About this trial
Primary Outcomes The primary objective of this trial is to test the safety of formulations containing dendritic cells (DCs) and natural killer (NK) cells cultured in vitro. By evaluating the reactions following the administration of autologous dendritic cells via axillary lymph node injection and natural killer cells via intravenous injection, the study aims to determine the safety profile of these trial products for human use.
Secondary Outcomes
To verify the success rate of the cultured cell formulations and assess the cytotoxic capacity of natural killer cells in targeting and killing tumor cells. The evaluation of these secondary objectives involves analyzing specific subcategories, which can be divided into two major components:
1. Validation of Cultured Cell Preparation Success: Assessing the proliferation rate, recovery rate, survival rate, and tumor-killing capacity of the cultured autologous dendritic cells and natural killer cells. 2. Validation of Antitumor Effectiveness: Evaluating the antitumor efficacy of the trial products administered via axillary lymph node injection of autologous dendritic cells and intravenous infusion of autologous natural killer cells.
Eligibility criteria
Qualifiers
Have undergone at least two systemic therapies for advanced NSCLC, including platinum-based chemotherapy, anti-PD-1 therapy, and/or other targeted therapies.
Hemoglobin: ≥10 g/dL.
Platelets: ≥100,000/mm³.
Creatinine: ≤1.25× the upper limit of normal (ULN).
Disqualifiers
HBV (HBsAg-positive).
HIV (HIV antibody-positive).
HTLV (HTLV antibody-positive).
Syphilis (Treponema pallidum antibody-positive).
Trial design
Treatments tested in this trial
- In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancer
Treatment groups
Sponsors and collaborators
National Taiwan University Clinical Trial Center
Lead sponsor
National Taiwan University Hospital
Sponsor institution
National Taiwan University Hospital, Yun-Lin Branch
Collaborator