Recruiting
Early Phase 1

Personalized Vaccine

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06435351

Conditions

Breast Cancer

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Leukapheresis

Dendritic Cell (DC) Vaccine

Study Details

Brief 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.

Conditions

Breast Cancer

Triple Negative Breast Cancer

Study ID

NCT06435351

Start date

Jun 12, 2024

Status verified date

Mar, 2026

Completion date

May, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dendritic Cell (DC) Vaccine

The tumor specimen collected from the primary tumor will undergo whole exome sequencing (WES). The WES data will be analyzed to select up to 20 neoantigens. From this screen up to 10 peptides will be selected to be synthesized for testing and use on the DC pheresis product that will be collected.

The ready vaccine product will be cryopreserved and then thawed once the patient is ready to under the vaccination sequence.

Interventions

Leukapheresis

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.

Dendritic 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.

Primary outcome measure

  • Percentage of patients enrolled who successfully undergo at least one vaccination. [ Time Frame: Up to 3 Years ]

Central Contacts and Locations

Central contacts

Neveen Abdo

813-745-4412neveen.abdo@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Neveen Abdo

813-745-4412neveen.abdo@moffitt.org

Principal Investigator:

Hatem Soliman, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-04-01.