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• W4237173816 abstract "Effective immunotherapy options are lacking for patients with advanced non-small cell lung cancer (NSCLC) who progress on a programmed cell death-(ligand)1 [PD-(L)1] inhibitor and for those who are epidermal growth factor receptor (EGFR) mutation- or anaplastic lymphoma kinase (ALK) rearrangement-positive after progression on tyrosine kinase inhibitor (TKI) therapy. One potential approach to improve immune checkpoint efficacy in these patient populations is to promote tumor-specific T-cell activation via in situ vaccination with chemokine gene-modified functional antigen-presenting cells (APCs), which take advantage of the full repertoire of tumor antigens and convert the tumor into a lymph node-like environment. The chemokine C-C motif chemokine ligand 21(CCL21) promotes colocalization of naive T cells and dendritic cells (DCs) to promote tumor antigen presentation and facilitate T-cell activation. Our preclinical studies and phase I trial of intratumoral (IT) administration of CCL21 gene-modified DC (CCL21-DC) revealed augmentation of tumoral CD8+ T-cell infiltration and systemic antitumor immunity. However, increased PD-L1 expression was observed in some patient tumors, suggesting that tumor-mediated impairment of T-cell function may be forestalling a more robust antitumor response. Similarly, improved anti-PD-(L)1 efficacy may be possible with enhanced T-cell infiltration and augmented APC function following IT CCL21-DC. Therefore, we are conducting a phase I trial combining IT CCL21-DC with pembrolizumab in patients with advanced NSCLC with tumors accessible for IT injection, who are either (1) EGFR/ALK wild-type after progression on a PD-(L)1 inhibitor or (2) EGFR/ALK mutant after progression on TKI therapy. This is a phase I, single-institution, nonrandomized, dose-escalating, multicohort trial followed by dose expansion. A maximum of 24 patients (9-12 escalation + 12 expansion) with stage IV NSCLC will be evaluated. Three IT injections of autologous CCL21-DC (days 0, 21, 42) will be concurrently administered with pembrolizumab, followed by pembrolizumab once every 3 weeks for up to 1 year. Primary objective of dose escalation is safety and determination of maximum tolerated dose (MTD) of IT CCL21-DC when combined with pembrolizumab. Primary objective of dose expansion is objective response rate (ORR) of CCL21-DC at MTD combined with pembrolizumab. This trial, NCT03546361, is currently open for enrollment." @default.
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• W4237173816 date "2020-02-01" @default.
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• W4237173816 title "A33 Phase I Trial of in Situ Vaccination with Autologous CCL21-Modified Dendritic Cells (CCL21-DC) Combined with Pembrolizumab for Advanced NSCLC" @default.
• W4237173816 doi "https://doi.org/10.1016/j.jtho.2019.12.062" @default.
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