NCT07441889

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

Phase I/II Study of Anti-CD3 x Anti-HER2 Bispecific Antibody (HER2Bi) Armed Fresh Peripheral Blood Mononuclear Cells (HER2 FPBMC) in Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Breast Cancer (MBC)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Once subjects are determined to be eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The T cells in the mononuclear cells are coated with bispecific antibody to activate the T cells and the mononuclear cells are re-infused into the patients so the T cells can multiply and kill cancer cells. At least 72 hours after the leukapheresis procedure, study treatment will start. After 5 HER2 FPBMC infusions, participants will have another leukapheresis procedure. Before, throughout and following study treatment, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.

Conditions

• Breast Cancer
• Prostate Cancer

Interventions

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

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-06-01
• Completion: 2032-06-01
• First posted: 2026-03-02
• Last updated: 2026-03-02

Regulatory

• FDA-regulated drug study