NCT07441889
HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of VirginiaInvestigator-initiated
~23 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:HER2 FPBMC
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities (DLTs)
Measured over During the first 5 infusions (5 weeks) for each participant
Conditions
Where it's being run
1 sites across 1 statesVirginia1
Study leadership
- Paul Viscuse, MD · PRINCIPAL_INVESTIGATOR · University of Virginia
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 7. Agreement to adhere to Lifestyle Considerations throughout study duration 8. A diagnosis of either of the following:
Exclusion
Uncontrolled angina or severe ventricular arrhythmias
Clinically significant pericardial disease
History of myocardial infarction (MI) in the last year before registration
Class 3 or higher New York Heart Association Congestive Heart Failure 4. 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. 5. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration 6. Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis 7. Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus. 8. Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed) 9. Has an active infection requiring systemic therapy 10. A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy 11. Has a known history of active TB (Bacillus Tuberculosis) 12. Has received a live vaccine within 30 days of study registration. 13. Treatment with any investigational agent within 3 weeks prior to study registration 14. Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin 15. 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. 16. 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. 17. Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant
What this trial measures
- Dose limiting toxicities (DLTs)During the first 5 infusions (5 weeks) for each participant
DLTs in the dose escalation phase