NCT04658004尚未招募早期 1 期
Clinical Trial for the Safety and Efficacy of NKG2D CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia
Zhejiang University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年1月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
A Study of NKG2D CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia.
详细描述
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory NKG2D ligand positive acute myeloid leukemia. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety,main consideration is dose-related safety.
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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of NKG2D ligand positive AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
- •Relapsed or refractory NKG2D ligand positive AML (meeting one of the following conditions):
- •CR not achieved after standardized chemotherapy;
- •CR achieved following the first induction, but CR duration is less than 12 months;
- •Ineffectively after first or multiple remedial treatments;
- •2 or more relapses;
- •The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flow cyto metry);
- •Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
- •Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- •No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
- •Estimated survival time ≥ 3 months;
- •ECOG performance status 0 to 2;
- •Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
排除标准
- •Subjects with any of the following exclusion criteria were not eligible for this trial:
- •History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- •Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- •Pregnant (or lactating) women;
- •Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- •Active infection of hepatitis B virus or hepatitis C virus;
- •Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
- •Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
- •Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
- •Other uncontrolled diseases that were not suitable for this trial;
- •Patients with HIV infection;
- •Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
研究组 & 干预措施
Administration of NKG2D CAR T-cells
Experimental
干预措施: NKG2D CAR T-cells (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years after NKG2D targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after NKG2D targeted CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
- Hospital Anxiety and Depression Scale (HADS) score(At Baseline, Month 1, 3, 6, 9 and 12)
- Quality of life(:At Baseline, Month 1, 3, 6, 9 and 12)
- Acute Myeloid Leukemia (AML), Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- AML, Event-free survival (EFS)(Up to 2 years after NKG2D CAR-T cells infusion)
- Instrumental Activities of Daily Living (IADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
- AML, Overall survival (OS)(Up to 2 years after NKG2D CAR-T cells infusion)
- Activities of Daily Living (ADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent GlioblastomaRecurrent GlioblastomaNCT04717999UWELL Biopharma20
终止
不适用
NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid LeukemiaSafety and EfficacyNCT05247957Hangzhou Cheetah Cell Therapeutics Co., Ltd9
Unknown
不适用
NKG2D CAR-NK & r/rAMLAMLNCT05734898Zhejiang University30
Unknown
1 期
NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid TumorsMedulloblastomaHepatocellular CarcinomaGlioblastomaColon CancerNCT05131763Fudan University3
撤回
1 期
NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid TumorsMedulloblastomaGlioblastomaColon CancerHepatocellular CarcinomaNCT04270461Jiujiang University Affiliated Hospital