Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients with 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 prime 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 prime 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 targeted prime CAR-T cells treat
Patients will be be treated with BCMA targeted prime CAR-T cells
干预措施: BCMA targeted prime 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 targeted prime CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA targeted prime CAR-T cells therapy
时间窗: 2 years
The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG
次要结局
- Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood(2 years)
- Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood(2 years)
- Progress-free survival(PFS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma(2 years)
- Levels of IL-6 in Serum(1years)
- Duration of Response (DOR) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma(2 years)
- Quantity of clonal plasma cells in bone marrow(1 years)
- Overall survival(OS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma(2 years)