Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Leukapheresis
Procedure/SurgeryRemoval 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
Biological/VaccineThe 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.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Dendritic Cell (DC) VaccineExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of patients enrolled who successfully undergo at least one vaccination.
Successful production and administration of DC1 priming vaccination sequence in greater than 60% of patients enrolled.
Time frame
Up to 3 YearsSecondary outcomes
1
Number of participants who achieve Immunogenicity after administration of vaccine
Immunogenicity will be determined by ELISpot and reactive T-Cell Receptor (TCR) expansion. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
Time frame
Up to 3 Years2
Disease Free Survival (DFS)
Disease Free Survival will be measured as the length of time after treatment to cancer recurrence or death from any cause.
Time frame
Up to 3 YearsSponsors and contacts
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Source ClinicalTrials.gov