# 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

> **NCT06026657** · PHASE1,PHASE2 · RECRUITING · sponsor: **Margaret Gatti-Mays** · enrollment: 42 (estimated)

## Conditions studied

- Anatomic Stage IV Breast Cancer AJCC v8
- HER2-Negative Breast Carcinoma

## Interventions

- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Computed Tomography
- **DRUG:** Gemcitabine
- **PROCEDURE:** Magnetic Resonance Imaging
- **BIOLOGICAL:** Naxitamab
- **BIOLOGICAL:** Universal Donor Expanded TGF-beta-imprinted NK Cells

## Key facts

- **NCT ID:** NCT06026657
- **Lead sponsor:** Margaret Gatti-Mays
- **Sponsor class:** OTHER
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2024-04-02
- **Primary completion:** 2026-12-31
- **Final completion:** 2026-12-31
- **Target enrollment:** 42 (ESTIMATED)
- **Last updated:** 2025-07-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06026657

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06026657, "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". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT06026657. Licensed CC0.

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