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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
  PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy

Первичные конечные точки

• Incidence and severity of adverse events (AEs) [Срок оценки: 3 months]
• Disease Free Surviva Percentage（DFS%） [Срок оценки: 1 year]

Вторичные конечные точки (3)

• Disease Free Survival (DFS) [Срок оценки: 1 year]
• Overall Survival (OS) [Срок оценки: 1 year]
• Tumor Recurrence Rate (TRR) [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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(+)
• TP-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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07043907 · 2025-ETHICS COMMITTEE OPIN-038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗