Overview

Intratumoral Administration of CCL21-gene Modified Dendritic Cell With Intravenous Pembrolizumab for Advanced NSCLC

Status:
Not yet recruiting

Trial end date:
2023-09-01

Target enrollment:

Participant gender:

Summary

This is a phase 1 trial of intratumoral administration of CCL21-gene modified dendritic cells combined with intravenous pembrolizumab for advanced non-small cell lung cancer. Up to 12 patients will participate in the dose escalation phase and during dose expansion, 12 patients will be evaluated. Before the first injection of dendritic cells, blood will be collected from the patient and leukapheresis will be performed. Dendritic cells obtained from this blood draw will be cultured and induced with Ad-CCL21 gene. Then, the patient's lung tumor will be injected with these modified dendritic cells. This injection will be followed by treatment with 200 mg intravenous pembrolizumab. Patients will receive an injection of Ad-CCL21 DC followed by treatment with pembrolizumab on Days 0, 21, and 42. After these three injections, patients will receive pembrolizumab 200 mg every three weeks for up to one year. From enrollment of the first patient to the last dose administered to the last subject, this study is anticipated to take approximately 5 years to complete.

Phase:

Phase 1

Details

Lead Sponsor:

Jonsson Comprehensive Cancer Center

Collaborators:

California Institute for Regenerative Medicine
Merck Sharp & Dohme Corp.
National Cancer Institute (NCI)

Treatments:

Pembrolizumab