Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody

Completed

Conditions studied: Ewing Family of Tumors, Melanoma, Neuroblastoma, Osteosarcoma

In brief

Hu14.18K322A is a monoclonal antibody developed at St. Jude Children's Research Hospital (SJCRH) that is made to bind to cancer cells that have a molecule called GD2 on their surface. Sometimes the human body will make an antibody to the therapeutic antibody (like hu14.18K322A) that is being given for treatment. These are called human anti-human antibodies (HAHA). When testing for HAHA in a previous cohort of patients who received hu14.18K322A, it was found that some patients tested positive for high levels of an antibody before receiving hu14.18K322A or any other anti-GD2 antibody. In this study, investigators would like to know more about the nature of this pretreatment antibody, how often is it present, and if in the laboratory it increases the killing of tumor cells. OBJECTIVES: * To determine whether pretreatment anti-therapeutic antibodies (PATA) represent antibodies reactive against an epitope (allotypic determinant) found on the anti-GD2 antibody hu14.18K322A * To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro

Key facts

Study ID

NCT02159443

Run by

St. Jude Children's Research Hospital

People needed

76

Starts

2014-07-15

Expected to finish

2020-04-24

Last updated by the study team

2020-11-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All participants who have or will receive treatment at SJCRH with hu14.18K322A.

You may not qualify if…

• Those not receiving treatment at SJCRH with hu14.18K322A.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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