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

Korábbi kezelés

• NSCLC patients who have received neoadjuvant therapy;
• 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;

Más betegség

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

Laborértékek

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

Életkor

• 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;

Egyéb

• Pregnant or lactating women;

• 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.