A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years to 70 years, expected survival > 3 months;
- •Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.
- •BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease.；
- •ECOG performance status of 0-2;
- •Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN;
- •No serious allergic constitution;
- •No other serous diseases that conflicts with the clinical program;
- •No other cancer history;
- •female participants of reproductive potential must have a negative serum pregnancy test;
- •Subjects must have signed written, informed consent.
排除标准
- •Pregnant or lactating women;
- •Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- •Active hepatitis B or hepatitis C infection;
- •Recent or current use of glucocorticoid or other immunosuppressor;
- •serious mental disorder;
- •With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- •Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
研究组 & 干预措施
anti-tumor response of BCMA CAR-T
Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days.
Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy.
干预措施: Fludarabine (Drug)
anti-tumor response of BCMA CAR-T
Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days.
Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy.
干预措施: Cyclophosphamide (Drug)
anti-tumor response of BCMA CAR-T
Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days.
Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy.
干预措施: BCMA CAR-T (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 1 year
number of participants with adverse events
次要结局
- Persistence of the BCMA CAR+ T cells(1 year)
- anti-tumor responses of BCMA CAR-T cells(1 year)