肿瘤细胞治疗研究
英文原题：Allogeneic PB103 (NK Cells) Therapy in Non-small Cell Lung Cancer (NSCLC) Patients
⚠ 该试验的登记信息已有 20 个月未更新， 页面上显示的「招募中」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 I/II 期注册临床试验，评估供者来源 NK 细胞治疗非小细胞肺癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 24 例。试验地点：中国 · 台北（共 1 个中心，其中中国 1 个）。登记号：NCT04616209。
不限性别 · ≥ 20 Years 且 ≤ 70 Years
纳入标准： 受者： 1. 年龄20–70岁； 2. 有相关供者：HLA-A、-B和-DRB1位点6/6相合，或HLA-A、-B、-C和-DRB1位点≥4/8相合的半相合供者； 3. 已签署知情同意书； 4. 组织学或细胞学确诊IIIB–IV期非小细胞肺癌，不适合根治性多模式治疗；或既往确诊I–III期疾病后复发。分期按AJCC/IASLC第8版拟定标准判定； 5. 按RECIST v1.1标准有可测量或可评估疾病； 6. ECOG体能状态评分0、1或2分； 7. 预期生存期超过6个月； 8. 器官功能可接受，实验室指标如下：AST和ALT≤3.0×ULN（已知肝转移者AST和/或ALT≤5×ULN）；总胆红素≤1.5×ULN；ANC≥1500个/mm³；血小板≥75,000个/mm³；血红蛋白≥9.0 g/dL；估算GFR≥60 mL/min/1.73 m²或肌酐清除率≥60 mL/min。 供者： 1. 年龄20–65岁； 2. 相关供者HLA-A、-B和-DRB1位点6/6相合，或半相合供者HLA-A、-B、-C和-DRB1位点≥4/8相合； 3. 已签署知情同意书。 排除标准： 受者： 1. 有临床意义的间质性肺病或放射性肺炎史； 2. 脑转移或软脑膜疾病； 3. 治疗开始前4周内肺野接受过放疗；其他部位的姑息性放疗须在开始治疗前至少7天完成； 4. 研究药物开始前2周内接受过大手术（如胸腔、腹腔或盆腔手术），或尚未从手术不良反应中恢复。电视胸腔镜手术（VATS）和纵隔镜检查不视为大手术，术后≥1周可入组； 5. 接受抗癌治疗后毒性尚未按NCI CTCAE v5.0恢复至0–1级；白细胞及血红蛋白2级可接受； 6. 合并第二种临床活动性癌症；以根治为目的治疗且目前不活动的第二肿瘤允许入组； 7. 已知HIV血清阳性； 8. 正在接受其他研究药物；既往接受研究药物者须在治疗开始前完成至少1周或5个半衰期的洗脱期，以较长者为准； 9. 同时使用免疫抑制剂或长期使用皮质类固醇；局部、吸入或局部注射类固醇除外； 10. 有临床意义且未控制的心血管疾病，如筛查前6个月内不稳定型心绞痛或心肌梗死、左心室射血分数（LVEF）<50%、药物无法控制的心律失常，或未控制高血压（无论是否用药，收缩压≥160 mmHg和/或舒张压≥100 mmHg）。筛查前允许开始或调整降压药； 11. 存在需要静脉抗菌药物治疗的真菌、细菌、病毒或其他感染； 12. 妊娠期或哺乳期女性； 13. 研究者认为不适合参加研究的其他情况。 供者： 1. 妊娠期或哺乳期女性； 2. 患有晚期肿瘤； 3. 患有自身免疫性疾病； 4. HIV、梅毒血清学（RPR+TPHA）、CMV IgM、人T淋巴细胞病毒（HTLV）或乙/丙型肝炎病毒任一项阳性； 5. 研究者认为不适合参加研究的其他情况。
Inclusion Criteria: Recipient: 1. Recipients (Subjects) are between 20-70 years of age. 2. Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥ 4/8 match at HLA-A, -B, -C and -DRb1 3. Signed informed consent. 4. Subjects with histologically or cytologically confirmed non -small-cell lung cancer of stage IIIB-IV, not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is determined via the American Joint Committee on Cancer (AJCC)/IASLC 8th edition proposed staging criteria. 5. Subjects must have measurable or evaluable disease according to RECIST v1.1 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. Lifespan over 6 months. 8. Acceptable organ function, as evidenced by the following laboratory data: （a） Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN). (for patients with known hepatic metastases, AST and/or ALT ≤ 5× ULN) （b） Total serum bilirubin ≤ 1.5 × ULN （c） Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 （d） Platelet count ≥ 75,000 cells/mm3 （e） Hgb ≥ 9.0 g/dL （f） Estimated GFR ≥ 60 ml/min /1.73m2 or creatinine clearance ≥ 60 mL/min Donor 1. Donors are between 20-65 years of age. 2. Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥ 4/8 match at HLA-A, -B, -C and -DRb1 3. Signed informed consent. Exclusion Criteria: Recipient: 1. Patients with history of clinically significant interstitial lung disease or radiation pneumonitis. 2. Patients with brain metastases or leptomeningeal disease. 3. Patients who have had radiation to the lung fields within four weeks of starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting to treatment. 4. Patients who have had major surgery (e.g., intra-thoracic, intra-abdominal, or intra-pelvic) within two weeks prior to starting study drug or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the study ≥1 week after the procedure. 5. Patients who received anti-cancer treatment and did not recover from toxicities to grades 0-1 by NCI CTCAE (version 5.0) are not eligible but WBC and Hgb Grade 2 is acceptable. 6. Patients with a second, clinically active, cancer. Patients with second cancers that have been treated with curative intent and/or are currently inactive are allowed. 7. Known history of human immunodeficiency virus (HIV) seropositivity. 8. Participants who are receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least one week or five half-lives, whichever is longer, before starting treatment. 9. Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use, except those on topical or inhaled steroids, or steroids are given via local injection. 10. Patients with clinically significant, uncontrolled cardiovascular disease, such as unstable angina or myocardial infarction within 6 months prior to screening, abnormal left ventricular ejection fraction (LVEF \<50%), cardiac arrhythmia not controlled with medication, uncontrolled hypertension defined as an SBP ≥ 160mm Hg and/or DBP ≥ 100mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening. 11. Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management. 12. Pregnancy and lactating women. 13. Other situations the investigators think not eligible for participation in the research. Donor 1. Donors who are pregnant and lactating women. 2. Donor who has had advanced tumor diseases. 3. Donor who has had autoimmune diseases. 4. Donors are positive for one of human immunodeficiency virus (HIV), syphilis serology test (RPR+TPHA), CMV IgM, human T-lymphotropic virus (HTLV), and hepatitis B and C virus. 5. Other situations the investigators think not eligible for participation in the research.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：safety of PB103 · assessment of adverse events · one year
次要终点：efficacy of PB103
队列1：0.5×10⁹个细胞；队列2：1×10⁹个细胞；或队列3：1.5×10⁹个细胞。
研究目的：确定异基因PB103治疗IIIb/IV期或难治性非小细胞肺癌患者的安全性、耐受性和疗效。
Objectives: To determine the safety, tolerability, and efficacy of allogeneic PB103 in patients with IIIb/IV or refractory non-small-cell lung cancer
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