drugset / Trial / NCT04837547
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Phase 1
Recruiting
24 enrolled
University of Florida
Beat Childhood Cancer Research Consortium · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy (Total tumor mRNA-pulsed autologous Dendritic Cells (DCs) (TTRNA-DCs), Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) and Autologous G-CSF mobilized Hematopoietic Stem Cells (HSCs)).
Timeline
- Start
- 2021-09-20
- Primary completion
- 2027-09
- Completion
- 2032-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor-specific ex vivo expanded autologous lymphocyte transfer | Cell therapy | 3e+06 cells/kg | — |
| Subject | Tumor-specific ex vivo expanded autologous lymphocyte transfer | Cell therapy | 3e+07 cells/kg | — |
| Subject | Tumor-specific ex vivo expanded autologous lymphocyte transfer | Cell therapy | 3e+08 cells/kg | — |