Activated T Cells Armed With GD2 Bispecific Antibody in Children and Young Adults With Neuroblastoma and Osteosarcoma
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Disseminated Neuroblastoma, Recurrent Neuroblastoma
In brief
Previous research has demonstrated that investigators can coat (arm) T cells with a special molecule called GD2 bispecific antibody that will help T cells recognize neuroblastoma and osteosarcoma cells and kill them. This bispecific antibody recognizes GD2, a protein found on almost all neuroblastoma and osteosarcoma cells. The investigators put the GD2 bispecific antibody on T cells and give large numbers of these T cells back to patients. The investigators think that these T cells may have a better chance of killing GD2 expressing tumor cells when they are armed with GD2 bispecific antibody. This trial studies the side effects and best dose of activated T cells armed with GD2 bispecific antibody and how well they work in treating patients with neuroblastoma, osteosarcoma, and other GD2-positive solid tumors.
Key facts
- Study ID
- NCT02173093
- Run by
- University of Virginia
- People needed
- 40
- Starts
- 2014-11-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2019-01-29
Who can join
Age: 1 and older, up to 29. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are postmenarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy and for 3 months after the last dose of GD2Bi-aATC; breastfeeding women should be excluded
- Patients who have an uncontrolled infection are not eligible
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Where it is running
- Children's Hospital of Michigan — Detroit, Michigan, United States (enrolling)
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States (enrolling)
- University of Virginia, Department of Pediatrics, Hematology/Oncology — Charlottesville, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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