NCT06544720招募中1 期
A Phase 1 Clinical Study of Autologous TCR-T Cells (SCG142) Therapy for Advanced HPV Associated Carcinomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
A multicenter, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of SCG142 TCR-T cells in Subjects with advanced HPV associated carcinomas.
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
- •Greater than or equal to 18 years of age
- •HPV associated carcinomas
- •Patients must have at least one measurable lesion defined by RECIST 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •Active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory.
- •Patients with active autoimmune diseases.
- •Patient has a known active Hepatitis B or Hepatitis C.
- •Other severe medical conditions that may limit subject's participation in this trial.
结局指标
主要结局
DLT
时间窗: 28 days
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
次要结局
- Efficacy: antitumor activity of SCG142(2 years)
研究者
研究点 (1)
Loading locations...
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