Phase I Study of Allogeneic Transforming Growth Factor-beta Receptor Type 2 Knockout CD70 CAR NK Cells in Treatment Refractory Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
Testing an investigational cancer therapy called TGFBR-2 KO CD70 CAR NK cell therapy.
详细描述
Primary Objective • To determine the safety, tolerability, maximum tolerated dose (MTD), and optimal celldose (OCD) of chimeric antigen receptor TGFBR-2 KO CD70 CAR NK cells in participants with advanced ccRCC.
Secondary Objectives
• To determine the antitumor activity of TGFBR-2 KO CD70 CAR NK cells. Although the clinical benefit of TGFBR-2 KO CD70 CAR NK cells has not yet been established in ccRCC, the intent of offering this treatment is to provide a possible therapeutic benefit and thus, the participants will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.
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 —（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
Dose-expansion phase
干预措施: Dexamethasone (Drug)
Dose-expansion phase
干预措施: Fludarabine (Drug)
Dose-expansion phase
干预措施: Cyclophosphamate (Drug)
Dose-expansion phase
干预措施: TGFBR-2 KO CD70 CAR NK (Drug)
Dose-optimization phase
干预措施: TGFBR-2 KO CD70 CAR NK (Drug)
Dose-expansion phase
干预措施: Lymphodepleting chemotherapy (Drug)
Dose-optimization phase
干预措施: Lymphodepleting chemotherapy (Drug)
Dose-optimization phase
干预措施: Dexamethasone (Drug)
Dose-optimization phase
干预措施: Fludarabine (Drug)
Dose-optimization phase
干预措施: Cyclophosphamate (Drug)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTACAE) Version (v) 5.0
次要结局
未报告次要终点