Breast CancerEarly Phase 1NCT06435351
Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy
A Early Phase 1 study testing Leukapheresis and Dendritic Cell (DC) Vaccine in people with Breast Cancer and Triple Negative Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Leukapheresis and Dendritic Cell (DC) Vaccine
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to May 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Neveen Abdo, 813-745-4412, neveen.abdo@moffitt.org
Hatem Soliman, MD
About this study
Official title: Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy
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
- Being tested
- Leukapheresis, Dendritic Cell (DC) Vaccine
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeukapheresisProcedure or surgery
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) VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Dendritic Cell (DC) Vaccine | Experimental | 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. Receives: Procedure: Leukapheresis; Biological: Dendritic Cell (DC) Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 Years
Secondary outcomes (2)
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.
Measured: Up to 3 Years
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.
Measured: Up to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start12 Jun 2024
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatem Soliman, MD, Study director, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435351
- Sponsor's protocol ID
- MCC-23142
- Status last verified
- Mar 2026
- First submitted
- 24 May 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT06435351
- Acronym / sponsor ID
- MCC-23142
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dendritic Cell (DC) Vaccine | Experimental | Procedure: Leukapheresis, Biological: Dendritic Cell (DC) VaccineThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeukapheresisRemoval 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. | Procedure or surgery | Dendritic Cell (DC) Vaccine |
| Dendritic Cell (DC) 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. | Biological | Dendritic Cell (DC) Vaccine |
Primary outcome
Percentage of patients enrolled who successfully undergo at least one vaccination.
Time frame: Up to 3 Years
Successful production and administration of DC1 priming vaccination sequence in greater than 60% of patients enrolled.
2 secondary outcomes
Number of participants who achieve Immunogenicity after administration of vaccine
Time frame: Up to 3 Years
Disease Free Survival (DFS)
Time frame: Up to 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hatem Soliman, MD study director
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Leukapheresis and Dendritic Cell (DC) Vaccine in people with Breast Cancer and Triple Negative Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neveen Abdo (813-745-4412, neveen.abdo@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients enrolled who successfully undergo at least one vaccination. (time frame: Up to 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.