Actively Recruiting
In Vitro Culture of Autologous Dendritic and Natural Killer Cells for Treatment of Patients With Non-small Cell Lung Cancer
Led by National Taiwan University Clinical Trial Center · Updated on 2025-10-02
10
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Clinical Trial Center
Lead Sponsor
N
National Taiwan University Hospital, Yun-Lin Branch
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new therapy using a patient's 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.
CONDITIONS
Brief Title
DC/NK Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stage IIIB or IV non-small cell lung cancer, or with recurrence or progression after multimodal treatments
- Have undergone at least two systemic therapies for advanced NSCLC including platinum-based chemotherapy, anti-PD-1 therapy, or other targeted therapies
- Have at least one measurable lesion not receiving radiotherapy during treatment
- Age 20 years or older
- Weight between 40 and 100 kg
- Normal blood counts within 4 weeks before blood collection: WBC 63000/mm8, lymphocytes 631000/mm8, hemoglobin 6310 g/dL, platelets 63100,000/mm8
- Normal liver and kidney function within 4 weeks before blood collection: creatinine 631.25x ULN, total bilirubin 631.5x ULN, SGOT (AST) 633x ULN, SGPT (ALT) 633x ULN
- ECOG performance status score 0-1
- Signed informed consent
- Women of childbearing age must agree to use effective contraception during the trial
You will not qualify if you...
- Positive tests for HCV, HBV, HIV, HTLV, syphilis, or tuberculosis
- ECOG performance status score 2-4
- Intolerance to albumin
- Life expectancy less than 12 weeks
- Participation in other clinical trials within 30 days prior
- Pregnancy or breastfeeding
- Immunodeficiency, severe heart or lung dysfunction, coagulation disorders, unresolved side effects from prior cancer therapy (not recovered to grade 1), prior transplant surgery, or deemed unsuitable by physician
- Unable to comply with follow-up or examinations
- Diagnosis of other cancers within past 2 years
- Brain metastases, leptomeningeal disease, or spinal cord compression present
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive autologous dendritic cells via axillary lymph node injection and natural killer cells via intravenous injection cultured in vitro to test safety and evaluate responses.
Multiple visits during 12 weeks for cell administration and safety monitoring
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital Yunlin Branch
Huwei, YUNLIN, Taiwan, 640
Actively Recruiting
Research Team
C
Chung-Yu Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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