[{"id":"d62d79f2-de52-4433-b2e3-056a8d934f77","acronym":"","url":"https://clinicaltrials.gov/study/NCT02650648","created_at":"2021-01-18T12:54:13.814Z","updated_at":"2025-02-25T16:51:37.215Z","phase":"Phase 1","brief_title":"Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma","source_id_and_acronym":"NCT02650648","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cyclophosphamide • Danyelza (naxitamab-gqgk) • cyclophosphamide intravenous"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 85","initiation":"Initiation: 01/01/2016","start_date":" 01/01/2016","primary_txt":" Primary completion: 01/01/2026","primary_completion_date":" 01/01/2026","study_txt":" Completion: 01/01/2026","study_completion_date":" 01/01/2026","last_update_posted":"2025-02-04"},{"id":"40e5938b-ca20-48e3-a63c-9af4d6ee2171","acronym":"","url":"https://clinicaltrials.gov/study/NCT05489887","created_at":"2022-08-05T13:57:17.217Z","updated_at":"2024-07-02T16:35:11.027Z","phase":"Phase 2","brief_title":"Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma","source_id_and_acronym":"NCT05489887","lead_sponsor":"Giselle Sholler","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Zykadia (ceritinib) • Danyelza (naxitamab-gqgk)"],"overall_status":"Recruiting","enrollment":" Enrollment 76","initiation":"Initiation: 09/14/2022","start_date":" 09/14/2022","primary_txt":" Primary completion: 09/01/2026","primary_completion_date":" 09/01/2026","study_txt":" Completion: 09/01/2033","study_completion_date":" 09/01/2033","last_update_posted":"2024-04-08"},{"id":"f04b08fb-05c4-417b-89d2-7c1a679e6dfa","acronym":"","url":"https://clinicaltrials.gov/study/NCT06026657","created_at":"2023-09-07T16:09:37.228Z","updated_at":"2024-07-02T16:35:19.941Z","phase":"Phase 1/2","brief_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","source_id_and_acronym":"NCT06026657","lead_sponsor":"Margaret Gatti-Mays","biomarkers":" HER-2 • CD4","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2 • CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e gemcitabine • Danyelza (naxitamab-gqgk) • UD TGFbetai NK cells"],"overall_status":"Recruiting","enrollment":" Enrollment 42","initiation":"Initiation: 03/01/2024","start_date":" 03/01/2024","primary_txt":" Primary completion: 12/31/2024","primary_completion_date":" 12/31/2024","study_txt":" Completion: 12/31/2024","study_completion_date":" 12/31/2024","last_update_posted":"2024-02-09"},{"id":"1548a7fc-808b-4731-ad11-a152caa3d099","acronym":"","url":"https://clinicaltrials.gov/study/NCT01757626","created_at":"2021-01-18T07:43:18.642Z","updated_at":"2024-07-02T16:35:24.430Z","phase":"Phase 1/2","brief_title":"Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma","source_id_and_acronym":"NCT01757626","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYC • MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYC • MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cyclophosphamide • irinotecan • Danyelza (naxitamab-gqgk)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 186","initiation":"Initiation: 12/01/2012","start_date":" 12/01/2012","primary_txt":" Primary completion: 12/01/2025","primary_completion_date":" 12/01/2025","study_txt":" Completion: 12/01/2025","study_completion_date":" 12/01/2025","last_update_posted":"2024-01-05"},{"id":"5c8aa60b-8029-4d17-8c03-63f6be45b9c1","acronym":"","url":"https://clinicaltrials.gov/study/NCT02307630","created_at":"2021-01-18T10:54:15.107Z","updated_at":"2024-07-02T16:35:27.312Z","phase":"","brief_title":"PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study","source_id_and_acronym":"NCT02307630","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 7","initiation":"Initiation: 11/01/2014","start_date":" 11/01/2014","primary_txt":" Primary completion: 11/01/2024","primary_completion_date":" 11/01/2024","study_txt":" Completion: 11/01/2024","study_completion_date":" 11/01/2024","last_update_posted":"2023-12-04"},{"id":"c06bbde7-40d3-4c24-a98e-a145a3234682","acronym":"","url":"https://clinicaltrials.gov/study/NCT06047535","created_at":"2023-09-21T14:10:38.582Z","updated_at":"2024-07-02T16:35:36.136Z","phase":"Phase 4","brief_title":"Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.","source_id_and_acronym":"NCT06047535","lead_sponsor":"SciClone Pharmaceuticals","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 62","initiation":"Initiation: 10/31/2023","start_date":" 10/31/2023","primary_txt":" Primary completion: 06/15/2027","primary_completion_date":" 06/15/2027","study_txt":" Completion: 08/15/2027","study_completion_date":" 08/15/2027","last_update_posted":"2023-09-21"},{"id":"be735f41-9ebc-4ba1-a422-1f1f7ec73210","acronym":"","url":"https://clinicaltrials.gov/study/NCT03189706","created_at":"2021-01-18T15:43:36.159Z","updated_at":"2024-07-02T16:35:37.432Z","phase":"Phase 2","brief_title":"Study of Chemoimmunotherapy for High-Risk Neuroblastoma","source_id_and_acronym":"NCT03189706","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e temozolomide • irinotecan • Danyelza (naxitamab-gqgk) • Leukine (sargramostim)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 48","initiation":"Initiation: 06/12/2017","start_date":" 06/12/2017","primary_txt":" Primary completion: 06/01/2024","primary_completion_date":" 06/01/2024","study_txt":" Completion: 06/01/2024","study_completion_date":" 06/01/2024","last_update_posted":"2023-09-12"},{"id":"b43951c2-d035-4ac4-a373-57638cb2c0c5","acronym":"","url":"https://clinicaltrials.gov/study/NCT01419834","created_at":"2021-01-18T05:51:19.103Z","updated_at":"2024-07-02T16:35:41.012Z","phase":"Phase 1","brief_title":"Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors","source_id_and_acronym":"NCT01419834","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"Completed","enrollment":" Enrollment 68","initiation":"Initiation: 08/15/2011","start_date":" 08/15/2011","primary_txt":" Primary completion: 08/02/2023","primary_completion_date":" 08/02/2023","study_txt":" Completion: 08/02/2023","study_completion_date":" 08/02/2023","last_update_posted":"2023-08-04"},{"id":"777414e0-33d6-4c03-b13c-7509a25c621f","acronym":"","url":"https://clinicaltrials.gov/study/NCT03033303","created_at":"2021-01-18T14:55:47.386Z","updated_at":"2024-07-02T16:35:44.009Z","phase":"Phase 2","brief_title":"A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma","source_id_and_acronym":"NCT03033303","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 59","initiation":"Initiation: 01/23/2017","start_date":" 01/23/2017","primary_txt":" Primary completion: 06/01/2024","primary_completion_date":" 06/01/2024","study_txt":" Completion: 06/01/2024","study_completion_date":" 06/01/2024","last_update_posted":"2023-07-04"},{"id":"db7a27d9-1811-456f-a1ff-1b9c1b61c6d6","acronym":"","url":"https://clinicaltrials.gov/study/NCT04501757","created_at":"2021-01-18T21:33:47.318Z","updated_at":"2024-07-02T16:35:59.387Z","phase":"","brief_title":"Naxitamab and GM-CSF in People With Neuroblastoma","source_id_and_acronym":"NCT04501757","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"No Longer Available","enrollment":"","initiation":"","start_date":"","primary_txt":"","primary_completion_date":"","study_txt":"","study_completion_date":"","last_update_posted":"2022-12-08"},{"id":"bf481a16-f3cb-4579-bbe9-3ac0faf7e783","acronym":"","url":"https://clinicaltrials.gov/study/NCT04909515","created_at":"2021-06-01T17:53:40.828Z","updated_at":"2024-07-02T16:36:04.620Z","phase":"Phase 2","brief_title":"Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.","source_id_and_acronym":"NCT04909515","lead_sponsor":"Y-mAbs Therapeutics","biomarkers":" MYCN","pipe":"","alterations":" ","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 12/02/2021","start_date":" 12/02/2021","primary_txt":" Primary completion: 06/01/2026","primary_completion_date":" 06/01/2026","study_txt":" Completion: 04/01/2027","study_completion_date":" 04/01/2027","last_update_posted":"2022-09-01"},{"id":"565388b3-d167-4666-b216-b4226a4831f9","acronym":"","url":"https://clinicaltrials.gov/study/NCT01662804","created_at":"2021-01-18T07:11:03.134Z","updated_at":"2024-07-02T16:36:29.741Z","phase":"Phase 1","brief_title":"Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors","source_id_and_acronym":"NCT01662804","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" MYCN","pipe":" | ","alterations":" MYCN amplification","tags":["MYCN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYCN amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Danyelza (naxitamab-gqgk)"],"overall_status":"Completed","enrollment":" Enrollment 14","initiation":"Initiation: 08/06/2012","start_date":" 08/06/2012","primary_txt":" Primary completion: 05/25/2021","primary_completion_date":" 05/25/2021","study_txt":" Completion: 05/25/2021","study_completion_date":" 05/25/2021","last_update_posted":"2021-05-27"}]