NCT07444437招募中2 期
A Multicenter, Randomized, Controlled, Open-label, Phase IIa Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Adjuvant Treatment of Non-small Cell Lung Cancer With Negative Driver Gene Mutations
Suzhou BlueHorse Therapeutics Co., Ltd.4 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年2月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
After receiving neoadjuvant treatment with PD-1 antibody and undergoing radical resection, a total 36 to 45 NSCLC patients who met the inclusion criteria, will be randomly assigned in a 1:1:1 ratio to the experimental group 1, experimental group 2 and the control group in this Phase IIa clinical trial. The study will be followed up until 24 to 36 months after treatment.
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
- •At the date of signing Informed Consent Form (ICF), 18 ~75 years old, male or female;
- •Expected survival time >3 months;
- •ECOG performance status 0-1;
- •Pathologically diagnosed as resectable non-small cell lung cancer:
- •Received preoperative neoadjuvant therapy (including PD-1 antibody);
- •Screening criteria:
- •i. Driver gene mutations was negative; ii. No disease recurrence (including local recurrence) after surgery; iii. Expected to complete standard adjuvant therapy.
- •Patients have lesions that can be used for surgical resection or biopsy puncture;
- •Patients have sufficient hematology and organ functions;
- •Voluntarily sign a written informed consent form (ICF).
排除标准
- •A history of other malignant tumors within the past 5 years, excluding malignant tumors that can be expected to heal after treatment (including but not limited to well-treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery);
- •Adverse reactions caused by previous treatments have not been recovered to grade ≤1 (CTCAE V6.0) (excluding alopecia and neurotoxicity, and hypothyroidism, adrenal insufficiency and hypopituitarism that cannot be restored to grade 2 as determined by the investigators for a long time);
- •Any immune-related adverse reaction (irAE) with a severity level greater than grade 3 that has occurred during any previous immunotherapy and has been permanently discontinued;
- •Have received vaccination within two months prior to signing the ICF, or plan to receive vaccination during the study;
- •Have received TIL cell therapy, allogeneic T cell therapy or NK cell therapy within 6 months prior to signing the ICF;
- •Have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
- •Suffering from or suspected of having an active autoimmune disease;
- •Suffering from a large amount of pleural effusion or ascites with clinical symptoms or requiring symptomatic treatment;
- •Patients with current or previous irreversible interstitial lung disease;
- •Suffering from serious cardiovascular and cerebrovascular diseases;
- •Suffering from an active infection that requires systemic treatment;
- •Suffering from infectious diseases such as hepatitis B, hepatitis C, syphilis, AIDS;
- •Patients with esophageal or gastric varices requiring immediate intervention (such as ligation or sclerotherapy), or those with a higher risk of bleeding as recommended by the investigator or gastroenterologist or hepatologist, evidence of portal hypertension (including splenomegaly found in imaging examinations), or a history of variceal bleeding must undergo endoscopic assessment within 3 months before enrollment;
- •Uncontrolled metabolic disorders, such as diabetes, or other non-malignant organ or systemic diseases or secondary reactions to cancer, can lead to higher medical risks and/or uncertainties in survival assessment;
- •Those who are known to be allergic to any component of the investigational drug and the LM103 product formula;
- •Women who are pregnant or breastfeeding;
- •As determined by the investigators, there are other severe, acute or chronic medical diseases, mental disorders or laboratory abnormalities that may increase the risks related to participation in the study or may interfere with the interpretation of the study results.
研究组 & 干预措施
LM103 TILs +PD-1/PD-L1 monoclonal Group
Experimental
干预措施: LM103 TILs Injection (Biological)
LM103 TILs +PD-1/PD-L1 monoclonal Group
Experimental
干预措施: PD-1 / PD-L1 monoclonal antibody (Biological)
LM103 TILs Group
Experimental
干预措施: LM103 TILs Injection (Biological)
Control Group
Active Comparator
干预措施: PD-1 / PD-L1 monoclonal antibody (Biological)
结局指标
主要结局
Adverse Events (AEs)
时间窗: Maximum 24~36 months
AEs will be recorded and assessed according to CTCAE Version 6.0
Disease Free Survival
时间窗: Every 12 weeks from treatment to 24~36 months
Based on pathological diagnosis or imaging results
次要结局
- EORTC QLQ-C30(Every 12 weeks from treatment to 24~36 months)
研究者
研究点 (4)
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