DC/NK Cell Therapy

NCT07202611 | Recruiting Phase 2

• 1 other identifier: 201904109MIFC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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. 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. 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.

Conditions

Lung Cancer (NSCLC)

Keywords

lung cancer; cell therapy; NK cell; Dendritic cell

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse Events Following Administration of Autologous Dendritic Cells (via Axillary Lymph Node Injection) and Natural Killer Cells (via Intravenous Injection) cultured in vitro

  The primary objective of this trial is to evaluate the safety profile of in vitro-cultured dendritic cells (DCs) and natural killer (NK) cells. Specifically, the study will assess adverse reactions, including incidence, type, and severity of treatment-emergent adverse events, following administration of autologous DCs via axillary lymph node injection and NK cells via intravenous injection.

  12 weeks

Secondary Outcomes (3)

• Number of Participants with Successful Cultured Cell Preparation (Defined by ≥80% Cell Viability and Absence of Contamination)

  12 weeks

• Validation of Antitumor Effectiveness (In Vitro)

  12 weeks

• Proportion of Participants with Tumor Response (Complete Response, Partial Response, or Stable Disease per RECIST v1.1)

  12 weeks

Study Arms (1)

In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with

EXPERIMENTAL

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

Interventions

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

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.

In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Clinical Trial Center: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Huwei, YUNLIN, 640, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Chung-Yu Chen

CONTACT

886-5-5323911; c8101147@ms16.hinet.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Patients who diagnosed as 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), and have undergone at least two systemic therapies for advanced NSCLC, including platinum-based chemotherapy, anti-PD-1 therapy, and/or other targeted therapies.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: October 2, 2025
• Study Start: December 2, 2022
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)