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

NCT07300475 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Paclitaxel

As part of the KEYNOTE 522 Regimen, given per standard of care.

DRUG

Carboplatin

As part of the KEYNOTE 522 Regimen, given per standard of care.

DRUG

Pembrolizumab

As a part of the KEYNOTE 522 Regimen, given per standard of care. Adjuvant pembrolizumab will be given per standard of care.

DRUG

Doxorubicin

As part of the KEYNOTE 522 Regimen, given per standard of care.

DRUG

Cyclophosphamide

As part of the KEYNOTE 522 Regimen, given per standard of care.

BIOLOGICAL

Personalized cancer vaccine (PCV)

PCV is given intra-muscular (IM). Each PCV will consists of up to 4 separate injections, with each syringe containing peptides from one of the up to four peptide pools combined with adjuvant poly-ICLC.

DRUG

AB248

AB248 is given intravenously (IV) over 30 minutes at the recommended dose.

OTHER

pVAC tools neoantigen prediction algorithm

The pVACtools suite of software tools will be used to identify and prioritize cancer neoantigens based on neoantigen identification algorithms.

DRUG

poly-ICLC

Poly-ICLC is mixed with the personalized cancer vaccine (PCV). The PCV is given intramuscularly (IM) at 1mg dose.

Sponsors & Collaborators

Principal Investigators

  • William Gillanders, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2030-05-31
Completion
2035-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT07300475 on ClinicalTrials.gov