NCT04662788尚未招募早期 1 期
Clinical Trial for the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies
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1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
Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies
详细描述
This is a single arm, open-label, single-center study. This study is indicated for hematological malignancies. 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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
- •Relapsed or refractory 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 flowcytometry);
- •Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
- •Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- •No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
- •Estimated survival time ≥ 3 months;
- •ECOG performance status 0 to 2;
- •Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
排除标准
- •History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
- •Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
- •Pregnant (or lactating) women;
- •Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
- •Active infection of hepatitis B virus or hepatitis C virus;
- •Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
- •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 ofpatients or interfere with the results of study.
研究组 & 干预措施
Administration of NK cells/Combined Monoclonal Antibodies
Experimental
干预措施: NK cells/Combined Monoclonal Antibodies (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years after NK cells/Combined Monoclonal Antibodies infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after NK cells/Combined Monoclonal Antibodies infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
- Acute Myeloid Leukemia (AML), Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- AML, Overall survival (OS)(Up to 2 years after NK cells infusion)
- AML, Event-free survival (EFS)(Up to 2 years after NK cell/ Combined Monoclonal Antibodies infusion)
- 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)
- Activities of Daily Living (ADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
- Instrumental Activities of Daily Living (IADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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