Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Myeloid Leukemia
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of AE after CAR-T infusion
研究概览
简要总结
Researchers plan to enroll a total of 100 patients with relapsed, refractory acute myeloid leukemia (AML) to receive a single dose of autologous CAR T cells.The safety of CAR T therapy was evaluated by observing adverse events after cell therapy;The efficacy of CAR-T therapy was evaluated against the outcome of patients' own past standard treatment regimens or historical data.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the pharmacokinetics (PK) of CAR 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
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of myeloid leukemia was clear;Refractory treatment was defined as: (1) 2 patients who did not achieve partial remission after treatment with standard induced remission regimens.② The patients who relapsed within 6 months after the first remission were also called early recurrence.③ The failure relapsed 6 months after the initial response, but was retreated with the original induced response regimen.(4) multiple relapse.Relapse is defined as: patients who achieve complete remission after treatment, more than 5% of leukemia cells in the bone marrow, also known as intramedullary recurrence;Or the presence of leukaemia outside the bone marrow, also known as extramedullary relapse (usually in the central nervous system, testicular leukemia is the most common);
- •Diseased cells were confirmed to express CD123, CLL1 and other targets;
- •KPS > 60 points;
- •Expected survival of more than 3 months;
- •No gender limitation, age 2-75;
- •Patients clinically diagnosed as high-risk type, refractory type of recurrence or not eligible for standard treatment;
- •No serious mental disorders;
- •Sufficient heart, liver and renal function (a. Liver function: ALT/AST < 3 times upper limit of normal value (ULN) and bilirubin ≤34.2μmol/L;B. Renal function: creatinine < 220μmol/L;C. Lung function: indoor oxygen saturation ≥95%;D. Cardiac function: left ventricular ejection fraction (LVEF) ≥40%;);
- •No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that are in conflict with this program;
- •Can cooperate with trial management and follow-up;
- •Patients voluntarily participated in the study and signed the informed consent
排除标准
- •History of other malignant tumors;
- •Uncontrolled active infection;
- •Patients with underlying diseases requiring systemic use of glucocorticoids;
- •Acute or chronic GVHD;
- •T-cell inhibitor therapy;
- •Pregnant and lactating women;
- •Patients with active hepatitis B;
- •Other conditions considered by the investigator to be inappropriate for the study (HIV infection, intravenous drug addiction, etc.), or other conditions that may affect the analysis of the results of the clinical study.
研究组 & 干预措施
Single arm
CLL-1 targeting CAR-T treatment
干预措施: Anti-CLL1 CART cells (Drug)
结局指标
主要结局
Incidence of AE after CAR-T infusion
时间窗: up to 12 months after CAR-T infusion
Incidence of adverse events after CAR-T infusion Data. The records of adverse events (AE) should include: description of AE and all related symptoms, occurrence time, severity, duration, measures taken, final results and outcomes. According to NCI CTC AE 5.0 standard, AE was scored Grade. Safety evaluation indexes include but are not limited to the following contents 1. Any spontaneously reported and all directly observed adverse events; 2. Any abnormal changes in vital signs and physical examination; 3. The abnormal results of laboratory examination, physical examination and blood examination with clinical significance after treatment
次要结局
- Change of CAR Copies(Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion)
- ORR rate(1month, 2 months, 3months, 6months ,12months after CAR-T infusion)
- PFS(1month, 2 months, 3months, 6months ,12months after CAR-T infusion)
- OS(1month, 2 months, 3months, 6months ,12months after CAR-T infusion)
- Change of CAR-T cell counts(Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion)