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Anti-metabolites

Gemcitabine + NK Cells +/- Naxitamab for Breast Cancer

Phase 1 & 2

Recruiting

Led By Margaret E Gatti-Mays, MD MPH

Research Sponsored by Margaret Gatti-Mays

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year after completion of study medication

Awards & highlights

Study Summary

This trial tests a combo of drugs & manufactured cells to fight metastatic GD2+ HER2- breast cancer.

Who is the study for?

This trial is for adults with metastatic, GD2 expressing, HER2 negative breast cancer who've had at least one prior treatment. They must understand the study and consent to it, have good organ function and performance status, resolved any previous therapy side effects to a mild level, and agree to use effective contraception. Excluded are those with certain allergies, recent other cancers or treatments, brain metastases, severe heart conditions or infections.Check my eligibility

What is being tested?

The trial tests gemcitabine (a chemotherapy drug) combined with lab-grown NK cells that boost immune response against cancer cells. It also examines the addition of naxitamab—a monoclonal antibody targeting specific proteins on tumor cells—to this combination in patients whose tumors express a particular protein called GD2.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system's enhancement such as fever and fatigue; typical chemotherapy-related issues like nausea; blood cell count changes leading to increased infection risk; possible allergic reactions; and infusion-related responses from monoclonal antibodies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured using standard criteria.

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I have had at least one treatment for my cancer after it spread and either it didn't work or I couldn't tolerate it.

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I am fully active or can carry out light work.

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My kidney function is within the normal range.

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Any side effects from my previous treatments are mild.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after completion of study medication

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year after completion of study medication

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after completion of study medication for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Objective response rate

Secondary outcome measures

Progression free survival

Transforming growth factor beta imprinted natural killer (TGFBi NK) cell detection

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm IV (Gemcitabine, naxitamab, TGFBi x2)Experimental Treatment6 Interventions

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle followed by naxitamab IV over 30-60 minutes on days 1, 4, and 8 of each cycle. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive TGFBi NK cells IV over 10-30 minutes on day 16 and 18 of cycle 1. Patients undergo CT scan and blood sample collection and may undergo MRI throughout the study.

Group II: Arm III (Gemcitabine naxitamab, TGFBi)Experimental Treatment6 Interventions

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle followed by naxitamab IV over 30-60 minutes on days 1, 4, and 8 of each cycle. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive TGFBi NK cells IV over 10-30 minutes on day 16 of cycle 1. Patients undergo CT scan and blood sample collection and may undergo MRI throughout the study.

Group III: Arm II (Gemcitabine, TGFBi x2)Experimental Treatment5 Interventions

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive TGFBi NK cells IV over 10-30 minutes on day 16 and 18 of cycle 1. Patients undergo CT scan and blood sample collection and may undergo MRI throughout the study.

Group IV: Arm I (Gemcitabine, TGFBi)Experimental Treatment5 Interventions

Patients receive gemcitabine intravenously (IV) over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive TGFBi NK cells IV over 10-30 minutes on day 16 of cycle 1. Patients undergo CT scan and blood sample collection and may undergo MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Gemcitabine

2017

Completed Phase 3

~2070

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Margaret Gatti-MaysLead Sponsor

Margaret E Gatti-Mays, MD MPHPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this research endeavor for participants?

"As per clinicaltrials.gov, recruitment for this trial has ceased since August 30th of 2023; the study was initially posted on October 1st of that same year. Despite not actively seeking participants anymore, there are currently 2403 other trials recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Margaret Gatti-Mays 2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06026657.