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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Procedure
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Contact Information
Primary
Neveen Abdo
neveen.abdo@moffitt.org
813-745-4412
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2029-05
Participants
Target number of participants: 16
Treatments
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.
Sponsors
Leads: H. Lee Moffitt Cancer Center and Research Institute

This content was sourced from clinicaltrials.gov