The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting. — PGV-Prostate  

Prostate Cancer Clinical Trial

Official title: Phase I, Open-label, Single-center Proof of Concept Study Designed to Test the Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in Combination With CDX-301 in Subjects With a History of Prostate Cancer, in the Adjuvant Setting

Status Recruiting

Clinical Trial Summary

This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting.

Clinical Trial Description

This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting. This study will also assess the capacity of PGV001-based a multi-peptide therapeutic vaccines to produce a robust tumor antigen-specific T lymphocytic response in the peripheral circulation when combined with CDX-301, and it will expand the collective body of knowledge regarding the identification, selection and use of mutation-derived tumor antigens for personalized immunotherapy in prostate cancer patients. The purpose of the proposed trial will be to assess the following hypothesis: Mutation-derived tumor antigens (MTA) may arise as a result of somatic non-synonymous variations-including nucleotide substitutions, as well as small insertions and deletions-which occur during tumorigenesis. Somatic mutations may be characterized through the use of high-throughput sequencing technologies, and the resulting sequence data used to identify TSA. Sequence data can inform the design of patient-specific immune-based therapies, which may be capable of inducing quantitative changes in the concentration of circulating antigen-specific T lymphocytes directed against TSA, which may in-turn lead to immune-mediated elimination of residual malignant cells. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT05010200
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Sujit S Nair, Ph.D.
• Phone: 212-241-7005
• Email: Sujit.Nair@mountsinai.org
• Status: Recruiting
• Phase: Phase 1
• Start date: January 5, 2022
• Completion date: January 2028