This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine (PCV) strategy with or without CD8-selective IL-2 mutein fusion protein in patients with triple negative breast cancer undergoing neoadjuvant chemoimmunotherapy.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Treatment-emergent adverse events (TEAEs)
Timeframe: Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
Treatment-related adverse events (TRAEs)
Timeframe: Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
Serious adverse events (SAEs)
Timeframe: Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
Feasibility as determined by number of enrolled patients with triple negative breast cancer
Timeframe: Completion of enrollment (1 day for patient)
Feasibility as determined by time required for PCV design and manufacture
Timeframe: Start of Step 0 Enrollment to PCV completion (estimated time of 24 weeks)
Feasibility as determined by rate of successful PCV delivery
Timeframe: Day 1