Breast CancerPhase 1/2NCT07441889
HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)
A Phase 1/2 study testing HER2 FPBMC in people with Breast Cancer and Prostate Cancer, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to understand the safety and estimate the efficacy of anti-CD3 x anti-HER2 bispecific antibody (HER2Bi) armed fresh peripheral blood mononuclear cells (HER2 FPBMC) for patients with metastatic breast or prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- What is being tested?
- HER2 FPBMC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Oct 2032
- Phase
- Phase 1/2
- 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years at the time of signing informed consent
- Expected survival ≥ 3 months in the judgment of the investigator
- ECOG PS 0-1
- Adequate Organ Function per the following criteria (within 10 days of study registration):
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- Absolute lymphocyte count ≥ 400/mm3
- Absolute neutrophil count ≥ 1000/mm3
- Platelets ≥ 75,000/mm3
- Hemoglobin ≥ 9g/dL
- Serum creatinine < 2.0 mg/dL OR measured or calculated creatinine clearance ≥ 50 ml/mm
- Total bilirubin ≤ mg/dL
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 5.0 times normal
- Agreement to adhere to Lifestyle Considerations throughout study duration
- A diagnosis of either of the following:
- Prostate Cancer: i. Histological and/or cytological confirmation of prostate adenocarcinoma. ii. Participants must have progressive mCRPC at screening iii. Serum testosterone levels <50 ng/dL during screening. iv. Must have progressed on at least one prior ARPI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide).
- Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration.
- Breast Cancer i. Histological and/or cytological confirmation of invasive breast cancer. ii. Participants must have previously treated metastatic breast cancer at screening. Metastatic breast cancer must be evaluable by RECIST 1.1 criteria.
- Must have progressed on at least two prior endocrine or targeted therapies or at least two lines of cytotoxic chemotherapy. If HER2 positive, then must have progressed on or been intolerant of at least one HER2 targeted therapy.
- Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration.
Who cannot join
- Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation
- History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week
- Inadequate cardiac function, as defined as any of the following:
- Uncontrolled angina or severe ventricular arrhythmias
- Clinically significant pericardial disease
- History of myocardial infarction (MI) in the last year before registration
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- Class 3 or higher New York Heart Association Congestive Heart Failure
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration
- Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
- Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus.
- Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
- Has an active infection requiring systemic therapy
- A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy
- Has a known history of active TB (Bacillus Tuberculosis)
- Has received a live vaccine within 30 days of study registration.
- Treatment with any investigational agent within 3 weeks prior to study registration
- Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin
- Has active autoimmune disease that has required systemic treatment in the 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant
- Additional Exclusion Criteria for Patients with Prostate Cancer:
- Has small cell neuroendocrine carcinoma (pure or mixed) on prior or current histologic evaluation of primary or metastatic lesions
- Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible.
- Additional Exclusion Criteria for Patients with Breast Cancer:
- Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible.
- Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and peritoneal), pulmonary lymphangitis, or liver involvement > 50%.
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
University of Virginia
Charlottesville, Virginia, 22903
Ashley Lamont, 434-409-5009, zwz6jm@UVAHealth.org
Laura Livingston, 434-882-5578, LL9TE@uvahealth.org
About this study
Official title: Phase I/II Study of Anti-CD3 x Anti-HER2 Bispecific Antibody (HER2Bi) Armed Fresh Peripheral Blood Mononuclear Cells (HER2 FPBMC) in Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Breast Cancer (MBC)
The purpose of this study is to understand the safety and estimate the efficacy of anti-CD3 x anti-HER2 bispecific antibody (HER2Bi) armed fresh peripheral blood mononuclear cells (HER2 FPBMC) for patients with metastatic breast or prostate cancer. Participants receive 5 weekly doses of CD33 FPBMC by intravenous infusion followed by 4 infusions every other week.
Read the detailed description
Once subjects are determined to be eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The T cells in the mononuclear cells are coated with bispecific antibody to activate the T cells and the mononuclear cells are re-infused into the patients so the T cells can multiply and kill cancer cells. At least 72 hours after the leukapheresis procedure, study treatment will start. After 5 HER2 FPBMC infusions, participants will have another leukapheresis procedure. Before, throughout and following study treatment, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- HER2 FPBMC
- Keywords
- FPBMC
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2 FPBMCDrug
Participants will receive 5 weekly infusions of HER2 FPBMC infusions followed by 4 additional infusions every other week.
| Study group | Role | What they receive |
|---|---|---|
| HER2 FPBMC | Experimental | Five weekly infusions of HER2 fresh peripheral blood mononuclear cells (FPBMC) followed by 4 HER2 FPBMC infusions every other week Receives: Drug: HER2 FPBMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLTs)
DLTs in the dose escalation phase
Measured: During the first 5 infusions (5 weeks) for each participant
Secondary outcomes (8)
Total cells collected
Total cells collected for each participant (for creation of cell product) at each timepoint for collection
Measured: For each participant, prior to starting study treatment (induction) and then prior to boost/retreatment infusions (about 9-10 weeks later)
Overall response rate
Percent of participants that have a response (complete or partial) to study treatment
Measured: During and immediately after study treatment for each participant (a maximum of ~20 weeks)
Progression free survival
Time from start of study treatment through first disease progression afterward (for each participant)
Measured: For up to 3 years after last infusion for each participant (about 3 1/2 years)
Overall survival
Time from start of study treatment through death from any cause (for each participant)
Measured: For up to 3 years after last infusion for each participant (about 3 1/2 years)
Adverse events
As described using CTCAE v5.0
Measured: During and through ~30 days after end of study treatment (maximum of about 24 weeks)
Development of specific cytotoxicity by PBMCs (of participants) as measured by cytotoxicity or IFN-γ EliSpots responses
To breast and prostate cancer cell lines, respectively
Measured: Multiple timepoints during and through ~30 days after end of study treatment (maximum of about 24 weeks)
Serum antibodies to breast or prostate cancer cell lines and ELISA for IgG-specific antibody to HER2 and EGFR2
Measured: Multiple timepoints during and through ~30 days after end of study treatment (maximum of about 24 weeks)
Survival kinetics of HER2 FPBMCs after a single infusion
Measured: Multiple timepoints before and after the first 5 infusions (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2032 (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 University of VirginiaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Viscuse, University of Virginia
- Investigators
- Paul Viscuse, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441889
- Sponsor's protocol ID
- 303019
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2026
- Last updated
- 12 Jun 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Anti-CD3 x Anti-HER2 Bispecific Antibody (HER2Bi) Armed Fresh Peripheral Blood Mononuclear Cells (HER2 FPBMC) in Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT07441889
- Acronym / sponsor ID
- 303019
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- FPBMC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 2 Mar 2026 (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 understand the safety and estimate the efficacy of anti-CD3 x anti-HER2 bispecific antibody (HER2Bi) armed fresh peripheral blood mononuclear cells (HER2 FPBMC) for patients with metastatic breast or prostate cancer. Participants receive 5 weekly doses of CD33 FPBMC by intravenous infusion followed by 4 infusions every other week.
Detailed description
Once subjects are determined to be eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The T cells in the mononuclear cells are coated with bispecific antibody to activate the T cells and the mononuclear cells are re-infused into the patients so the T cells can multiply and kill cancer cells. At least 72 hours after the leukapheresis procedure, study treatment will start. After 5 HER2 FPBMC infusions, participants will have another leukapheresis procedure. Before, throughout and following study treatment, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2 FPBMC | Experimental | Drug: HER2 FPBMCFive weekly infusions of HER2 fresh peripheral blood mononuclear cells (FPBMC) followed by 4 HER2 FPBMC infusions every other week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years at the time of signing informed consent
- Expected survival ≥ 3 months in the judgment of the investigator
- ECOG PS 0-1
Key exclusion criteria (27 listed)
- Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation
- History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week
- Inadequate cardiac function, as defined as any of the following:
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration
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 |
|---|---|---|
| HER2 FPBMCParticipants will receive 5 weekly infusions of HER2 FPBMC infusions followed by 4 additional infusions every other week. | Drug | HER2 FPBMC |
Primary outcome
Dose limiting toxicities (DLTs)
Time frame: During the first 5 infusions (5 weeks) for each participant
DLTs in the dose escalation phase
8 secondary outcomes
Total cells collected
Time frame: For each participant, prior to starting study treatment (induction) and then prior to boost/retreatment infusions (about 9-10 weeks later)
Overall response rate
Time frame: During and immediately after study treatment for each participant (a maximum of ~20 weeks)
Progression free survival
Time frame: For up to 3 years after last infusion for each participant (about 3 1/2 years)
Overall survival
Time frame: For up to 3 years after last infusion for each participant (about 3 1/2 years)
Adverse events
Time frame: During and through ~30 days after end of study treatment (maximum of about 24 weeks)
Development of specific cytotoxicity by PBMCs (of participants) as measured by cytotoxicity or IFN-γ EliSpots responses
Time frame: Multiple timepoints during and through ~30 days after end of study treatment (maximum of about 24 weeks)
Serum antibodies to breast or prostate cancer cell lines and ELISA for IgG-specific antibody to HER2 and EGFR2
Time frame: Multiple timepoints during and through ~30 days after end of study treatment (maximum of about 24 weeks)
Survival kinetics of HER2 FPBMCs after a single infusion
Time frame: Multiple timepoints before and after the first 5 infusions (week 5)
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 12 Jun 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.
Paul Viscuse, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HER2 FPBMC in people with Breast Cancer and Prostate Cancer, run by University of Virginia 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 20 inclusion and 27 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 12 Jun 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ashley Lamont ((434) 243-6377, ZWZ6JM@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities (DLTs) (time frame: During the first 5 infusions (5 weeks) for each participant). 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 12 Jun 2026.