Personalized Dendritic Cell Vaccine Pilot for High-Risk TNBC

This pilot study is testing a personalized Dendritic Cell (DC) Vaccine for people with high-risk triple-negative breast cancer (TNBC) that remains after initial chemotherapy and surgery. The vaccine is made by taking your white blood cells (leukapheresis) and training them to recognize specific abnormal proteins from your tumor. You may be able to join if you have Stage II-III TNBC that is HER2 negative and has a significant amount of tumor remaining after standard chemotherapy and surgery. The main goal is to see how many patients can successfully receive at least one vaccine dose. The study aims to enroll 16 participants, but its current status is unclear.

Study design: This is a pilot study, meaning it's an early-stage investigation. It plans to enroll 16 participants.
What's involved: You would undergo leukapheresis (a procedure to collect white blood cells) and receive three doses of the DC Vaccine, given every two weeks.
Compensation: Not stated in the trial record.
Follow-up: The study will measure successful vaccination for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

EARLY_PHASE1Ages 18+InterventionalTreatment

H. Lee Moffitt Cancer Center and Research Institute

~16 participants

Updated 2026-04-01 on ClinicalTrials.gov

What's tested:LeukapheresisDendritic Cell (DC) Vaccine

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Percentage of patients enrolled who successfully undergo at least one vaccination.

Measured over Up to 3 Years

Conditions

Breast Cancer

Triple Negative Breast Cancer

NCT06435351

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Moffitt Cancer Center
Tampa, Floridastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Hatem Soliman, MD · STUDY_DIRECTOR · Moffitt Cancer Center

Who to contact

Neveen Abdo

[email protected]

813-745-4412

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Patient has stage II-III ER/PR less than or equal to 10% HER2 negative by FISH and/or IHC breast cancer treated with standard of care neoadjuvant systemic chemotherapy and surgical resection with significant residual breast tumor (equivalent to RCB II or III) disease.

Patient has sufficient residual viable primary breast tumor or ipsilateral breast axillary nodal metastatic cancer tissue accessible to Moffitt for whole exome sequencing.

Patient is 18 years of age or older.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Patients must have adequate organ and marrow function.

Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Patients without radiologic evidence of active metastatic disease and who are within 18 months of their last dose curative intent chemotherapy and/or radiotherapy (whichever is later) for the purposes of study enrollment.

Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Patients with known active locally advanced unresectable or metastatic cancer.

Patients with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the Principal Investigator (PI).

Patients who have a medical issue in the opinion of the treating physician and/or PI that would make them unsuitable for pheresis.

Patients who are currently receiving any other investigational agents.

Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant women are excluded from this study.

What this trial measures

Percentage of patients enrolled who successfully undergo at least one vaccination.Up to 3 Years
Successful production and administration of DC1 priming vaccination sequence in greater than 60% of patients enrolled.

Trialytics