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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02159443
Enrollment
76
Registered
2014-06-10
Start date
2014-07-15
Completion date
2020-04-24
Last updated
2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ewing Family of Tumors, Melanoma, Neuroblastoma, Osteosarcoma

Keywords

Hu14.18K322A, Human anti-human antibodies (HAHA), Pretreatment anti-therapeutic antibodies (PATA)

Brief summary

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

Detailed description

In the proposed study, investigators will seek to determine the nature of this antibody that is being detected in the HAHA test for this group of patients, and if, in the laboratory, it increases the killing of tumor cells, accounting for the observation that some the patients who tested positive may have an improved outcome. The study will analyze DNA from blood samples of SJCRH patients treated with hu14.18K322A anti-GD2 antibody. Serological studies and confirmatory genotyping studies will be performed in a laboratory at the University of Wisconsin.

Interventions

None listed

Sponsors

University of Wisconsin, Madison
CollaboratorOTHER
St. Jude Children's Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Characterization of PATAOnce at participant enrollmentObjective: To determine whether pretreatment anti-therapeutic antibodies (PATA) represent antibodies reactive against an epitope (allotypic determinant) found on the anti-GD2 antibody hu14.18K322A
Number of samples with increased anti-tumor efficacyOnce, at enrollmentObjective: To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026