Study of Autologous Dendritic and Natural Killer Cell Therapy for Treating Advanced Non-small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new therapy using a patients own dendritic cells DCs and natural killer NK cells cultured in the lab to treat advanced non-small cell lung cancer NSCLC. This Phase 2 study focuses on patients with stage IIIB or IV NSCLC, including those with recurrence or progression after other treatments. The goal is to understand how these immune cells behave when given via lymph node injection and intravenous infusion and to explore their ability to fight cancer cells. Participants receive autologous dendritic cells injected into the axillary lymph nodes and natural killer cells through intravenous infusion. These cell formulations are cultured in vitro to boost their anti-cancer properties. The study assesses the safety of these treatments by monitoring reactions after administration. The trial also measures the success of cell preparation, including cell viability and tumor-killing capacity, and evaluates tumor responses using standard criteria during the 12-week treatment period. During the study, participants undergo regular monitoring including blood tests to check blood counts and liver and kidney function before cell collection. Researchers track adverse events and measure tumor response to the therapy with specified timelines up to 12 weeks. Participants must meet specific health criteria and agree to follow-up visits. The primary focus is on safety, while secondary outcomes include the effectiveness of the cultured cells against the cancer. The entire participation timeline includes screening, treatment, and evaluation phases.

DC/NK Cell Therapy