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First received: August 30, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Anatomic Stage IV Breast Cancer AJCC v8

Study Type: INTERVENTIONAL


Official Title: Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGF?i Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs)

Brief Summary: 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…

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