A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of participants with Dose Limited Toxicity
研究概览
简要总结
A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old, male or female;
- •Patients with advanced hepatocellular carcinoma who are confirmed by histopathology and/or cytology to be ineligible for surgery and local radical therapy and who have developed tumor progression or toxicity intolerance following at least one standardized systemic therapy (including molecularly targeted agents and immune checkpoint inhibitors) or interventional therapy
- •Liver cancer subjects with stage II or III of China Liver Cancer Staging (CNLC) as defined by Barcelona Clinic Liver Cancer (BCLC) B/C level or the Code of Practice for Primary Liver Cancer Diagnosis and Treatment (2022 edition);
- •Expected survival ≥3 months
- •Before the start of the research related procedures, after explaining the research content, voluntarily participate and be able to sign the informed consent; Agree to and have the ability to follow study visits, imaging tests, laboratory tests, and other research procedures in the study plan;
- •Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up.
排除标准
- •Have had other uncured malignancies within the past 5 years or at the same time, except for in situ cancers considered clinically curable, such as cervical carcinoma in situ and basal cell carcinoma of the skin
- •Central nervous system metastases and clinically significant central nervous system diseases
- •Pregnant or lactating women;
- •The investigator believes that the subjects have any circumstances that make them unfit to participate in this clinical study.
研究组 & 干预措施
Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells
干预措施: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :1.0×10^8(First dose group) (Biological)
Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells
干预措施: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :2.5×10^8(Second dose group) (Biological)
Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells
干预措施: Gene modified anti-IL1RAP Chimeric Antigen Receptor T Cells :5.0×10^8（Third dose group） (Biological)
结局指标
主要结局
Number of participants with Dose Limited Toxicity
时间窗: Within 28 days after the cell infusion
Number of participants with treatment associated adverse events (AE) and serious adverse events (SAE) according to CTCAE v5.0
时间窗: From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
Number of participants with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)
时间窗: From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
Number of participants with treatment associated changes in clinically significant laboratory safety test values
时间窗: From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
次要结局
- Curative effect evaluation(3 months after cell infusion)
- Disease control rate (DCR)(3 months, 6 months, 1 year, 2years after cell infusion)
- Changes of serum IL1RAP level(3 months, 6 months, 1 year, 2years after cell infusion)
- Changes of copy number and absolute value of CAR-T cells targeting IL1RAP in peripheral blood(3 months, 6 months, 1 year, 2years after cell infusion)
- Progression-free survival (PFS)(3 months, 6 months, 1 year, 2years after cell infusion)
- Median PFS(3 months, 6 months, 1 year, 2years after cell infusion)
- Time to remission (TTR)(3 months, 6 months, 1 year, 2years after cell infusion)
- Duration of response after administration (DOR)(3 months, 6 months, 1 year, 2years after cell infusion)
- Survival time: Median overall survival (mOS)(6 months, 1 year, 2years after cell infusion)
- OS rate(6 months, 1 year, 2years after cell infusion)
- PFS rate(3 months, 6 months, 1 year, 2years after cell infusion)