CCL21-Gene Modified Dendritic Cell Vaccine and Pembrolizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer (NCT03546361)
A Phase I Trial of Intratumoral Administration of CCL21-Gene Modified Dendritic Cell (Ad-CCL21-DC) Combined With Intravenous Pembrolizumab for Advanced NSCLC
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial studies the side effects and best dose of autologous dendritic cell-adenovirus CCL21 vaccine (CCL21-gene modified dendritic cell vaccine) combined with intravenous pembrolizumab, and to see how well they work in treating patients with stage IV non-small cell lung cancer. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving CCL21-gene modified dendritic cell vaccine with pembrolizumab may work better in treating patients with stage IV non-small cell lung cancer.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (27 items) and avoid the listed exclusions (14 items).
Location: UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Comorbid disease or a medical or psychiatric condition that would impair the ability of the patient to receive or comply with the study protocol.
- Any use of systemic corticosteroids within 10 days of treatment initiation.
- Respiratory failure (defined as oxygen saturation \[SaO2\] \< 90% on room air; partial pressure of carbon dioxide \[PCO2\] \> 45 mmHg; or forced expiratory volume in one second \[FEV1\] \<1.0 liter).
- Acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed at least 7 days prior to study treatment.
- Human immunodeficiency virus (HIV) infected patients (defined as HIV-1/HIV-2 antibody positive).
- Patients with active hepatitis B or C. Active hepatitis B is defined as a known positive hepatitis B virus surface antigen (HBsAg) result. Active hepatitis C is defined by a known positive hepatitis (hep) C antibody (Ab) result and known quantitative hepatitis C virus (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay.
- Hypersensitivity to any reagents used in the study.
- Pregnancy or inadequate contraception.
- Lactating females.
- Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. In patients with brain metastases that have been treated with radiation therapy, treatment must end at least 14 days prior to starting study treatment. History of leptomeningeal disease is exclusionary regardless of prior therapy.
- Subjects with organ allografts.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.