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NCT04501757

Naxitamab and GM-CSF in People With Neuroblastoma

NO LONGER AVAILABLE Last updated 8 December 2022
What this trial tests

trial testing Naxitamab/GM-CSF in High-Risk Neuroblastoma. No longer available.

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
StatusNO LONGER AVAILABLE
Study typeEXPANDED_ACCESS
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 Months and older, any sex, with High-Risk Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an Expanded Access Program (EAP) that will give the participants access to the drug naxitamab before it is approved by the FDA. Naxitamab will be combined with granulocyte-macrophage colony stimulating factor (GM-CSF). Participants in this study will have high-risk neuroblastoma that either went away completely after treatment (complete remission) or has come back (relapsed/refractory). Researchers think the combination of naxitamab and GM-CSF will be effective because naxitamab and GM-CSF strengthen the immune system's response to cancer cells in different ways. Naxitamab is an antibody, like the proteins made by the immune system to protect the body from harm. Naxitamab helps the cells of the immune system to find and attack cancer cells. GM-CSF is a protein that strengthens the immune system by increasing the number of immune cells called granulocytes. Granulocytes are white blood cells that fight off cancer cells. The combination of naxitamab and GM-CSF is a type of immunotherapy.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Anti-glycan monoclonal antibodies: Basic research and clinical applications.
    Gillmann KM, Temme JS, Marglous S, Brown CE, et al · · 2023 · cited 25× · PMID 36905763 · DOI 10.1016/j.cbpa.2023.102281
  2. Neuroblastoma: an ongoing cold front for cancer immunotherapy.
    Kennedy PT, Zannoupa D, Son MH, Dahal LN, et al · · 2023 · cited 19× · PMID 37993280 · DOI 10.1136/jitc-2023-007798
  3. The Neuroblastoma Microenvironment, Heterogeneity and Immunotherapeutic Approaches.
    Polychronopoulos PA, Bedoya-Reina OC, Johnsen JI. · · 2024 · cited 9× · PMID 38791942 · DOI 10.3390/cancers16101863
  4. Immunotherapy with anti-G<sub>D2</sub> monoclonal antibody in infants with high-risk neuroblastoma.
    Kushner BH, Modak S, Kramer K, Basu EM, et al · · 2023 · cited 8× · PMID 35913764 · DOI 10.1002/ijc.34233

Verify or expand the search:

Other recruiting trials for High-Risk Neuroblastoma

Currently open trials in the same condition.

Other Memorial Sloan Kettering Cancer Center trials

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing