RecruitingPhase 1NCT06324240

Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

Clinical Evaluation of a Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Triple Negative Breast Cancer (TNBC)


Sponsor

Emory University

Enrollment

18 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine combined with an immunotherapy drug (a checkpoint inhibitor) for women with triple-negative breast cancer — a type of breast cancer that does not have hormone receptors or HER2 protein and is harder to treat. The personalized vaccine is made from the patient's own tumor mutations to train the immune system to attack the cancer. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with triple-negative breast cancer - Your physical performance (ECOG score) is 0 or 1 - Your blood counts and organ function are within acceptable ranges (checked within 14 days before vaccination) **You may NOT be eligible if:** - Your blood counts are too low (low white cells, platelets, or hemoglobin) - Your kidney or liver function is too poor - You have an active autoimmune condition requiring systemic treatment - You have received prior immunotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIpilimumab

Given IV

BIOLOGICALPembrolizumab

Given IV

BIOLOGICALVaccine Therapy

Given TMV vaccine ID


Locations(4)

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT06324240


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