NCT04747093Unknown1 期
Induced-T Cell Like NK Cellular Immunotherapy for Refractory B Cell Malignancies
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Relapsed and refractory B cell malignancies show unfavorable prognosis, especially for adult patients. Now, there is no standard management for these patients. Induced-T cell-like NK cells with chimeric antigen receptor (CAR-ITNK cells) is a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of CAR-ITNK cells infusions in patients with relapsed and refractory B cell malignancies.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with CD19 positive B-cell acute leukemia
- •Eastern Cooperative Oncology Group (ECOG) performance status <2
- •ALT/ AST <3 x normal
- •Bilirubin < 2.0 mg/dl
- •Creatinine < 2.5 mg/dl and less than 2.5x normal for age
- •LVEF< 45%
- •Accept white blood cell collection
- •Provide informed consent
排除标准
- •Previous treatment with investigational gene or cell therapy medicine products
- •Active hepatitis B , hepatitis C or HIV infection
- •Uncontrolled active infection
- •Presence of grade 2-4 acute or extensive chronic GVHD
- •Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
- •Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •Received non-diagnostic purposes major surgery within the past 4 weeks
- •Participated in any other clinical study within the past 4 weeks
- •Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
- •Pregnancy or breast-feeding women
- •Use of prohibited drugs:
- •Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to ITNK Cells infusion
- •Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to ITNK Cells infusion
- •GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to ITNK Cells infusion
- •Any situation that may increase the risk of the test or interfere with the test results
结局指标
主要结局
Adverse Events
时间窗: 12 months
次要结局
- DFS(1 year)
- OS(1 year)
- ORR(12 months)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University
研究点 (1)
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