NCT03546361

CCL21-Gene Modified Dendritic Cell Vaccine and Pembrolizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer

Active, enrolled Phase 1 Last updated 14 January 2025

What this trial tests

Phase 1 trial testing Autologous Dendritic Cell-Adenovirus CCL21 Vaccine in Lung Non-Small Cell Carcinoma in 24 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 July 2019

Primary endpoint
11 January 2026

11 January 2027

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	8 July 2019
Primary completion	11 January 2026
Estimated completion	11 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Autologous Dendritic Cell-Adenovirus CCL21 Vaccine — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Lung Non-Small Cell Carcinoma — all drugs for Lung Non-Small Cell Carcinoma →
• Stage IV Lung Cancer AJCC v8 — all drugs for Stage IV Lung Cancer AJCC v8 →
• Stage IVA Lung Cancer AJCC v8 — all drugs for Stage IVA Lung Cancer AJCC v8 →
• Stage IVB Lung Cancer AJCC v8 — all drugs for Stage IVB Lung Cancer AJCC v8 →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Lung Non-Small Cell Carcinoma or Stage IV Lung Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lung cancer immunotherapy: progress, pitfalls, and promises.
   Lahiri A, Maji A, Potdar PD, Singh N, et al · · 2023 · cited 737× · PMID 36810079 · DOI 10.1186/s12943-023-01740-y
2. Targeting cytokine and chemokine signaling pathways for cancer therapy.
   Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
3. Type I interferon-mediated tumor immunity and its role in immunotherapy.
   Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
4. Research progress on dendritic cell vaccines in cancer immunotherapy.
   Yu J, Sun H, Cao W, Song Y, et al · · 2022 · cited 130× · PMID 35074008 · DOI 10.1186/s40164-022-00257-2
5. Trial watch: dendritic cell vaccination for cancer immunotherapy.
   Sprooten J, Ceusters J, Coosemans A, Agostinis P, et al · · 2019 · cited 107× · PMID 31646087 · DOI 10.1080/2162402x.2019.1638212
6. Mechanisms of resistance to targeted therapy and immunotherapy in non-small cell lung cancer: promising strategies to overcoming challenges.
   Xiang Y, Liu X, Wang Y, Zheng D, et al · · 2024 · cited 85× · PMID 38655260 · DOI 10.3389/fimmu.2024.1366260
7. Role of chemokine systems in cancer and inflammatory diseases.
   Li H, Wu M, Zhao X. · · 2022 · cited 85× · PMID 35702353 · DOI 10.1002/mco2.147
8. Immune evasion in HPV<sup>-</sup> head and neck precancer-cancer transition is driven by an aneuploid switch involving chromosome 9p loss.
   William WN, Zhao X, Bianchi JJ, Lin HY, et al · · 2021 · cited 76× · PMID 33952700 · DOI 10.1073/pnas.2022655118