NCT03664661Unknown1 期
a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- occurrence of study related adverse events
研究概览
简要总结
Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma
详细描述
There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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 and ≤70 years old and the expected lifetime >3 months
- •Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry
- •No effective treatment option available
- •ECOG score 0-2
- •Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);
- •smoothly peripheral superficial veins
- •No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
- •No history of other malignancies
- •Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study
- •The patient himself agrees to participate in this clinical study and signed the "informed consent"
排除标准
- •Severe infectious 4 weeks before enrollment
- •Active hepatitis B or C viral hepatitis, HIV,
- •Severe autoimmune disease or immunodeficiency disease
- •Severe allergies
- •Severe mental disorder
- •Patients who used high-dose glucocorticoids within 1 week
- •Participation in other clinical studies in the past 3 months or having been treated with other gene products
研究组 & 干预措施
experimental group
Experimental
BCMA nanobody CAR-T cells
干预措施: BCMA nanobody CAR-T cells (Drug)
结局指标
主要结局
occurrence of study related adverse events
时间窗: 4 weeks
safety of CAR-T cells
次要结局
- Treatment response rate(3 months and 6 months)
- copy number of CAR-T cells(one year)
研究者
研究点 (1)
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