No serious mental disorders ;
- •Left ventricular ejection fraction ≥50%
- •Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- •Sufficient renal function defined by creatinine clearance≤2 x ULN;
- •Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
- •With single or venous blood collection standards, and no other cell collection contraindications;
- •Ability and willingness to adhere to the study visit schedule and all protocol requirements.
排除标准
- •Previous history of other malignancy;
- •Presence of uncontrolled active infection;
- •Evidence of disorder that need the treatment by glucocorticoids;
- •Active or chronic GVHD；
- •The patients treatment by inhibitor of T cell；
- •Pregnant or breasting-feeding women;
- •Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
研究组 & 干预措施
BCMA CAR-T cells treat
Patients will be be treated with BCMA CAR-T cells
干预措施: BCMA CAR-T cells (Biological)
结局指标
主要结局
Adverse events that related to treatment
时间窗: 2 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
The response rate of BCMA CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy
时间窗: 2 years
The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG
次要结局
- Quantity of clonal plasma cells in bone marrow(1 years)
- Progress-free survival(PFS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma(2 years)
- Overall survival(OS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma(2 years)
- Duration of Response (DOR) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma(2 years)
- Quantity of BCMA CAR copies in bone marrow and peripheral blood(2 years)
- Levels of Cytokines in Serum(1 years)
- Rate of BCMA CAR-T cells in bone marrow and peripheral blood(2 years)