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 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 pro

Trial Details

NCT ID
NCT06026657
Phase
PHASE1 / PHASE2
Sponsor
Margaret Gatti-Mays
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Gemcitabine
  • Magnetic Resonance Imaging
  • Naxitamab
  • Universal Donor Expanded TGF-beta-imprinted NK Cells
Locations (sample)
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Patients must have histologically or cytologically confirmed, HER2 negative metastatic breast cancer that is historically GD2 expressing (e.g., tri…
  • Patients must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for the evaluation of measurable disease
  • Patients must have received at least one prior treatment for metastatic disease and progressed on treatment or been intolerant to treatment
  • Female or male \>=18 years

For full eligibility, visit ClinicalTrials.gov.

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