NCT07202611
DC/NK Cell Therapy
Recruiting · Phase 2 · National Taiwan University Clinical Trial Center · registry updated 2025-10-02
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Eligibility of Participants:
- o Diagnosed histologically or cytologically with stage IIIB or stage IV non-small cell lung cancer (NSCLC) or patients with recurrence or progression following multimodal treatments (radiotherapy, surgical resection, or therapeutic chemoradiotherapy for locally advanced disease).
- Have undergone at least two systemic therapies for advanced NSCLC, including platinum-based chemotherapy, anti-PD-1 therapy, and/or other targeted therapies.
- At Least One Measurable Lesion:
- o The measurable lesion must not undergo radiotherapy during the cell therapy period.
- o ≥20 years.
Exclusion
- Positive Test Results for the Following Infections:
- o HCV (HCV antibody-positive).
- HBV (HBsAg-positive).
- HIV (HIV antibody-positive).
- HTLV (HTLV antibody-positive).
- Syphilis (Treponema pallidum antibody-positive).