DC/NK Cell Therapy

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

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

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

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

National Taiwan University Clinical Trial Center

Lead sponsor

National Taiwan University Hospital

Sponsor institution

National Taiwan University Hospital, Yun-Lin Branch

Collaborator