RecruitingPhase 2NCT07202611

DC/NK Cell Therapy

In Vitro Culture of Autologous Dendritic and Natural Killer Cells for the Treatment of Patients With Non-small Cell Lung Cancer

Sponsor

National Taiwan University Clinical Trial Center

Enrollment

10 participants

Start Date

Dec 2, 2022

Study Type

INTERVENTIONAL

Conditions

Lung Cancer (NSCLC)

Summary

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of immune cell therapy — using specially prepared dendritic cells (DC) and natural killer (NK) cells — in people with advanced or recurrent non-small cell lung cancer (NSCLC) who have already tried multiple other treatments. These immune cells are designed to help the body fight the cancer. **You may be eligible if...** - You have been diagnosed with stage IIIB or stage IV NSCLC, or your cancer has come back after prior treatments - You have already received at least two types of systemic treatment, including platinum-based chemotherapy and an anti-PD-1 immunotherapy - You are 20 or older and weigh between 40–100 kg - You have at least one measurable tumor that has not been recently irradiated - Your blood counts and organ function (liver and kidneys) are within acceptable ranges - Your overall health is rated as good (ECOG 0 or 1) **You may NOT be eligible if...** - You have active hepatitis C, HIV, or certain other infections - Your blood counts or organ function do not meet the required levels - You are pregnant - You have severe immune or coagulation disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALIn vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancer

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.