NCT06819293招募中1 期
A Phase I, Open Label, Single Center Study Evaluating the Safety and Efficacy of IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
Grit Biotechnology1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年12月6日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AEs
研究概览
简要总结
This is an open label, single center, dose escalation, and dose extension IIT study aimed at evaluating the safety, efficacy, and pharmacokinetics of IB-T101 in adult patients with advanced clear renal cell 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
- •Age ≥18 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •Expected survival time of ≥ 3 months;
排除标准
- •CNS dysfunction with clinical significance. For example, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune disease involving the CNS.
- •Any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). Known human immunodeficiency virus (HIV) positive subjects
- •Have experienced myocardial infarction or unstable angina within the 6 months prior to screening
- •Pleural effusion requiring drainage for symptom management within 28 days prior to screening
研究组 & 干预措施
IB-T101 injection treatment group
Experimental
干预措施: IB-T101 injection (Biological)
结局指标
主要结局
AEs
时间窗: 3 years
To characterize thesafty profile of autologous TIL injection IB-T101 in patients with advanced fclear renal cell carcinoma as measured by the incidence and severity of adverse events per CTCAE 5.0
Objective response rate
时间窗: 3 years
To evaluate efficacy parameters such Objective Response Rate(ORR) per RECIST v1.1, as assessed by the Investigater
次要结局
未报告次要终点
研究者
研究点 (1)
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