drugset / Trial / NCT04211675
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1 study with Phase 2 expansion cohort. Phase 1 will assess the safety and tolerability of universal donor TGFβi NK Cell in combination with irinotecan, temozolomide, and dinituximab. The phase 2 of the study will estimate the response to treatment.
Timeline
- Start
- 2022-09-01
- Primary completion
- 2026-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | 17.5 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Subject | TROCULEUCEL | Cell therapy | 1e+08 cells/kg | — |
| Subject | Temozolomide | Small molecule | 3.3 mg/kg | Oral |
| Subject | Temozolomide | Small molecule | 100 mg/m2 | Oral |
| Subject | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |