drugset / Trial / NCT02650648
Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma
NaSingle-groupOpen-labelTreatment
Summary
This is a phase I study. The purpose of this study is to see if it is safe and feasible to give the participant cyclophosphamide (a type of chemotherapy), natural killer (NK) cells, and an antibody called Hu3F8 as a treatment for neuroblastoma. NK cells are a type of white blood cell. Funding Source- FDA OOPD
Timeline
- Start
- 2016-01-05
- Primary completion
- 2025-07-28
- Completion
- 2025-07-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naxitamab | Monoclonal antibody | 1.68 mg/kg | — |
| Subject | TROCULEUCEL | Cell therapy | 9.9e+06 cells/kg | Intravenous |
| Subject | TROCULEUCEL | Cell therapy | 1.49e+07 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 1500 mg/m2 | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | 600000 iu | Subcutaneous |