Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)

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.

NCT Number	NCT06193759
Lead Sponsor	Children's National Research Institute
Conditions	Medulloblastoma, Childhood, Atypical Teratoid/Rhabdoid Tumor of CNS, Embryonal Tumor With Multilayered Rosettes, Pineoblastoma, Embryonal Brain Tumor Not Otherwise Specified, Ependymoma
Enrollment	12 participants
Start Date	2024-09-20
Primary Completion	2030-12-29 (estimated)
Study Completion	2032-12-29 (estimated)
Updated on ClinicalTrials.gov	2026-06-17