drugset / Trial / NCT07441889

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

NCT07441889 ↗

Phase 1/2 Recruiting 23 enrolled University of Virginia
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-06
Primary completion
2029-10
Completion
2032-10

Drugs

EvaluationDrugModalityDoseRoute
Subject HER2 FPBMC Cell therapy — Intravenous