Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

April 2, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions

Anatomic Stage IV Breast Cancer AJCC v8HER2-Negative Breast Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Gemcitabine

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Naxitamab

Given IV

BIOLOGICAL

Universal Donor Expanded TGF-beta-imprinted NK Cells

Given IV

Trial Locations (1)

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

All Listed Sponsors

lead

Margaret Gatti-Mays

OTHER