NCT03690310Unknown早期 1 期
An Observational Clinical Study on the Safety and Efficacy of Anti-CD19 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma
Allife Medical Science and Technology Co., Ltd.0 个研究点目标入组 9 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 9
- 主要终点
- Occurrence of treatment related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 CAR NK cells in patients with relapsed refractory B cell lymphoma.
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
- •CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry
- •Previously accepted ≥ first-line regimen chemotherapy
- •Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation
- •Over 18 years old and under 70 years old
- •The expected survival period is more than 3 months.
- •Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL;
- •Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;
- •The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year.
- •Measurable target lesion
排除标准
- •Patients with extramedullary relapse
- •Burkitt's lymphoma/leukemia
- •Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment;
- •Liver and kidney function:
- •Total bilirubin > 2 x ULN (Gilbert Syndrome > 3 x ULN)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN
- •Serum creatinine clearance >60 mL/min
- •Serological examination:
- •Absolute neutrophil count (ANC) <0.75x109/L
- •Platelet count (PLT) <50x109/L
- •Active hepatitis B (HBV-DNA > 1000 copies / mL), hepatitis C, or uncontrolled infection
- •GVHD ≥ 2 or anti-GVHD treatment
- •IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;
- •Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks
- •Active CNS disease (tumor cells in CSF, but < 5 WBCs/mL can be included);
- •Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation
- •Creatinine > 1.5 times normal upper limit or ALT / AST > 3 times normal upper limit or bilirubin > 2 times normal upper limit
- •New York Heart Association (NYHA) graded above or above
- •Uncontrollable diabetes
- •Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining
- •Any situation that the investigator believes may increase the risk of the subject or interfere with the test results
研究组 & 干预措施
Anti-CD19 CAR NK Cells
Experimental
Total dose of 50-600 thousand /kg Anti-CD19 CAR NK cells will be administered at day0
干预措施: Anti-CD19 CAR NK Cells (Biological)
结局指标
主要结局
Occurrence of treatment related adverse events as assessed by CTCAE v4.0
时间窗: Day 3-Year 2 after injection
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
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