DC/NK Cell Therapy

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. 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

Inclusion Criteria:

1. 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.
2. At Least One Measurable Lesion:

   o The measurable lesion must not undergo radiotherapy during the cell therapy period.
3. Age:

   o ≥20 years.
4. Weight:

   o Between 40 and 100 kg.
5. 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.
6. 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.
7. Informed Consent:

   o Participants must sign the consent form.
8. ECOG Performance Status:

   o Score of 0-1.
9. For Women of Childbearing Age:

   * Must agree to use effective contraception during the trial.

Exclusion Criteria:

1. 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).
2. ECOG Performance Status:

   o Score of 2-4.
3. Albumin Intolerance:

   o Participants who cannot tolerate albumin.
4. Short Life Expectancy:

   o Life expectancy estimated by the physician to be less than 12 weeks.
5. Participation in Other Clinical Trials:

   o Within 30 days prior to entering this trial.
6. Pregnancy or Breastfeeding:

   o Positive pregnancy test or currently breastfeeding.
7. 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.
8. Noncompliance:

   o Unable to adhere to follow-up or examination procedures.
9. Concurrent Cancer:

   o Other cancers diagnosed within the past 2 years.
10. Specific Complications:

    * Brain metastases, leptomeningeal disease, or spinal cord compression.

Conditions3

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