Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
Trial Parameters
Brief 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.
Eligibility Criteria
RECIPIENT SCREENING INCLUSION CRITERIA 1. 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. 2. Age: o Group A: \<5 years of age at enrollment o Group B: \>1 year and \<30 years of age at enrollment 3. Tissue: * Group A: Availability of sufficient fresh or frozen tumor tissue (approximately 50 mg). * Group B: Expectation of sufficient fresh or frozen tumor tissue, in the opinion of study PI or sub-I (based upon radiographic evidence of disease). 4. Non-pregnant: * Group A: N/A * Group B: For female of childbearing potential, must have negative pregnancy test. Common to both groups: 5. Karnofsky or Lansky score of ≥60%. 6. Adequate organ function, defined below: i. ANC ≥750/µL. ii. Absolute ly