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DC/NK Cell Therapy

ConditionLung Cancer (NSCLC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Clinical Trial Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have undergone at least two systemic therapies for advanced NSCLC, including platinum-based chemotherapy, anti-PD-1 therapy, and/or other targeted therapies.

Hemoglobin: ≥10 g/dL.

Platelets: ≥100,000/mm³.

Creatinine: ≤1.25× the upper limit of normal (ULN).

Disqualifiers

HBV (HBsAg-positive).

HIV (HIV antibody-positive).

HTLV (HTLV antibody-positive).

Syphilis (Treponema pallidum antibody-positive).

Trial design

Design model

Single group

Treatments tested in this trial

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

    Biological/Vaccine

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: In vitro culture of autologous dendritic and natural killer cells for the treatment of patients withExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

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

Validation will be based on cell viability, sterility testing, and phenotypic confirmation. A successful preparation is defined as viability ≥80%, absence of bacterial/mycoplasma contamination, and retention of lineage-specific surface markers as assessed by flow cytometry.

Time frame
12 weeks
2

Validation of Antitumor Effectiveness (In Vitro)

Percentage of Tumor Cells Exhibiting Reduced Viability After Treatment (MTT Assay)

Time frame
12 weeks
3

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

Number of Participants with Treatment-Emergent Objective Tumor Regression (≥30% Reduction in Target Lesions per RECIST v1.1)

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Clinical Trial Center

Lead sponsor

National Taiwan University Hospital

Sponsor institution

National Taiwan University Hospital, Yun-Lin Branch

Collaborator

Source ClinicalTrials.gov
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