RecruitingPhase 1Phase 2NCT06026657

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

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)


Sponsor

Margaret Gatti-Mays

Enrollment

42 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of a chemotherapy drug (gemcitabine) and donated immune cells called Natural Killer (NK) cells, with or without a targeted antibody (naxitamab/Danyelza), for people with metastatic HER2-negative breast cancer. The NK cells are specially grown to be more effective at fighting cancer. The cancer cells must express a surface protein called GD2 (common in triple-negative breast cancer). **You may be eligible if...** - You are 18 or older with metastatic, HER2-negative breast cancer (e.g., triple-negative breast cancer) - Your cancer is historically associated with GD2 expression (archival tissue required) - You have received at least one prior treatment for metastatic disease - Your blood counts, kidney, and liver function are within acceptable ranges - You have measurable tumors on scans **You may NOT be eligible if...** - You have active brain metastases without prior treatment or recent progression - You have an active autoimmune disease requiring systemic treatment - You have received chemotherapy or radiation in the past 3 weeks - You have had a recent heart attack, serious heart failure, or significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

DRUGGemcitabine

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALNaxitamab

Given IV

BIOLOGICALUniversal Donor Expanded TGF-beta-imprinted NK Cells

Given IV


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT06026657


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