NCT07202611RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- 2 Dec 2022
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- National Taiwan University Clinical Trial Center
- Diseases
- Lung cancer
- NCT number
- NCT07202611
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From 2 Dec 2022 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Albumin Intolerance:
- o Participants who cannot tolerate albumin.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Yunlin Branch Coordinator of this site? Confirm its status | Huwei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.