Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
Summary
This is an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) derived from a patient's primary brain tumor tissues. Young patients with embryonal central nervous system (CNS) malignancies typically are unable to receive irradiation due to significant adverse effects and are treated with intensive chemotherapy followed by autologous stem cell rescue; however, despite intensive therapy, many of these patients relapse. In this study, individualized TSA-T cells will be generated against proteogenomically determined tumor-specific antigens after standard of care treatment in children less than 5 years of age with embryonal brain tumors. Correlative biological studies will measure clinical anti-tumor, immunological and biomarker effects.
Timeline
- Start
- 2024-09-20
- Primary completion
- 2030-12-29
- Completion
- 2032-12-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TSA-T | Cell therapy | 1e+07 cells | Other |
| Subject | TSA-T | Cell therapy | 2.5e+07 cells | Other |
| Subject | TSA-T | Cell therapy | 5e+07 cells | Other |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Etoposide | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Thiotepa | Other / unclassified | — | — |
| Background | Vincristine | Small molecule | — | — |