drugset / Trial / NCT06450041
NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
Phase 2
Recruiting
62 enrolled
New Approaches to Neuroblastoma Therapy Consortium
Children's Neuroblastoma Cancer Fund · collabNationwide Children's Hospital · collabUnited Therapeutics · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.
Timeline
- Start
- 2024-12-16
- Primary completion
- 2028-12
- Completion
- 2038-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Universal Donor (UD) TGFβi NK Cells | Cell therapy | 1e+08 cells/kg | — |
| Background | Dinutuximab | Monoclonal antibody | 17.5 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Background | Temozolomide | Small molecule | 3.3 mg/kg | Other |
| Background | Temozolomide | Small molecule | 100 mg/m2 | Other |
| Background | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |