Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in Refractory/Recurrent Acute Myeloid Leukemia: a Single-arm, Non-blind Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion.
研究概览
简要总结
This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.
详细描述
The primary objective of the clinical trial was to evaluate the safety and efficacy of single dose infusion of anti-CLL1 /+CD33 CAR T cells in patients with refractory/recurrent acute myeloid leukemia. A total of about 5 patients with refractory/recurrent acute myeloid leukemia were enrolled in this study, and the target dose range was 1.00~2.50x10^6/kgCAR-positive T cells.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient or his/her legal guardian volunteers for the trial and signs an informed consent form;
- •Age range 1-18 years;
- •Acute myeloid leukemia (AML) with CLL1 and CD33 markers (including secondary patients) was diagnosed by pathology, histology and flow cytometry, or complete hematologic remission could not be achieved after 1 course of chemotherapy for hematologic relapse after drug withdrawal ;
- •The main organ functions of the patients were good: (1) liver function: ALT/AST < 3 times the upper limit of normal (ULN) and bilirubin ≤34.2 μmol/l; (2) renal function: creatinine < 220 μmol/l; (3) lung function: oxygen saturation ≥95% ; (4) cardiac function: left ventricular ejection fraction (LVEF)≥40% ;
- •The blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection;
- •ECOG score was 0-2.
排除标准
- •The patients had uncontrollable infectious diseases within 4 weeks before the enrollment;
- •Active hepatitis B/C virus;
- •HIV infection, treponema syphilis positive patients;
- •Pathological diagnosis of primary tumors other than acute myeloid leukemia;
- •Suffering from serious autoimmune diseases or immunodeficiency diseases;
- •The patient is allergic to antibodies or cytokines and other macromolecular biological drugs;
- •Pregnant or lactating women;
- •Patients who were considered ineligible for study for other reasons.
结局指标
主要结局
The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion.
时间窗: CAR T cell infusion before and 12 months after infusion
Track CAR-T cells expansion in patients after infusion by flow cytometry
Changes in cytokine level after CLL1/+CD33 CAR-T infusion
时间窗: CAR T cell infusion before and 12 months after infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion.
The change characteristics of chimeric antigen receptor(CAR)-T cell copy number in patients after infusion.
时间窗: CAR T cell infusion before and 12 months after infusion
Track CAR-T cells expansion in patients after infusion by Real-time Quantitative Polymerase Chain Reaction（qPCR）
次要结局
- MRD negative rate(Up to 12 months after CLL1/+CD33 CAR-T infusion)
- Overall survival(Up to 12 months after CLL1/+CD33 CAR-T infusion)
- Duration of Overall Response(Up to 12 months after CLL1/+CD33 CAR-T infusion)
- Event-free survival(Up to 12 months after CLL1/+CD33 CAR-T infusion)