HER2-positive Breast CancerPhase 1NCT05378464
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
A Phase 1 study testing Dendritic Cell (DC1) Vaccine, Trastuzumab and Pepinemab in people with HER2-positive Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Dendritic Cell (DC1) Vaccine, Trastuzumab and Pepinemab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to Dec 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Must have a histologically confirmed HER2 positive breast cancer and must be candidates for trastuzumab therapy as per current standard of care. Note: HER2 positive breast cancer is defined by tumor tissue HER2 overexpression and or tumor HER2 amplification per ASCO/CAP criteria.
- Patients will be eligible regardless of ER/PR status which will be determined per 2020 ASCO/CAP guideline and hormonal therapy will be allowed to continue for patients with ER/PR positive disease.
- Must have evaluable disease, defined as at least one lesion that can be accurately measured ≥ 10 mm by standard imaging techniques that can be include but not limited to CT, PET, PET/CT, MRI. Skeletal disease which is measurable by PET/CT or bone scan will also be allowed.
- Must have had disease progression while on trastuzumab for the treatment of HER2+ MBC and received no more than 3 lines of cytotoxic chemotherapy in the setting of metastatic disease.
- ECOG performance status 0 or 1.
- Must have normal organ and marrow function as defined in protocol within 14 days of registration.
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- Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan)
- Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum or urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose. To be considered of not to be of childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (not in the setting of post chemotherapy) or patients must be surgically sterile.
- Must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.
- Must have a life expectancy of at least 12 weeks.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 14 days prior to beginning protocol therapy.
- Patients may not be receiving any other investigational agents within 14 days or 5 half-lives (whichever is longer) prior to beginning protocol therapy.
- Patients with uncontrolled brain metastases or leptomeningeal disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded.
- Female patients who are pregnant or nursing are not eligible.
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- Second invasive malignancy requiring active treatment
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) is not permitted.
- Any known positive test for Hepatitis B or Hepatitis C virus indicating acute or chronic infection is not permitted.
- Patients who have received a live attenuated vaccine ≤30 days of registration are not eligible.
- Patients not able to comply with the treatment schedule and study procedures for any reason are not eligible.
- Patients previously treated with any form of adoptive cell transfer therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer
The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.
Read the detailed description
Patients with HER2-positive (HER2+) metastatic breast cancer will be treated with 6 weekly injections of dendritic cell (DC1) vaccines in combination with trastuzumab and pepinemab.
Investigators hypothesize these therapies will elicit CD4+ HER2 specific T cell responses. HER2 specific T cells will be expanded ex vivo which will be infused to patients subsequently following lymphodepletion therapy with cyclophosphamide. Trastuzumab and pepinemab will be given as maintenance in addition to booster DC1 vaccines.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Dendritic Cell (DC1) Vaccine, Trastuzumab, Pepinemab, T-Cell therapy
- Keywords
- Breast Cancer, T-Cell therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cell (DC1) VaccineBiological
Participants will receive a DC1 vaccine injection at 1.0-2.0 x 10^7 cells, either to groin lymph notes or to tumor if accessible once a week for 3 weeks on days 1, 8 and 15. Participants will receive DC1 vaccine boosters every 3 weeks x 3.
TrastuzumabDrug
Also called Herceptin, Trazimera
Participants will receive trastuzumab 8 mg/kg by IV week 1, then 6 mg/kg by IV beginning week 4 and continuing every 3 weeks until disease progression or intolerable toxicity.
PepinemabDrug
Participants will receive pepinemab 20 mg/kg by IV beginning week 1 and continuing every 3 weeks until disease progression or intolerable toxicity.
T-Cell therapyBiological
Participants will receive IL-15 expanded CD4 T cells infusion by IV Day 1 at week 8, 2 weeks from last DC1 vaccine, and IL-7 expanded CD4 T cells infusion IV at week 8 day 8.
| Study group | Role | What they receive |
|---|---|---|
| T-Cell therapy dose level 1 | Experimental | Participants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with IL-15 Expanded HER2 specific CD4+ Th1 cell 0.5.0-2.5 x 10^8, IL-7 and Expanded HER2 specific CD4+ Th1 cell 0.5.0-2.5 x 10^8. Receives: Biological: Dendritic Cell (DC1) Vaccine; Drug: Trastuzumab; Drug: Pepinemab; Biological: T-Cell therapy |
| T-Cell therapy dose level 2 | Experimental | Participants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with IL-15 Expanded HER2 specific CD4+ Th1 cell .25-1.2 x 10^9, IL-7 and Expanded HER2 specific CD4+ Th1 cell .25-1.2 x 10^9. Receives: Biological: Dendritic Cell (DC1) Vaccine; Drug: Trastuzumab; Drug: Pepinemab; Biological: T-Cell therapy |
| T-Cell therapy dose level 3 | Experimental | Participants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with IL-15 Expanded HER2 specific CD4+ Th1 cell .5-2.5 x 10^9, IL-7 and Expanded HER2 specific CD4+ Th1 cell .5-2.5 x 10^9. Receives: Biological: Dendritic Cell (DC1) Vaccine; Drug: Trastuzumab; Drug: Pepinemab; Biological: T-Cell therapy |
| T Cell therapy dose expansion | Experimental | Participants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with CD4 treated t-cells at the maximum tolerated dose determined. Receives: Biological: Dendritic Cell (DC1) Vaccine; Drug: Trastuzumab; Drug: Pepinemab; Biological: T-Cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of expanded CD4 T cells
MTD of expanded CD4 T cells after treatment with DC1 vaccines and trastuzumab/pepinemab.
Measured: Up to 6 months
Secondary outcomes (4)
Overall Response Rate (ORR)
ORR according to RECIST criteria v1.1 and iRECIST of treatment DC1 vaccines and pepinemab/trastuzumab
Measured: Up to 6 months
Clinical Benefit Rate (CBR) of DC1 vaccines and pepinemab/trastuzumab
To assess the 6-month clinical benefit rate (CBR) according to RECIST criteria v. 1.1 of treatment with DC1 vaccines and pepinemab/trastuzumab
Measured: at 6 months
Clinical Benefit Rate (CBR) of expanded CD4 T Cells
To assess the 6-month CBR according to RECIST criteria v. 1.1 of treatment with expanded CD4+ T cells following DC1 vaccines and pepinemab/trastuzumab.
Measured: at 6 months
Progression Free Survival (PFS)
PFS is defined as the length of time from start of treatment to progression or death.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start31 May 2022
- Primary completion17 Aug 2026
- Study completionDec 2026 (estimated)
Why it stopped: Wait for the DLT period with our current patient and will not be enrolling any more.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vaccinex Inc.
- Responsible party
- Sponsor
- Investigators
- Heather Han, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378464
- Sponsor's protocol ID
- MCC-21378
- Status last verified
- Sep 2026
- First submitted
- 12 May 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT05378464
- Acronym / sponsor ID
- MCC-21378
- Conditions
- HER2-positive Breast Cancer
- Keywords
- Breast Cancer, T-Cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Wait for the DLT period with our current patient and will not be enrolling any more.
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Vaccinex Inc.
- Study start
- 31 May 2022 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 May 2022 (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.
The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.
Detailed description
Patients with HER2-positive (HER2+) metastatic breast cancer will be treated with 6 weekly injections of dendritic cell (DC1) vaccines in combination with trastuzumab and pepinemab.
Investigators hypothesize these therapies will elicit CD4+ HER2 specific T cell responses. HER2 specific T cells will be expanded ex vivo which will be infused to patients subsequently following lymphodepletion therapy with cyclophosphamide. Trastuzumab and pepinemab will be given as maintenance in addition to booster DC1 vaccines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T-Cell therapy dose level 1 | Experimental | Biological: Dendritic Cell (DC1) Vaccine, Drug: Trastuzumab, Drug: Pepinemab, Biological: T-Cell therapyParticipants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with IL-15 Expanded HER2 specific CD4+ Th1 cell 0.5.0-2.5 x 10^8, IL-7 and Expanded HER2 specific CD4+ Th1 cell 0.5.0-2.5 x 10^8. |
| T-Cell therapy dose level 2 | Experimental | Biological: Dendritic Cell (DC1) Vaccine, Drug: Trastuzumab, Drug: Pepinemab, Biological: T-Cell therapyParticipants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with IL-15 Expanded HER2 specific CD4+ Th1 cell .25-1.2 x 10^9, IL-7 and Expanded HER2 specific CD4+ Th1 cell .25-1.2 x 10^9. |
| T-Cell therapy dose level 3 | Experimental | Biological: Dendritic Cell (DC1) Vaccine, Drug: Trastuzumab, Drug: Pepinemab, Biological: T-Cell therapyParticipants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with IL-15 Expanded HER2 specific CD4+ Th1 cell .5-2.5 x 10^9, IL-7 and Expanded HER2 specific CD4+ Th1 cell .5-2.5 x 10^9. |
| T Cell therapy dose expansion | Experimental | Biological: Dendritic Cell (DC1) Vaccine, Drug: Trastuzumab, Drug: Pepinemab, Biological: T-Cell therapyParticipants will begin treatment with pepinemab and trastuzumab, and begin DC1 vaccines. After 6 weeks of DC1 vaccines, blood will be collected for t-cell therapy, and patients will then be treated with CD4 treated t-cells at the maximum tolerated dose determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must have a histologically confirmed HER2 positive breast cancer and must be candidates for trastuzumab therapy as per current standard of care. Note: HER2 positive breast cancer is defined by tumor tissue HER2 overexpression and or tumor HER2 amplification per ASCO/CAP criteria.
- Patients will be eligible regardless of ER/PR status which will be determined per 2020 ASCO/CAP guideline and hormonal therapy will be allowed to continue for patients with ER/PR positive disease.
- Must have evaluable disease, defined as at least one lesion that can be accurately measured ≥ 10 mm by standard imaging techniques that can be include but not limited to CT, PET, PET/CT, MRI. Skeletal disease which is measurable by PET/CT or bone scan will also be allowed.
- Must have had disease progression while on trastuzumab for the treatment of HER2+ MBC and received no more than 3 lines of cytotoxic chemotherapy in the setting of metastatic disease.
- ECOG performance status 0 or 1.
Key exclusion criteria (12 listed)
- Patients who have had chemotherapy or radiotherapy within 14 days prior to beginning protocol therapy.
- Patients may not be receiving any other investigational agents within 14 days or 5 half-lives (whichever is longer) prior to beginning protocol therapy.
- Patients with uncontrolled brain metastases or leptomeningeal disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded.
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 |
|---|---|---|
| Dendritic Cell (DC1) VaccineParticipants will receive a DC1 vaccine injection at 1.0-2.0 x 10^7 cells, either to groin lymph notes or to tumor if accessible once a week for 3 weeks on days 1, 8 and 15. Participants will receive DC1 vaccine boosters every 3 weeks x 3. | Biological | T Cell therapy dose expansion, T-Cell therapy dose level 1, T-Cell therapy dose level 2, T-Cell therapy dose level 3 |
| TrastuzumabAlso: Herceptin, TrazimeraParticipants will receive trastuzumab 8 mg/kg by IV week 1, then 6 mg/kg by IV beginning week 4 and continuing every 3 weeks until disease progression or intolerable toxicity. | Drug | T Cell therapy dose expansion, T-Cell therapy dose level 1, T-Cell therapy dose level 2, T-Cell therapy dose level 3 |
| PepinemabParticipants will receive pepinemab 20 mg/kg by IV beginning week 1 and continuing every 3 weeks until disease progression or intolerable toxicity. | Drug | T Cell therapy dose expansion, T-Cell therapy dose level 1, T-Cell therapy dose level 2, T-Cell therapy dose level 3 |
| T-Cell therapyParticipants will receive IL-15 expanded CD4 T cells infusion by IV Day 1 at week 8, 2 weeks from last DC1 vaccine, and IL-7 expanded CD4 T cells infusion IV at week 8 day 8. | Biological | T Cell therapy dose expansion, T-Cell therapy dose level 1, T-Cell therapy dose level 2, T-Cell therapy dose level 3 |
Primary outcome
Maximum Tolerated Dose (MTD) of expanded CD4 T cells
Time frame: Up to 6 months
MTD of expanded CD4 T cells after treatment with DC1 vaccines and trastuzumab/pepinemab.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 6 months
Clinical Benefit Rate (CBR) of DC1 vaccines and pepinemab/trastuzumab
Time frame: at 6 months
Clinical Benefit Rate (CBR) of expanded CD4 T Cells
Time frame: at 6 months
Progression Free Survival (PFS)
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Heather Han, MD principal investigator
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 Phase 1 study testing Dendritic Cell (DC1) Vaccine, Trastuzumab and Pepinemab in people with HER2-positive 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 10 inclusion and 12 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: paused, as of the sponsor's last update on 15 Sep 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of expanded CD4 T cells (time frame: Up to 6 months). 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 15 Sep 2026.