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Taking people in TaiwanPhase 2

Tests cell therapy made from patients' own immune cells for lung cancer

Tests safety of patients' own dendritic and natural killer cells in lung cancer.

Key facts

Who runs it
National Taiwan University Clinical Trial Center
Where
Huwei, TaiwanSee the site
Trial code
Registry title
DC/NK Cell Therapy
Status
Recruiting
Phase
Phase 2
People taking part
10 people, planned
Started
2 Dec 2022
Planned end
31 Dec 2025
Type of study
Interventional
Treatments tested
  • In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancer
Record updated
2 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced non-small cell lung cancer who have already had at least two systemic treatments. It tests the safety of cell therapy made from the person's own blood cells.

Age
20 years or older
Sex
All sexes can join
Disease stage
Stage IIIB or stage IV non-small cell lung cancer, or cancer that came back or grew after earlier treatments. At least one measurable tumour lesion.
Earlier treatment
At least two systemic treatments for advanced non-small cell lung cancer, including platinum-based chemotherapy, anti-PD-1 therapy and/or other targeted therapies. The measurable lesion must not get radiotherapy during the cell therapy.

Main reasons for not taking part

  • Positive test for HCV, HBV, HIV, HTLV, syphilis or tuberculosis
  • ECOG performance status of 2-4 (needs 0-1)
  • Life expectancy under 12 weeks
  • Brain metastases, leptomeningeal disease or spinal cord compression
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participation in Other Clinical Trials:; o Within 30 days prior to entering this trial
  • Concurrent Cancer:; o Other cancers diagnosed within the past 2 years
  • 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)
  • 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
  • Specific Complications:; Brain metastases, leptomeningeal disease, or spinal cord compression
  • Albumin Intolerance:; o Participants who cannot tolerate albumin
  • ECOG Performance Status:; o Score of 2-4
  • Short Life Expectancy:; o Life expectancy estimated by the physician to be less than 12 weeks
  • Pregnancy or Breastfeeding:; o Positive pregnancy test or currently breastfeeding
  • Noncompliance:; o Unable to adhere to follow-up or examination procedures

Where in Taiwan

  • National Taiwan University Hospital Yunlin BranchHuwei, TaiwanContact: Chung-Yu ChenTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • In vitro culture of autologous dendritic and natural killer cells for the treatment of patients withTreatment being tested

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
In Vitro Culture of Autologous Dendritic and Natural Killer Cells for the Treatment of Patients With Non-small Cell Lung Cancer
Plain-language title
Tests cell therapy made from patients' own immune cells for lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 October 2025