NCT04919616尚未招募早期 1 期
An Exploratory Clinical Study of Autologous Tumor Infiltrating Lymphocytes (TILs) in the Treatment of Recurrent and Refractory Non-small Cell Lung Cancer (NSCLC)
Shanghai OriginCell Therapeutics Co., Ltd.0 个研究点目标入组 15 人开始时间: 2021年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- DLT（Dose limiting toxicity）
研究概览
简要总结
This study is an open, single-arm, dose-escalating phase I exploratory clinical trial to observe the safety, tolerability and preliminary efficacy of different doses of TILs in the treatment of relapsed and refractory NSCLC（Non-small cell lung cancer）.
The study includes 7 stages: ① screening period; ② tissue collection; ③ TILs cell production and preparation; ④ lymphocyte depletion pretreatment; ⑤ TILs cell infusion; ⑥ safety and efficacy evaluation; ⑦ follow-up.
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
- All
- 接受健康志愿者
- 否
入选标准
- •To participate in clinical trials and sign an informed consent form voluntarily;
- •18-70 years old;
- •ECOG (Eastern Cooperative Oncology Group) score is 0 or 1;
- •The patient's pre-survival period exceeds 3 months;
- •Patients with advanced stage IIIB or above (according to AJCC 8th Edition lung cancer staging criteria), and patients with stage IIIA or above who received targeted drugs or PD-1 treatment then failed;
- •Patients who have received systemic therapy of anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, biotherapy or targeted therapy), and whose progress has been confirmed after treatment;
- •At least one measurable target lesion defined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumours);
- •At least one tumor with a diameter of more than 10 mm and a volume of 1.5 cm3 can be resected or biopsied, and TILs can be separated after resection, or TILs can be separated from malignant effusion;
- •Blood routine test reached the following indicators: lymphocyte count ≥ 0.4 × 109 / L, neutrophils ≥ 1.0 × 109 / L, platelet ≥ 60 × 109 / L, hemoglobin ≥ 60g / L;
- •Liver and kidney function: ALT (alanine aminotransferase) or AST (aspartate aminotransferase) index < 2.5 times of normal value; Creatinine clearance rate > 50 ml / min; Total bilirubin < 1.5 times of normal value; Prothrombin time prolongation ≤ 4 s;
- •No heart disease or coronary heart disease, echocardiogram shows normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no serious arrhythmia;
- •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 14 days before obtaining tumor tissue;
- •Female patients with fertility must have a negative pregnancy test;
- •The fertile person or fertile partner must be willing to use an approved and effective contraceptive method during the treatment period and within 12 months after receiving all treatments related to the treatment regimen.
排除标准
- •Patients with a history of allergy to any component of the study drug;
- •Patients with symptomatic and/or untreated brain metastases;
- •Patients receiving systemic steroid therapy with prednisone or other steroid equivalent ≥ 10 mg / day. Patients with adrenocortical insufficiency receiving prednisone or other steroid equivalent ≤ 10 mg / day may be eligible;
- •Patients who received live or attenuated vaccines within 28 days before the start of treatment;
- •Patients who have received anti-cancer chemotherapy, radiotherapy or other medications within 2 weeks before screening;
- •Patients who participated in another interventional clinical study within 3 weeks before screening;
- •Patients with other primary malignant tumors in the past 3 years;
- •Patients who underwent organ transplantation or cell transplantation in the past 20 years;
- •Active infections requiring systemic treatment;
- •The subjects with positive HBsAg or HBcAb and more than 100 copies / L of HBV DNA in peripheral blood; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis antibody was positive in the first screening;
- •Active or previously recorded autoimmune or inflammatory diseases;
- •Patients with any form of primary or acquired immunodeficiency;
- •Patients with inherited or acquired coagulation disorders;
- •Patients with uncontrollable brain metastasis, spinal cord compression, cancerous meningitis within 8 weeks before the first medication, or brain or leptomeningeal disease detected by CT or MRI during screening;
- •Serious mental illness can hinder the full informed consent;
- •Breast feeding female patients;
- •Any investigator decides that it is not appropriate to participate in this trial.
研究组 & 干预措施
Single-arm
Experimental
干预措施: TILs（Tumor Infiltrating Lymphocytes） (Drug)
结局指标
主要结局
DLT（Dose limiting toxicity）
时间窗: 28 days
The severity of adverse events is graded according to NCT-CTCAE version 5.0, and the investigator will determine whether the subject has DLT. DLT is defined as: Grade 3 or above (CTCAE version 5.0) possible or confirmed related symptoms, laboratory toxicity and clinical events caused by the study treatment within 28 days after transfusion of TILs cells.
次要结局
- Objective Response Rate, ORR(3 Months)
- Progression-Free Survival, PFS(2 years)
- Duration of Response, DOR(2 years)
- overall survival, OS(2 years)
- Disease Control Rate, DCR(2 years)
研究者
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