PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA NSCLC

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

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

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.

Efficacy Endpoint: 1-year DFS% assessed by the Independent Radiology Review Committee according to RECIST 1.1 criteria.

Inclusion Criteria:

1. Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the informed consent form;

2. At the time of screening, the age should be between 18 and 75 years old (inclusive), regardless of gender;

3. 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.;

4. At the time of enrollment, the expected survival time is more than 6 Months;

5. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;

6. 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)]).

7. 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;

8. Investigator-confirmed eligibility for study enrollment.

Exclusion Criteria:

1. NSCLC patients who have received neoadjuvant therapy;

2. Pregnant or lactating women;

3. 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;

4. 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(+)
   • TP-Ab(+)
   • HIV-Ab(+);

5. Received investigational drugs or other cell-based immunotherapy within 28 days before screening;

6. Administration of live/attenuated vaccines within 4 weeks prior to NK cell infusion;

7. Medical conditions requiring systemic corticosteroid therapy or other immunosuppressive drug treatments during the study period as determined by the investigator;

8. Hypersensitivity to:

   • Any component of NK cell products (including serum albumin)
   • Common emergency medications or anesthetics;

9. 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;

10. 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.