drugset / Trial / NCT03721068

Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

NCT03721068 ↗

NaSingle-groupOpen-labelTreatment

Summary

The body has different ways of fighting infections and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are molecules that fight infections and protect your body from diseases caused by bacteria and toxic substances. Antibodies work by sticking to those bacteria or substances, which stops them from growing and causing bad effects. T cells are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been enough to cure most patients. This multicenter study is designed to combine both T cells and antibodies in order to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells (CAR) cells targeted against the disialoganglioside (GD2) antigen that express Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9), also known as iC9.GD2.CAR.IL-15 T cells.

Timeline

Start
2019-02-19
Primary completion
2030-05-19
Completion
2044-06-19

Drugs

EvaluationDrugModalityDoseRoute
Subject iC9.GD2.CAR.IL-15 T cells Cell therapy 0.25 cells/kg —
Subject iC9.GD2.CAR.IL-15 T cells Cell therapy 0.5 cells/kg —
Subject iC9.GD2.CAR.IL-15 T cells Cell therapy 1 cells/kg —
Subject iC9.GD2.CAR.IL-15 T cells Cell therapy 1.5 cells/kg —
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous