HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)

NCT07441889 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 303019
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer; Prostate Cancer

Keywords

FPBMC

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicities (DLTs)

  DLTs in the dose escalation phase

  During the first 5 infusions (5 weeks) for each participant

Secondary Outcomes (8)

• Total cells collected

  For each participant, prior to starting study treatment (induction) and then prior to boost/retreatment infusions (about 9-10 weeks later)

• Overall response rate

  During and immediately after study treatment for each participant (a maximum of ~20 weeks)

• Progression free survival

  For up to 3 years after last infusion for each participant (about 3 1/2 years)

• Overall survival

  For up to 3 years after last infusion for each participant (about 3 1/2 years)

• Adverse events

  During and through ~30 days after end of study treatment (maximum of about 24 weeks)

Study Arms (1)

HER2 FPBMC

EXPERIMENTAL

Five weekly infusions of HER2 fresh peripheral blood mononuclear cells (FPBMC) followed by 4 HER2 FPBMC infusions every other week

Drug: HER2 FPBMC

Interventions

HER2 FPBMC DRUG

Participants will receive 5 weekly infusions of HER2 FPBMC infusions followed by 4 additional infusions every other week.

HER2 FPBMC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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:

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Virginia: lead

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Paul Viscuse, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Donihee

CONTACT

(434) 243-6377; ZWZ6JM@uvahealth.org

Lavanya Shenoy

CONTACT

(434) 243-7028; rtm7ht@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2032
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share