Status:
RECRUITING
DC/NK Cell Therapy
Lead Sponsor:
National Taiwan University Clinical Trial Center
Collaborating Sponsors:
National Taiwan University Hospital, Yun-Lin Branch
Conditions:
Lung Cancer (NSCLC)
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Research Background and Current Status of Medical Technology According to data from the Ministry of Health, cancer has consistently ranked as the leading cause of death in Taiwan. Although various tre...
Eligibility Criteria
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.
- Age:
- o ≥20 years.
- Weight:
- o Between 40 and 100 kg.
- Normal Blood Count (based on test results within 4 weeks before blood collection for cell preparation):
- o White blood cells (WBC): ≥3000/mm³.
- o Lymphocytes: ≥1000/mm³.
- Hemoglobin: ≥10 g/dL.
- Platelets: ≥100,000/mm³.
- Normal Liver and Kidney Function (based on test results within 4 weeks before blood collection for cell preparation):
- Creatinine: ≤1.25× the upper limit of normal (ULN).
- Total bilirubin: ≤1.5× ULN.
- SGOT (AST): ≤3× ULN.
- SGPT (ALT): ≤3× ULN.
- Informed Consent:
- o Participants must sign the consent form.
- ECOG Performance Status:
- o Score of 0-1.
- For Women of Childbearing Age:
- Must agree to use effective contraception during the trial.
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).
- Tuberculosis (TB culture-positive).
- ECOG Performance Status:
- o Score of 2-4.
- Albumin Intolerance:
- o Participants who cannot tolerate albumin.
- Short Life Expectancy:
- o Life expectancy estimated by the physician to be less than 12 weeks.
- Participation in Other Clinical Trials:
- o Within 30 days prior to entering this trial.
- Pregnancy or Breastfeeding:
- o Positive pregnancy test or currently breastfeeding.
- Other Medical Conditions:
- o Immunodeficiency, severe heart or lung dysfunction, coagulation disorders, unresolved side effects from prior cancer therapy (not recovered to CTCAE grade 1), prior transplant surgery, or deemed unsuitable by the physician.
- Noncompliance:
- o Unable to adhere to follow-up or examination procedures.
- Concurrent Cancer:
- o Other cancers diagnosed within the past 2 years.
- Specific Complications:
- Brain metastases, leptomeningeal disease, or spinal cord compression.
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07202611
Start Date
December 2 2022
End Date
December 31 2025
Last Update
October 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital Yunlin Branch
Huwei, YUNLIN, Taiwan, 640