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

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.

Age

18–75

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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.

You may not be if

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.

What this study is about