NCT06245018尚未招募不适用
An Open, Dose Escalation and Extension Platform Trial to Evaluate the Safety, Pharmacological and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Natural Killer Cells (iNK) in Chinese Subjects With Solid Tumor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Adverse Event(AE) ，Serious Adverse Event(SAE)，Treatment Emergent Adverse Event（TEAE）and Treatment Related Adverse Event(TRAE)
研究概览
简要总结
This trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
详细描述
Solid tumor is a disease with high mortality rates. The aim of this trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old.
- •Subjects with recurrent or metastatic solid tumors that cannot accept radical locoregional therapy;
- •Systemic standard treatment failed or cannot tolerate serious toxicity or lack of standard treatment.
- •Have 1 or more focus can be accessed according to RECIST 1.1
- •Eastern Cooperative Oncology Group(ECOG):0-1
- •Expected survival period over 3 months
- •Have acceptable organ function and the results of laboratory examination meet the request below:
- •Hepatic Insufficiency (ALT) and Aspartate aminotransferase（AST）≤3xULN(upper limit of normal);Total Bilirubin≤3xULN；Creatinine≤3xULN；White blood cell count ≥3.0x10^9/L; Absolute Neutrophil Count≥1.0x10^9/L
- •Agree to contraception
- •Subjects who understand and voluntarily sign the Informed Consent Form（ICF)
排除标准
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms；
- •With active infection during screening
- •Have serious or uncontrolled basic diseases;
- •Have continuous adverse event caused by previous anti-tumor therapy that might affect the evaluation of drug safety；
- •Accept anti-tumor therapy within 28 days before first injection;
- •Accept general anesthesia surgery or radiation therapy within 28 days before first injection;
- •Accept live vaccine or attenuated live vaccine within 28 days before first injection;
- •Allergy to known drug components;
- •Serous cavity effusion requiring clinical intervention；
- •Pregnancy or prepare to pregnant during the treatment;
- •Other situations that not suitable to participate into this trial.
结局指标
主要结局
Adverse Event(AE) ，Serious Adverse Event(SAE)，Treatment Emergent Adverse Event（TEAE）and Treatment Related Adverse Event(TRAE)
时间窗: From the date of initial infusion to a year after initial infusion
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Dose-Limiting Toxicity(DLT)
时间窗: 4 weeks after initial infusion
Number of participants with Dose-limiting toxicity in 28 days after injection
次要结局
- Objective Response Rate（ORR）(During the whole study)
- Disease Control Rate（DCR）(From the date of initial infusion to a year after initial infusion)
- Duration Of Response（DOR）(First Injection to a year after Last Injection)
研究者
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