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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
HER2 FPBMC
DrugParticipants will receive 5 weekly infusions of HER2 FPBMC infusions followed by 4 additional infusions every other week.
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: HER2 FPBMCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limiting toxicities (DLTs)
DLTs in the dose escalation phase
Time frame
During the first 5 infusions (5 weeks) for each participantSecondary outcomes
1
Total cells collected
Total cells collected for each participant (for creation of cell product) at each timepoint for collection
Time frame
For each participant, prior to starting study treatment (induction) and then prior to boost/retreatment infusions (about 9-10 weeks later)2
Overall response rate
Percent of participants that have a response (complete or partial) to study treatment
Time frame
During and immediately after study treatment for each participant (a maximum of ~20 weeks)3
Progression free survival
Time from start of study treatment through first disease progression afterward (for each participant)
Time frame
For up to 3 years after last infusion for each participant (about 3 1/2 years)4
Overall survival
Time from start of study treatment through death from any cause (for each participant)
Time frame
For up to 3 years after last infusion for each participant (about 3 1/2 years)Sponsors and contacts
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Source ClinicalTrials.gov