A Single-center, Single-arm Exploratory Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 115
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
A Single-center, Single-arm Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Stage IIIA Non-Small Cell Lung Cancer
详细描述
This study is a single-center, single-arm, open-label, single-dose administration dose-finding study, which aims to evaluate the safety and efficacy characteristics of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Stage IIIA Non-Small Cell Lung Cancer.
The study includes a screening period, a treatment period, and an observation and follow-up period.
The main objectives :
To evaluate the safety and efficacy of multiple injections of PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in the treatment of patients with Stage IIIA Non-Small Cell Lung Cancer.
Primary Endpoints： Safety Endpoints: Incidence and severity of investigator-assessed adverse events (AEs), and clinically significant abnormal laboratory findings.
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
- •Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the informed consent form;
- •At the time of screening, the age should be between 18 and 75 years old (inclusive), regardless of gender;
- •Patients with histologically confirmed stage IIIA NSCLC (T4N0M0, T3-4N1M0, T1a-2bN2M0) who underwent R0 resection and received postoperative adjuvant chemotherapy (Exclusion of EGFR sensitizing mutations and ALK fusion); and who received the first dose of PANK-003 cell injection combined with postoperative adjuvant chemotherapy within 8 weeks after radical surgery.;
- •At the time of enrollment, the expected survival time is more than 6 Months;
- •The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
- •At the time of screening, the laboratory tests should meet the following requirements:
- •White blood cell count ≥ 3.0×10⁹/L;
- •Neutrophil count ≥ 1.5×10⁹/L;
- •Lymphocyte count ≥ 0.5×10⁹/L;
- •Hemoglobin ≥ 90 g/L;
- •Platelets ≥ 75×10⁹/L;
- •Serum total bilirubin ≤ 2.0 × ULN (Upper Limit of Normal); for patients with a history/suspected Gilbert's syndrome, total bilirubin (TBIL) must be ≤ 3 × ULN.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN;
- •Creatinine < 1.5×ULN and endogenous creatinine clearance rate ≥ 50 mL/minute (Cockcroft-Gault method for calculating creatinine clearance rate: For men, creatinine clearance rate = [(140 - age) × body weight (kg)] / [0.818 × creatinine (μmol/L)]; For women, creatinine clearance rate = [(140 - age) × body weight (kg) × 0.85] / [0.818 × creatinine (μmol/L)]).
- •Female subjects of childbearing potential must have a negative serum pregnancy test at screening and be willing to use medically recognized highly effective contraception during the study and for at least 1 year after the last study treatment; male subjects with partners of childbearing potential must have undergone surgical sterilization or agree to use effective contraception during the study and for at least 1 year after the last study treatment;
- •Investigator-confirmed eligibility for study enrollment.
排除标准
- •NSCLC patients who have received neoadjuvant therapy;
- •Pregnant or lactating women;
- •History of other malignancies, except:
- •Cured non-melanoma skin cancer
- •Carcinoma in situ of the cervix
- •Localized prostate cancer
- •Superficial bladder cancer
- •Other malignancies with disease-free survival >5 years;
- •Positive virology serology meeting any of:
- •HBsAg(+) and/or HBeAg(+) with HBe-Ab(+) and/or HBc-Ab(+) and HBV-DNA > lower limit of quantification
- •HCV-Ab(+)
- •HIV-Ab(+);
- •Received investigational drugs or other cell-based immunotherapy within 28 days before screening;
- •Administration of live/attenuated vaccines within 4 weeks prior to NK cell infusion;
- •Medical conditions requiring systemic corticosteroid therapy or other immunosuppressive drug treatments during the study period as determined by the investigator;
- •Hypersensitivity to:
- •Any component of NK cell products (including serum albumin)
- •Common emergency medications or anesthetics;
- •Unstable cardiovascular diseases within 180 days pre-screening, including:
- •Unstable angina
- •Myocardial infarction
- •Heart failure (NYHA class ≥III)
- •Severe arrhythmia requiring medication
- •Cardiac angioplasty, coronary stenting, or CABG;
- •Any condition that may compromise protocol compliance or patient safety as determined by the investigator:
- •Poorly controlled diabetes
- •Uncontrolled infections
- •Central nervous system disorders
- •Bleeding/thrombotic diathesis
- •Poor compliance
- •Substance abuse.
研究组 & 干预措施
PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
干预措施: PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: 3 months
Incidence, severity and clinically significant abnormal laboratory findings of treatment related AEs.
Disease Free Surviva Percentage（DFS%）
时间窗: 1 year
Disease Free Survival (DFS): The time from the first infusion day of PANK - 003 cell injection in subjects to the recurrence of the tumor (including local recurrence, regional recurrence, or distant metastasis) or death due to any cause. Disease Free Surviva Percentage（DFS%）: It refers to the proportion of subjects who have not experienced tumor recurrence or death at a specific follow-up time point, typically expressed as a percentage. Its core lies in using survival analysis methods, combined with the follow-up data of subjects, to estimate the disease-free survival probabilities at different time points.
次要结局
- Disease Free Survival (DFS)(1 year)
- Overall Survival (OS)(1 year)
- Tumor Recurrence Rate (TRR)(1 year)