RecruitingEarly Phase 1NCT06435351

Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy

Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

16 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a personalized dendritic cell vaccine — a type of immune therapy made from your own immune cells and trained to recognize your specific tumor's mutations — in people with high-risk triple-negative breast cancer (TNBC) who still had significant cancer remaining after chemotherapy and surgery. **You may be eligible if...** - You are 18 or older - You have stage II or III triple-negative breast cancer (ER/PR ≤10%, HER2-negative) - You completed standard pre-surgery (neoadjuvant) chemotherapy and had surgery, but a significant amount of cancer remained (equivalent to residual cancer burden class II or III) - You have enough residual tumor tissue accessible to Moffitt Cancer Center for genetic sequencing to build the personalized vaccine - Your general health is good (ECOG 0–1) and your organ function meets study requirements **You may NOT be eligible if...** - You have metastatic (stage IV) breast cancer - You have a concurrent active cancer that could affect study safety - You have significant immune system problems or are taking medications that suppress your immune system - 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

PROCEDURELeukapheresis

Removal of white blood cells (leukocytes) from the blood. The dendritic cells are harvested from the white blood cells that are collected and trained to recognize the specific abnormal proteins found in the tumor sample. One needle is inserted in each arm. An apheresis machine removes blood from the vein in one arm, separates and retains the leukocytes from the blood, and then returns the rest of the blood to the other arm.

BIOLOGICALDendritic Cell (DC) Vaccine

The vaccine will be given intranodally (inguinal or axillary) under ultrasound guidance using a dose of 40-50 million cells three times spaced 2 weeks apart for the initial priming sequence. 3 doses of the priming vaccines are given once every 2 weeks. 2 booster shots (if available) will be given 6 months and 12 months following completion of initial priming vaccines.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT06435351


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