Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed

Participants in this study will receive TSA-T after completion of standard-of-care treatment.

Patients will undergo surgical resection, then be treated with standard-of-care therapy as required, which may include up to 3 induction chemotherapy cycles (vincristine, cyclophosphamide, cisplatin, etoposide with or without methotrexate) and up to 3 consolidation cycles (carboplatin and thiotepa, each followed by an infusion of autologous peripheral blood stem cells).

TSA-T products will be manufactured at the cell therapy Good Manufacturing Practice (GMP) facility at Children's National Hospital (CNH). Patients enrolled in the study will receive their infusions at CNH.

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.

Live record on ClinicalTrials.gov →

• RECIPIENT SCREENING INCLUSION CRITERIA
• Diagnosis (select one group):
• Group A: New diagnosis of CNS embryonal tumors: medulloblastoma, embryonal tumor with multilayered rosettes, pineoblastoma, atypical teratoid/rhabdoid tumor, and embryonal tumor, not otherwise specified (NOS).
• Group B: Radiographic evidence consistent with recurrent ependymoma, with planned or recent re-resection.
• Group A: \<5 years of age at enrollment
• Group B: \>1 year and \<30 years of age at enrollment

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.