2
Clinical Trials associated with TSA-T directed against proteogenomically determined personalized TSA(Children's National Research Institute)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.
Phase I REsearch on Multi-antigen T Cell Infusion Against Neuro-oncologic Disease
This Phase I dose-escalation trial is designed to determine the safety and feasibility of rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) in patients with newly diagnosed diffuse intrinsic pontine gliomas DIPGs (Group A) or recurrent, progressive, or refractory non-brainstem CNS malignancies (Group B).
Pediatric and adult patients who have high-risk CNS tumors known to typically have positivity for one or more Tumor Antigen Associated (TAA) (WT1, PRAME and/or Survivin) will be eligible. TAA-T will all be generated from patient peripheral blood mononuclear cells (PBMC).
Group A patients (DIPG): The first TAA-T dose will be infused any time 14 days or more after completion of radiotherapy.
Group B patients (other recurrent/progressive/refractory CNS tumors): The first TAA-T dose will be infused any time 14 days or more after completing most recent course of conventional (non-investigational) therapy for their disease AND after appropriate washout periods as detailed in eligibility criteria.
100 Clinical Results associated with TSA-T directed against proteogenomically determined personalized TSA(Children's National Research Institute)
100 Translational Medicine associated with TSA-T directed against proteogenomically determined personalized TSA(Children's National Research Institute)
100 Patents (Medical) associated with TSA-T directed against proteogenomically determined personalized TSA(Children's National Research Institute)
100 Deals associated with TSA-T directed against proteogenomically determined personalized TSA(Children's National Research Institute)