临床试验/NCT06047977

NCT06047977招募中1 期

Tumor Infiltrating Lymphocytes in Pediatric Malignant Solid Tumors: A Prospective Biobanking Study and Phase I Clinical Trial

H. Lee Moffitt Cancer Center and Research Institute1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2025年6月2日最近更新: 2025年7月16日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: H. Lee Moffitt Cancer Center and Research Institute
入组人数: 30
试验地点: 1
主要终点: Safety of TIL therapy in Pediatric Solid Tumors

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Part One of this study will determine the feasibility of creating Tumor-Infiltrating Lymphocyte (TIL) product prospectively from high-risk pediatric solid tumors.

Part Two of this study will determine the safety of TIL therapy with lymphodepleting chemotherapy and post-TIL Interleukin-2 in high-risk pediatric solid tumors

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: 1 Year 至 21 Years（Child, 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

TIL Therapy

Experimental

TIL therapy with lymphodepleting chemotherapy and Interleukin 2

干预措施: Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2 (Biological)

结局指标

主要结局

Safety of TIL therapy in Pediatric Solid Tumors

时间窗: 3 years

The regimen will be declared safe if \<33% of patients (0 or 1 out of maximum 6 patients on the safety phase) experience a dose-limiting toxicity (DLT).

次要结局

Feasibility of Generating TIL Product from Pediatric Solid Tumors(3 years)
Disease Response to TIL Therapy(3 years)
Toxicity of TIL Therapy in Pediatric Solid Tumors(3 years)

研究者

发起方

H. Lee Moffitt Cancer Center and Research Institute

申办方类型

Other

责任方

Sponsor

研究点 (1)

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