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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This phase Ib/II trial tests the safety, best dose and how well gemcitabine and ex vivo expanded allogenic universal donor TGFBi NK cells with or without naxitamab work for the treatment of patients with GD2 expressing, HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. TGFBi NK cells are manufactured cells that are a part of your natural immunity. NK cells can recognize missing or incorrect proteins on tumor cells and then eliminate these tumor cells and TGFBi NK cells are created to be able to better kill the tumor cells. Naxitamab is a monoclonal antibody that targets GD2, which is a protein or sugar present on tumor cells but not very commonly found on normal cells. This antibody helps draw the attention of the immune system to the tumor cells that have GD2 to help attack the tumor cells. Giving gemcitabine and TGFBi NK cells with or without naxitamab may kill more tumor cells in patients with metastatic GD2 expressing, HER2 negative breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rак piersi, który rozprzestrzeniał się na inne części ciała, bez nadmiaru białka HER2
- •Widoczne zmiany nowotworowe, które można zmierzyć na badaniach obrazowych
- •Poprzednie leczenie raka rozproszonego, które nie zadziałało lub było źle tolerowane
- •Wiek 18 lat lub więcej
- •Dobry ogólny stan zdrowia (ECOG 0-1)
- •Wystarczająca liczba białych krwinek, płytek krwi i hemoglobiny
- •Prawidłowa funkcja nerek i wątroby
- •Kobiety mogą być ciężarne lub próbować zajść w ciążę - muszą używać dwóch metod antykoncepcji przez czas badania i 7 miesięcy po ostatniej dawce leku
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 8, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Ohio State University Comprehensive Cancer Center
Columbus, United States
Trial contact
The Ohio State University Comprehensive Cancer Center
Amanda Kabetso
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.