Personalized Cancer Vaccine (PCV) Strategy in Triple Negative Breast Cancer Patients

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

T1c, N1-N2

T2, N0-N2

T3, N0-N2

At least 18 years of age.

Disqualifiers

Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.

Received prior chemotherapy, targeted therapy, or radiation therapy within the past 12 months.

Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor.

Currently receiving any other investigational agents.

Trial design

Treatments tested in this trial

  • Paclitaxel
  • Carboplatin
  • Pembrolizumab
  • Doxorubicin
  • Cyclophosphamide
  • Personalized cancer vaccine (PCV)
  • AB248
  • pVAC tools neoantigen prediction algorithm
  • poly-ICLC

Treatment groups

30 Participants
are divided into 2 treatment groups