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

NCT07441889 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-03-02

No results posted yet for this study

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

Interventions

DRUG

HER2 FPBMC

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

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Paul Viscuse, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-06-30
Completion
2032-06-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441889 on ClinicalTrials.gov