A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101/203 TIL) in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have one the tumor resection for TILs production and successfully produced；
- •Age: 18 years to 75years;
- •Histologically diagnosed as solid tumors;
- •Expected life-span more than 3 months;
- •ECOG score 0-1;
- •Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy;
- •At least 1 evaluable tumor lesion;
排除标准
- •with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
- •Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
- •Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is < 95%;
- •Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
- •Significant cardiovascular anomalies
研究组 & 干预措施
Arm B
GC203 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
干预措施: GC203 TIL(gene-edited TIL) or autologous TILs (Biological)
Arm A
GC101 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
干预措施: GC203 TIL(gene-edited TIL) or autologous TILs (Biological)
结局指标
主要结局
Adverse Events
时间窗: 6 months
To characterize the safety profile of TILs in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events.
次要结局
- Disease Control Rate (DCR）(Up to 36 months)
- Duration of Response (DOR)(Up to 36 months)
- Progression-Free Survival (PFS)(Up to 36 months)
- Objective Response Rate (ORR)(Up to 36 months)