KCT0005542已完成未知
An Open-label, Single-arm, Single-center, Investigator-initiated Pilot Study to Investigate the Efficacy, Safety of Immuncell-LC in Combination with Nivolumab (Opdivo®) in Subjects with Advanced or Recurrent Gastric Cancer
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 4
研究概览
简要总结
The target number of subjects for this study is 20, and according to the monitoring plan, an average of 2 or more subjects must be recruited per month to ensure smooth research progress. However, due to difficulties in recruiting suitable subjects for this study, subject registration was slow. Accordingly, early termination was decided at the discretion of the Investigator.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1) Adult males and females aged 19 years or above
- •2) Histologically and/or cytologically confirmed unresectable advanced/relapsed gastric adenocarcinoma or gastro-esophageal junction cancer subjects
- •3) A measurable lesion based on RECIST v1.1
- •4) The Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
- •5) Life expectancy of at least 12 weeks
- •6) Confirmed adequate hematological, hepatic, renal and coagulation functions
排除标准
- •1) Prior treatment with any cell therapy products including but not limited to Immuncell-LC or natural killer (NK) cell therapy products
- •2) Prior immuno-oncology agents such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, and anti-CTLA-4
- •3) Hypersensitivity to the active ingredient or excipients of Immuncell-LC or nivolumab
- •4) Unable to collect autologous blood for production of Immuncell-LC at the judgement of the investigator
- •5) History of anti-cancer treatment within 2 weeks prior to screening
- •6) An adverse event (AE) with prior treatments that is not resolved
- •7) History of immunosuppressive drugs within 2 weeks prior to screening
- •8) Administration of live vaccines, live attenuated vaccines, or inactivated vaccines within 4 weeks prior to screening
- •9) Serious medical history confirmed at screening
- •10) Concomitant diseases at screening that may affect the safety and efficacy assessments during the study at the judgement of the investigator
- •11) Pregnant or breast-feeding women, or women who intend to become pregnant
- •12) Received other IP or used an investigational device within 4 weeks prior to screening
- •Ineligible or unable to participate in the study at the judgement of the investigator
研究者
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