Study of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma
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Allife Medical Science and Technology Co., Ltd.
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | November 2018 | ||
| 预计主要完成日期 | November 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Occurrence of treatment related adverse events as assessed by CTCAE v4.0[ Time Frame: 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 |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Study of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma | ||
| 正式标题 ICMJE | An Observational Clinical Study on the Safety and Efficacy of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma | ||
| 简要概况 | This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti CD22 CAR NK cells in patients with relapsed refractory B cell lymphoma |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Early Phase 1 | ||
| 研究设计 ICMJE | 分配: 干预模型: Sequential Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
9 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2021 | ||
| 预计主要完成日期 | November 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry 2. Previously accepted ≥ first-line regimen chemotherapy 3. Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation 4. Over 18 years old and under 70 years old 5. The expected survival period is more than 3 months. 6. ECOG≤2 7. 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; 8. Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L; 9. 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. 10. Measurable target lesion Exclusion Criteria: 1. Patients with extramedullary relapse 2. Burkitt's lymphoma/leukemia 3. Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment; 4. Liver and kidney function: Total bilirubin > 2 × ULN (Gilbert Syndrome > 3 × ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN Serum creatinine clearance >60 mL/min 5. Serological examination: Absolute neutrophil count (ANC) <0.75×109/L Platelet count (PLT) <50×109/L 6. Active hepatitis B (HBV-DNA > 1000 copies / mL), hepatitis C, or uncontrolled infection 7. GVHD ≥ 2 or anti-GVHD treatment 8. IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before reinfusion, such as donor lymphocyte reinfusion; 9. Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks 10. Active CNS disease (tumor cells in CSF, but < 5 WBCs/mL can be included); 11. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation 12. Creatinine > 1.5 times normal upper limit or ALT / AST > 3 times normal upper limit or bilirubin > 2 times normal upper limit 13. New York Heart Association (NYHA) graded above or above 14. Uncontrollable diabetes 15. Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining 16. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：70 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Allife Medical Science and Technology Co., Ltd. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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