A Phase I Clinical Study of KXV01 TCR Lentinvivo Injection on Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose-limiting Toxicity
研究概览
简要总结
This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KXV01 TCR Lentinvivo for patients with advanced solid tumors.
详细描述
In recent years, the field has found that patient-specific anti-tumor treatment technologies have increasingly significant clinical application prospects and clinical value. Patient-specific anti-tumor in vivo TCR gene therapy is an advanced therapeutic strategy that can specifically recognize tumor neoantigens. This strategy is not restricted by patients' HLA typing nor by the type of indication.
This investigator-initiated clinical study aims to evaluate KXV01 TCR Lentinvivo, the third-generation self-inactivating lentiviral vector that carries patient-derived personalized tumor reactive TCR, in patients with advanced solid tumors. The study employs a BOIN design to assess safety, tolerability, and preliminary efficacy.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
KXV01 TCR Lentinvivo Injection
KXV01 TCR Lentinvivo Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries patient's personalized tumor-reactive TCR.
干预措施: KXV01 TCR Lentinvivo Injection (Drug)
结局指标
主要结局
Dose-limiting Toxicity
时间窗: 28 days after administraiton
DLT evaluation period: The DLT evaluation period is defined as within 28 days (inclusive) after the subjects' first administration of KXV01 injection during the dose escalation stage. All adverse events should be graded and evaluated in accordance with CTCAE v5.0. Among them, cytokine release syndrome (CRS) and immune effector cell-related neurotoxicity syndrome (ICANS) should be determined and graded in accordance with the standards of the American Society for Transplantation and Cell Therapy (ASTCT).
The Occurrence of Adverse Events
时间窗: From the signing of the informed consent form by the subjects until within 12 months after the administration of KXV01 injection, or when other anti-tumor treatment regimens have been initiated.
Any adverse medical event that occurs in patients or subjects of drug clinical research. It does not necessarily have a causal relationship with drug treatment or research procedures. Therefore, AE can be any adverse signs (including abnormal laboratory indicators), symptoms or diseases (new or aggravated) that are not related to the purpose of medication and have a temporal correlation with the investigational drug, regardless of whether these situations have a causal relationship with the investigational drug.
次要结局
未报告次要终点
研究者
jiuwei cui
Chief Physician
The First Hospital of Jilin University