This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer immunotherapeutic (PCI) strategy with or without CD8-selective IL-2 mutein fusion protein in patients with triple negative breast cancer undergoing neoadjuvant chemoimmunotherapy.
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Treatment-emergent adverse events (TEAEs)
Timeframe: Step 1 enrollment to 30 days after completion of PCI treatment (estimated time of 115 days)
Treatment-related adverse events (TRAEs)
Timeframe: Step 1 enrollment to 30 days after completion of PCI treatment (estimated time of 115 days)
Serious adverse events (SAEs)
Timeframe: Step 1 enrollment to 30 days after completion of PCI 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 PCI design and manufacture
Timeframe: Start of Step 0 Enrollment to PCI completion (estimated time of 24 weeks)
Feasibility as determined by rate of successful PCI delivery
Timeframe: Day 1