{"preliminary_commentary":{"by_channel":{"bluesky_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NCT06026657","nct_id":"NCT06026657","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct06026657. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"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.","label":"Arm I (Gemcitabine, TGFBi)","type":"EXPERIMENTAL"},{"description":"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.","label":"Arm II (Gemcitabine, TGFBi x2)","type":"EXPERIMENTAL"},{"description":"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.","label":"Arm III (Gemcitabine naxitamab, TGFBi)","type":"EXPERIMENTAL"},{"description":"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.","label":"Arm IV (Gemcitabine, naxitamab, TGFBi x2)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-10-31","type":"ESTIMATED"},"conditions":["Anatomic Stage IV Breast Cancer AJCC v8","HER2-Negative Breast Carcinoma"],"enrollment":{"count":42,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Biospecimen Collection","otherNames":["Biological Sample Collection","Biospecimen Collected","Specimen Collection"],"type":"PROCEDURE"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","CT","CT Scan","tomography"],"type":"PROCEDURE"},{"name":"Gemcitabine","otherNames":["dFdC","dFdCyd","Difluorodeoxycytidine"],"type":"DRUG"},{"name":"Magnetic Resonance Imaging","otherNames":["Magnetic Resonance","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging"],"type":"PROCEDURE"},{"name":"Naxitamab","otherNames":["Anti-Gd2 IGG3 Monoclonal Antibody 3f8 Humanized","Danyelza","Hu3F8","Humanized Anti-GD2 Antibody 3F8","Humanized Monoclonal Antibody Hu3f8-IGG1"],"type":"BIOLOGICAL"},{"name":"Universal Donor Expanded TGF-beta-imprinted NK Cells","otherNames":["Allogeneic TGFBi Expanded NK Cells","UD TGF-betai NK Cells","Universal Donor TGF-beta Imprinted Expanded NK Cells"],"type":"BIOLOGICAL"}],"last_update":"2026-07-23","lead_sponsor":"Margaret Gatti-Mays","official_title":"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)","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-10-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Incidence of adverse events","timeFrame":"Up to 1 year after completion of study medication"},{"measure":"Objective response rate","timeFrame":"Up to 1 year after completion of study medication"}],"references":[],"start_date":{"date":"2024-04-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"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","url":"https://clinicaltrials.gov/study/NCT06026657"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct06026657"}