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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Jan 2025

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At a glance

  • Drugs Gemcitabine (Primary) ; Natural killer cell therapy (Primary) ; Naxitamab (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms DiG NKs

Most Recent Events

  • 08 Jan 2025 Planned End Date changed from 31 Dec 2024 to 31 Dec 2026.
  • 08 Jan 2025 Planned primary completion date changed from 31 Dec 2024 to 31 Dec 2026.
  • 13 Dec 2024 Planned number of patients changed from 42 to 45.

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