NCT04766320Unknown1 期
A Clinical Safety and Efficacy Study on TIL for the Treatment of r/r Gynecologic Tumors
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年1月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of Serious Adverse Events (SAEs)
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 malignant refractory/relapsed gynecologic tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with fludarabine and cyclophosphamide.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years to 75 years;
- •Histologically diagnosed as primary/relapsed/metastasized malignant tumors;
- •Expected life-span more than 3 months;
- •Karnofsky≥60% or ECOG score 0-2;
- •Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
- •Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
- •At least 1 evaluable tumor lesion;
- •Absolute count of white blood cells≥2.5×10^9/L, absolute count of neutropils≥1.5×10^9/L, platelet count≥100×10^9, hemoglobin≥90 g/L;
- •Serum creatinine clearance 50mL/min or higher; creatinine≤1.5×ULN; ALT/AST less than three times that of normal group, ALT/AST of test subjects with liver metastasis less than five times that of normal group; bilirubin≤1.5×ULN;
- •Activated partial thromboplastin time (APTT) less than or equal to 1.5xULN; international normalized ratio (INR) less than or equal to 1.5xULN;
- •Enough venous accessibility, no absolute or relative contraindications to operation or biopsy;
- •Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion；
- •Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;
- •Be able to understand and sign the informed consent document;
- •Be able to stick to follow-up visit plan and other requirements in the agreement.
排除标准
- •Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones);
- •Autoimmune diseases requiring immunomodulatory treatment;
- •Serum creatinine >1.5×ULN; serum glutamic-oxalacetic transaminase (SGOT) greater than 5×ULN; bilirubin >1.5×ULN;
- •Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
- •Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
- •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;
- •Severe physical or mental diseases;
- •Blood culture positive or imaging proof;
- •Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
- •History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
- •Having received immunotherapy and developed irAE level greater than Level 3;
- •Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
- •Females in pregnancy or lactation;
- •Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.
研究组 & 干预措施
Tumor Infiltrating Lymphocytes (TIL)
Experimental
1x10^9-3x10^11 in vitro expanded autologous TILs will be infused i.v. to patients with relapsed/refractory malignant gynecological tumors after NMA lymphodepletion treatment with fludarabine and cyclophosphamide. PD-1 checkpoint inhibitor would be applied as combination treatment to those patients.
干预措施: Tumor Infiltrating Lymphocytes (TIL) (Biological)
结局指标
主要结局
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to 12 months
Safety assessments. Incidence of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs). The severity of all adverse events was graded based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
次要结局
- Objective Response Rate (ORR)(Up to 36 months)
- Disease Control Rate (DCR）(Up to 36 months)
- Duration of Response (DOR)(Up to 36 months)
- Progression-Free Survival (PFS)(Up to 36 months)
- Overall Survival (OS)(Up to 36 months)
- Complete Response(CR)(Up to 36 months)
- Partial Response (PR)(Up to 36 months)
- Stable Disease (SD)(Up to 36 months)
- Progressive Disease (PD)(Up to 36 months)
研究者
Zhongping Cheng
Director of Department of Gynecology and Obstetrics
Shanghai 10th People's Hospital
研究点 (1)
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