NCT07330050招募中2 期
Phase II Clinical Trial Evaluating Whole Agonist-Stimulated T (WAST) Cells in Combination With Docetaxel as a Second-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC) Resistant to PD-1 Inhibitors
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This prospective Phase II study aims to evaluate the preliminary efficacy and safety of WAST cells combined with docetaxel as second-line therapy in patients with advanced NSCLC resistant to PD-1 inhibitors.
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
- All
- 接受健康志愿者
- 否
入选标准
- •At screening, patients must meet the following diagnostic and treatment criteria: 1) Histologically or cytologically confirmed NSCLC, 2) Advanced NSCLC as determined by imaging according to AJCC V8, 3) Disease progression after first-line treatment with a PD-1 inhibitor; Expected survival time greater than 3 months;
- •At screening, measurable target lesions on imaging with the longest diameter greater than 1.0 cm;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening;
- •Adequate bone marrow reserve at screening, defined as:
- •Absolute neutrophil count (ANC) >1.5×10⁹/L; Absolute lymphocyte count (ALC) ≥0.3×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Hemoglobin (HGB) ≥100g/L;
- •Adequate organ function at screening, meeting the following criteria:
- •Aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 ULN if due to tumor infiltration); Alanine aminotransferase (ALT) ≤2.5 times ULN (≤5 ULN if due to tumor infiltration); Total serum bilirubin ≤1.5 times ULN (≤3 ULN if due to tumor infiltration); Serum creatinine (Scr) ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min; Minimum lung reserve level, defined as ≤Grade 1 dyspnea and oxygen saturation >91% without supplemental oxygen; International Normalized Ratio (INR) ≤1.5 times ULN, and activated partial thromboplastin time (APTT) ≤1.5 times ULN;
- •Women of childbearing potential must have a negative urine pregnancy test, and any male or female patient capable of having children must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment.
排除标准
- •Patients with symptomatic central nervous system (CNS) metastases at screening (patients with asymptomatic CNS metastases, or those who have been treated locally and are stable without symptoms for 4 weeks, are eligible);
- •History of CNS disorders prior to screening, such as epilepsy, cerebrovascular ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes, psychiatric disorders, or any autoimmune diseases affecting the CNS;
- •Received immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening, and deemed unsuitable for enrollment by the investigator;
- •Discontinued systemic corticosteroid therapy less than 72 hours before cell infusion; however, physiological replacement doses of steroids (e.g., prednisone <10 mg/day or equivalent) are allowed;
- •Any history of adoptive cell therapy prior to screening;
- •History of organ/tissue transplantation prior to screening;
- •Known active systemic autoimmune diseases under treatment prior to screening;
- •At screening, meets any of the following criteria:
- •Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive; Hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive, with HBV-DNA copy numbers above the lower limit of quantification; Hepatitis C antibody (HCV-Ab) positive; Treponema pallidum antibody (TP-Ab) positive; HIV antibody test positive; EBV-DNA, CMV-DNA copy numbers above the lower limit of quantification;
- •Undergone major surgery within 4 weeks prior to screening and deemed unsuitable for enrollment by the investigator;
- •History of other malignancies within the past 2 years (except successfully treated non-melanoma skin cancer or in situ carcinoma);
- •At screening, meets any of the following cardiac conditions:
- •Left ventricular ejection fraction (LVEF) ≤50% (by ECHO); New York Heart Association (NYHA) class III or IV congestive heart failure; Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) or pulmonary hypertension despite standard treatment; Myocardial infarction or cardiac surgery within 12 months prior to cell infusion; Clinically significant valvular heart disease;
- •Tumor involvement of the atrium or ventricle at screening;
- •History of pulmonary interstitial fibrosis or severe chronic obstructive pulmonary disease (COPD);
- •Presence of clinical emergencies requiring urgent intervention due to tumor obstruction or compression (e.g., bowel obstruction or vascular compression) at screening;
- •Active bleeding at screening;
- •History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
- •Vaccinated with live vaccines within 6 weeks prior to screening;
- •Active infection requiring treatment at screening;
- •Participation in another interventional clinical study within 4 weeks prior to screening;
研究组 & 干预措施
WAST Cells Plus Docetaxel
Experimental
Patients will receive WAST cells in combination with docetaxel once every 3 weeks for 4 cycles. Following completion of the combination phase, patients will continue on docetaxel monotherapy until disease progression, unacceptable toxicity, or voluntary withdrawal from the study.
干预措施: Whole Agonist-Stimulated T (WAST) cells injection (Biological)
WAST Cells Plus Docetaxel
Experimental
Patients will receive WAST cells in combination with docetaxel once every 3 weeks for 4 cycles. Following completion of the combination phase, patients will continue on docetaxel monotherapy until disease progression, unacceptable toxicity, or voluntary withdrawal from the study.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Time Frame: Up to 24 months
ORR was defined as the percentage of patients with a confirmed complete (CR) or partial response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator.
次要结局
- Progression-free survival (PFS)(up to 24 months)
- Overall Survival (OS)(up to 3 years)
- Disease Control Rate (DCR)(up to 24 months)
- Duration of response (DOR)(up to 24 months)
- Number of Participants Who Experienced an Adverse Event (AE)(up to 24 months (Serious AEs: Up to 90 days after last dose of study treatment (Other AEs: Up to 30 days after last dose of study treatment))
研究者
研究点 (1)
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