NCT05333588招募中早期 1 期
The Safety and Efficacy Study of Autologous Tumor-infiltrating Lymphocyte (TILs) Therapy Combined With Conventional Chemotherapy for Patients With Advanced Stage of Glioblastoma Multiforme.
Hebei Senlang Biotechnology Inc., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年2月15日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of adverse events related to TiLs infusion
研究概览
简要总结
The study is to evaluate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy for patients with maligant glioblastoma multiforme. Autologous TiLs should be given by intravenous infusion after 5 days of lymphodepletion treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 80 years old;
- •Has at least one measurable tumor foci;
- •ECOG score range : 0-2;
- •Expected survival time: ≥ 3 months;
- •All screening labs should be performed 7 days prior to registration.The laboratory results need to meet below criteria:
- •Absolute white blood cell counts (WBC) ≥ 3.0×10^9/L；
- •Platelet count (PLT) ≥ 100×10^9/L；
- •Hematological Absolute neutrophil count (ANC) ≥ 1.5×10^9/L；
- •Hemoglobin (HGB) ≥ 90g/L;
- •Albumin (absolute) ≥ 2.8g/dL;
- •Serum ALT/AST ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
- •Total bilirubin (TBIL) ≤ 1.5×ULN (for patients with liver metastasis ≤ 2×ULN);
- •Renal Serum creatinine OR measured or calculated a creatinine clearance (CR) ≤1.5×ULN OR≥ 50 mL/min for participant;
- •AST/ALT (SGOT) ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
- •International Normalized Ratio (INR) ≤ 1.5;
- •Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN;
- •Female participant of childbearing potential should have a negative result of human chorionic gonadotropin (HCG) test. The participants must take contraception during the entire clinical follow-up.
- •Be willing and able to provide written informed consent/assent for the trial.
排除标准
- •Has systemic active infection and requiring treatment;
- •Has severe physical or mental illness;
- •Has active rheumatic disease;
- •Has any kinds of organ transplantation;
- •Being pregnant or lactating;
- •Enrolled in other clinical trials within 4 weeks prior to registration;
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C;
- •Other conditions that the researcher considered to be excluded;
- •Has taken blow treatment before enrollment:
- •Received systemic immunosuppressive treatments, aside from corticosteroids within 14 days of treatment;
- •Plan to get inactivated vaccine 28 days prior/during, or 60 days post the treatment.
结局指标
主要结局
Number of adverse events related to TiLs infusion
时间窗: 1 month
The primary outcome measure of this clinical trial is accessed by the safety of the TILs product. The safety profile for TILs is characterized by its incidence of the adverse events.
次要结局
- Progressional free of survival (PFS)(Up to 24 months)
- Objective response rate (ORR)(24 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study of GC101 TIL in Advanced Solid Tumors (TR)Advanced Solid TumorsNCT04967833Shanghai Juncell Therapeutics20
Unknown
1 期
Study on TIL for the Treatment of r/r Gynecologic TumorsGynecologic CancerNCT04766320Shanghai 10th People's Hospital15
招募中
1 期
A Study of GC101 TIL in r/r Gastrointestinal Tumors (10hospital)Gastrointestinal TumorNCT04960072Shanghai Juncell Therapeutics50
招募中
1 期
Study of GC101 TIL in Brain Glioma (Soochow2)GliomaNCT04943913Shanghai Juncell Therapeutics50
招募中
早期 1 期
A Study of TIL in Advanced Solid Tumors (DFGD)Advanced Solid TumorTumor Infiltrating LymphocytesTreatment Side EffectsEffects of ImmunotherapyNCT06488950Shanghai Juncell Therapeutics30