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Cancer Immunotherapeutic (PCI) Strategy in Triple Negative Breast Cancer Patients | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

Cancer Immunotherapeutic (PCI) Strategy in Triple Negative Breast Cancer Patients

Phase 1 Clinical Trial of a Personalized Cancer Immunotherapeutic (PCI) Strategy +/- AB248 (CD8-selective IL-2 Mutein Fusion Protein) in Patients With a New Diagnosis of Triple Negative Breast Cancer Undergoing Neoadjuvant Chemoimmunotherapy

NCT07300475•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Newly diagnosed, previously untreated, locally advanced non-metastatic triple negative breast cancer (as defined by the most recent ASCO/CAP guidelines). Permissible staging per AJCC is as follows:
•* T1c, N1-N2
•* T2, N0-N2
•* T3, N0-N2
•At least 18 years of age.
•Adequate tissue available for nucleic acid isolation/PCI design.
•Adequate cardiac function per treating physician and a candidate for the KEYNOTE 522 regimen (or receiving the KEYNOTE 522 regimen for no more than one month).
•Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
•ECOG performance status ≤ 1 within 10 days of initiation of PCI
•Adequate bone marrow and organ function as defined below:
+8 more criteria

Exclusion Criteria

•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.
•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in the study.
•Received a live vaccine within 30 days of the first dose of pembrolizumab.
•Active autoimmune disease that has required systemic treatment in the past 2 years.
•Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.
•History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
•Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
+8 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

March 31, 2026

Primary Completion Date

January 8, 2030

Completion Date

December 9, 2034

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

Triple Negative Breast Cancer

Interventions

Paclitaxel

DRUG

Carboplatin

DRUG

Pembrolizumab

DRUG

Doxorubicin

DRUG

Cyclophosphamide

DRUG

Personalized cancer immunotherapeutic (PCI)

BIOLOGICAL

AB248 (CD8-selective IL-2 mutein fusion protein)

DRUG

pVAC tools neoantigen prediction algorithm

OTHER

poly-ICLC

DRUG

Contacts

William Gillanders, MD

CONTACT

314-747-0072 gillandersw@wustl.edu

Katherine Clifton, M.D.

CONTACT

314-273-3712 k.clifton@wustl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cancer Immunotherapeutic (PCI) Strategy in Triple Negative Breast Cancer Patients

Inclusion Criteria

Exclusion Criteria

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