NCT04008381Unknown1 期
Efficacy and Safety of Ex-vivo Expanded γδ T Lymphocytes in Patients With Refractory/Relapsed Acute Myeloid Leukaemia: a Single-center, Open-label, Single-arm Clinical Study.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Four-months remission rate
研究概览
简要总结
This study investigates the potential curative properties of ex-vivo expanded gamma delta T-cells obtained from a blood-related donor for patients with relapsed or refractory acute myeloid leukemia.
详细描述
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T-lymphocytes in patients with relapsed or refractory acute myeloid leukemia. PBMCs will be separated from peripheral blood of suitable donors. After making them potential cancer killer γδ T Cells, they will be infused to the patients as an immunotherapy treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow)
- •Relapsed or refractory AML. A. AML relapse after intensive chemotherapy; B. AML relapse after allogeneic HCT; C. AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine); D. No response to at least 4 cycles of low intensity therapy; E. AML refractory to 2 cycles of induction chemotherapy.
- •Presence of > 5% of blasts in bone marrow or peripheral blood smear
- •Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT)
- •Considered suitable for lymphodepleting chemotherapy
- •The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
- •Patient's main organs function well. A. Liver function: ALT/AST < 3 times the upper limit of normal (ULN); B. total bilirubin≤34.2μmol/L; C. Renal function: Creatinine < 220μmol/L; D. Pulmonary function: Indoor oxygen saturation≥95%; E. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%;
- •Life expectancy of at least 3 months
- •Patient ECOG score≤2, Estimated survival time≥3 months.
- •Ability to be off systemic prednisone and other immunosuppressive drugs for at least 3 days prior to γδ T cells product infusion. Maintenance replacement steroid is allowed.
- •The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to < 1 level at admission (except for low toxicity such as alopecia).
- •Patient able to understand and sign written informed consent
- •Age 18 years up to the age of 75 (≤ 75)
排除标准
- •Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- •Male or female with a conception plan in the past 1 years.
- •Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
- •Uncontrolled infectious disease within 4 weeks prior to enrollment.
- •Active hepatitis B/C virus.
- •HIV infected patients.
- •Suffering from a serious autoimmune disease or immunodeficiency disease.
- •The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
- •The patient participated in other clinical trials within 6 weeks prior to enrollment.
- •Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
- •Have a history of epilepsy or other central nervous system diseases.
- •Having drug abuse/addiction.
- •According to the researcher's judgment, the patient has other unsuitable grouping conditions.
结局指标
主要结局
Four-months remission rate
时间窗: 4 months
Number of patients reaching Complete Remission (CR) according to National Comprehensive Cancer Network (NCCN, Version 1.2015).
Number of participants with adverse events (AEs)
时间窗: 3 years
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).
次要结局
- Relapse-free survival(3 years)
- Overall survival(3 years)
- Event-free survival(3 years)
- lymphocyte subsets function assessment of bone marrow cells and peripheral blood cells(3 years)
- Quantity of gamma-delta T cells in bone marrow cells and peripheral blood cells(3 years)
研究者
MEI HENG
Principal Investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
研究点 (1)
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