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NCT02159443 · ClinicalTrials.gov registry record
Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 76
- Enrollment target
NCT02159443: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT02159443 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 76 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02159443 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 76 participants
- Enrollment target
Study 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
Primary Outcome
Objective: To determine whether pretreatment anti-therapeutic antibodies (PATA) represent antibodies reactive against an epitope (allotypic determinant) found on the anti-GD2 antibody hu14.18K322A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2014-07-15 |
| Est. Completion | 2020-04-24 |
What the finished NCT02159443 record still lists
NCT02159443 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 76 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02159443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02159443 about?
NCT02159443 is a clinical study titled "Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody". 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 f...
What is the current status of trial NCT02159443?
This trial is currently completed. The enrollment target is 76 participants. The study started on 2014-07-15. Estimated completion is 2020-04-24.
Who is sponsoring clinical trial NCT02159443?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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