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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07441889
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2032

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Dose limiting toxicities (DLTs) [ Time Frame: During the first 5 infusions (5 weeks) for each participant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Ashley Lamont
[email protected]
434-409-5009
Laura Livingston
[email protected]
434-882-5578
Paul Viscuse, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
Breast cancerProstate cancer
By specialty
OncologyBreast oncologyWomen's healthProstate oncologyMen's healthUrology
By research site
University of Virginia· Charlottesville, VA

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