Personalized dendritic cell and natural killer cell therapy for advanced NSCLC
In Vitro Culture of Autologous Dendritic and Natural Killer Cells for the Treatment of Patients With Non-small Cell Lung Cancer
This trial will test whether giving people with advanced non-small cell lung cancer infusions of their own lab-grown dendritic cells (into an axillary lymph node) and natural killer cells (by IV) is safe and helps the NK cells kill tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Huwei, YUNLIN) |
| Trial ID | NCT07202611 on ClinicalTrials.gov |
What this trial studies
This Phase 2, interventional trial uses patients' own immune cells grown in the lab: autologous dendritic cells are injected into an axillary lymph node and expanded natural killer (NK) cells are given intravenously. The primary goal is to measure safety and immediate reactions to these cell formulations. Secondary objectives include confirming the success rate of cell culture and measuring the NK cells' tumor-killing activity in laboratory and clinical assays. Eligible participants are adults with stage IIIB/IV or recurrent/progressive NSCLC who have received at least two prior systemic therapies; the trial is conducted at National Taiwan University Hospital Yunlin Branch.
Who should consider this trial
Good fit: Ideal candidates are adults (≥20 years) with stage IIIB/IV or recurrent/progressive non-small cell lung cancer who have had at least two systemic therapies (including platinum chemotherapy and anti‑PD‑1 or targeted agents), have at least one measurable lesion, and meet laboratory safety criteria (adequate blood counts and liver/kidney function).
Not a fit: Patients with early-stage disease, inadequate blood counts or organ function, active radiotherapy to the target lesion during the cell therapy period, or who cannot undergo blood collection for cell preparation are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could provide an additional, personalized immune-based option that helps patients' own immune cells attack lung tumors with acceptable safety.
How similar studies have performed: Early-phase NK cell therapy studies and small combination trials have shown promising signals of activity and safety but remain experimental and not yet proven to extend survival in large randomized studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Huwei, YUNLIN
- National Taiwan University Hospital Yunlin Branch — Huwei, Yunlin, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chung-Yu Chen
- Email: c8101147@ms16.hinet.net
- Phone: 886-5-5323911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.