HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006) (NCT07441889) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)
23 participantsStarted 2026-04
Plain-language 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. Participants receive 5 weekly doses of CD33 FPBMC by intravenous infusion followed by 4 infusions every other week.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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):
✓. Agreement to adhere to Lifestyle Considerations throughout study duration
✓. A diagnosis of either of the following:
Exclusion criteria
✕. 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.
What they're measuring
1
Dose limiting toxicities (DLTs)
Timeframe: During the first 5 infusions (5 weeks) for each participant
✕. 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)