NCT04674488Unknown早期 1 期
An Exploratory Clinical Study of TILs Treatment for Metastatic or Recurrent Cervical Cancer
Shanghai OriginCell Therapeutics Co., Ltd.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年12月9日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- dose limited toxicity, DLT
研究概览
简要总结
Prospective, single center, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic cervical 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years old;
- •ECOG (Eastern Cooperative Oncology Group) score is 0 or 1;
- •The case is diagnosed as cervical squamous cell carcinoma, adenosquamous carcinoma or cervical adenocarcinoma;
- •Patients who have metastasized or relapsed after initial treatment (surgery, chemotherapy or radiotherapy);
- •HPV (Human Papillomavirus)-DNA test shows HPV16 positive and/or HPV18 positive;
- •At least one measurable target lesion defined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumours);
- •The subject must have a lesion with a diameter of more than 10 mm and a volume of 1.5 cm3 or more (or a collection of resected lesions greater than or equal to 1.5 cm3). TILs can be separated after resection or malignant effusion;
- •Routine blood testing reaches the following indicators: neutrophils ≥ 1.5×10^9/L, PLT ≥60×10^9/L, Hb ≥9.0 g/dL, LY ≥0.4×10^9/L;
- •Liver and kidney function: ALT (Alanine Aminotransferase, alanine aminotransferase) or AST (Aspartate Aminotransferase, aspartate aminotransferase) index <2.5 times the normal value; creatinine clearance rate>50 ml/min; total bilirubin <1.5 times the normal value, Prothrombin time prolonged ≤ 4 s;
- •The treatment methods for malignant tumors, including radiotherapy, chemotherapy and biological agents (including granulocyte colony stimulating factor G-CSF, targeted drug therapy, etc.), must be stopped 28 days before the TILs are obtained;
- •Subjects with reproductive potential must be willing to implement the approved high-efficiency contraceptive method with informed consent and continue to implement it within 1 year after the completion of the clinical trial;
- •The subject is able to adhere to the research visit plan and other protocol requirements.
排除标准
- •Uncontrolled active systemic infection; patients with active viral hepatitis;
- •Confirmed HIV infection;
- •The electrocardiogram indicates myocardial ischemia; the left ventricular ejection fraction on ultrasonography of subjects over 40 years old is less than 45%;
- •Pulmonary function test (spirometry) proves that forced expiratory volume (FEV) 1<65% predicted or forced vital capacity (FVC)<65% predicted;
- •Patients with a history of COPD (Chronic Obstructive Pulmonary Disease), asthma, or other chronic lung diseases with significant symptoms;
- •The subject received systemic steroids equivalent to >15 mg/day of prednisone 2 weeks before sampling, except for inhaled steroids;
- •The patient has hereditary or acquired coagulopathy;
- •Medical history of organ or hematopoietic stem cell transplantation;
- •Patients who are pregnant or breastfeeding;
- •Those who suffer from serious neurological, mental or endocrine diseases, or those who have serious mental diseases that will hinder full informed consent;
- •The medical history of primary immunodeficiency, past immune system diseases includes autoimmune diseases that are active, or previously known or suspected to exist autoimmune diseases. Except for side effects of checkpoint inhibitors, vitiligo, psoriasis, type 1 diabetes, remission of childhood asthma, and remission of atopic side effects.
- •Suffered from other uncured malignant tumors in the past 5 years or at the same time, except skin basal cell carcinoma and thyroid cancer.
- •There are central nervous system metastases and central nervous system diseases with clinical significance;
- •Live vaccine was vaccinated 30 days before cell reinfusion;
- •Patients with a previous history of cell therapy within one year;
- •Patients with a history of acute drug allergy, especially those who are allergic to immunoglobulin drugs;
- •Any other conditions judged by the researcher will significantly increase the risk of participation.
结局指标
主要结局
dose limited toxicity, DLT
时间窗: 28 days
Safety and tolerability of TILs, as determined by the rate of Dose Limiting Toxicities (DLTs)
次要结局
- Progression-Free Survival, PFS(two years)
- Objective Response Rate, ORR(three months)
- Duration of Response, DOR(two years)
- overall survival, OS(two years)
- Disease Control Rate, DCR(two years)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
早期 1 期
TIL Cells for the Treatment of the Advanced Solid Tumors PatientsSolid TumorNCT05649618Fujian Cancer Hospital42
终止
2 期
Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical CarcinomaCervical CarcinomaNCT03108495Iovance Biotherapeutics, Inc.210
终止
1 期
TIL for Patients With Advanced Solid TumorAdvanced Solid TumorNCT06334783Hervor Therapeutics5
进行中（未招募）
1 期
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult ParticipantsSoft Tissue SarcomaPrimary Central Nervous System CarcinomaMelanomaRhabdomyosarcomaEwing SarcomaNCT06566092Iovance Biotherapeutics, Inc.40
进行中（未招募）
1 期
ACT-TIL and ANV419 for Advanced Melanoma.Advanced MelanomaNCT05869539University Hospital, Basel, Switzerland10