NCT03940833Unknown1 期
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
Asclepius Technology Company Group (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Occurrence of treatment related adverse events as assessed by CTCAE v4.03
研究概览
简要总结
The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years to 80 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 - 1
- •Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，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-NK-92
Experimental
Patients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells.
干预措施: BCMA CAR-NK 92 cells (Biological)
结局指标
主要结局
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
时间窗: 1 year
Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
次要结局
未报告次要终点
研究者
研究点 (1)
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