MedTrace Logo

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

NCT05010200 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

PGV-001

personalized genomic peptide vaccine

BIOLOGICAL

Poly-ICLC

immune modulator

BIOLOGICAL

CDX-301

soluble recombinant human protein to work on stem cell

Sponsors & Collaborators

  • Ashutosh Kumar Tewari

    lead OTHER

Principal Investigators

  • Ashutosh Tewari, MD · Icahn School of Medicine at Mount Sinai

  • Sujit S Nair, Ph.D. · Icahn School of Medicine at Mount Sinai

  • Dara Lundon, MD MSc MBA PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-05
Primary Completion
2027-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05010200 on ClinicalTrials.gov