HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Uncontrolled angina or severe ventricular arrhythmias
Clinically significant pericardial disease
Trial design
Treatments tested in this trial
- HER2 FPBMC
Treatment groups
23 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov