NCT06730659招募中1 期
A Single-Arm, Open-Label, Phase I Study of CHT101 for CD70-Positive Relapsed/Refractory Solid Tumors
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年4月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.
详细描述
4 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Ability to understand and sign a written informed consent documen；
- •At the date of signing ICF, 18 ~70 years old, male or female；
- •Histopathological confirmed advanced or metastatic solid tumors patients who have failed to standard treatment or intolerance with standard treatment；
- •Positive CD70 expression;
- •At least one measurable lesion at baseline per RECIST version 1.1；
- •The expected survival time is more than 12 weeks;
- •ECOG 0-1 points;
- •Adequate organ functions;
排除标准
- 未提供
研究组 & 干预措施
CHT101 infusion
Experimental
CHT 101 will be dosing by IV.
干预措施: CHT101 (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: 2 years
Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
次要结局
- pharmacokinetics (PK)(6 months)
- Objective response rate (ORR)(28 days)
- Disease control rate (DCR)(28 days)
- Progress-free survival(PFS)(2 years)
- Overall survival (OS )(3 years)
- Pharmacodynamics (PD)(6 months)
研究者
研究点 (1)
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