drugset / Trial / NCT05400603
Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed /Refractory Neuroblastoma or Refractory/ Relapsed Osteosarcoma
NaSequentialOpen-labelTreatment
Summary
The goal of this clinical trial is to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate in children with refractory or recurrent neuroblastoma or refractory/ relapsed osteosarcoma as well as to define the toxicities of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate
Timeline
- Start
- 2023-11-06
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ex-vivo expanded allogeneic γδT cells | Cell therapy | 3e+06 cells/kg | — |
| Subject | Ex-vivo expanded allogeneic γδT cells | Cell therapy | 1e+07 cells/kg | — |
| Subject | Ex-vivo expanded allogeneic γδT cells | Cell therapy | 3e+07 cells/kg | — |
| Background | Dinutuximab | Monoclonal antibody | 17.5 mg/m2 | — |
| Background | Irinotecan | Small molecule | 50 mg/m2 | — |
| Background | Temozolomide | Small molecule | 100 mg/m2 | — |
| Background | Zoledronate | Other / unclassified | 0.0125 mg/kg | — |