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.
Who can participate
Age range1 Year ā 30 Years
SexALL
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Inclusion criteria
ā. Diagnosis (select one group):
ā. Age:
ā. Tissue:
ā. Non-pregnant:
ā. Karnofsky or Lansky score of ā„60%.
ā. Adequate organ function, defined below:
ā. The patient (if ā„18 years old), or the patient's parent(s)/legal guardian(s) (if the patient is a minor), is capable of providing informed consent.
ā. Patient deemed to be of sufficient size to undergo MNC apheresis for TSA-T generation (Groups A and B) and PBSC rescue (Group A only).
Exclusion criteria
ā. Patients with progressive disease based on most recent evaluation (for subsequent infusions).
ā. Patients with uncontrolled infections.
ā
What they're measuring
1
Grade ā„3 infusion-related adverse event
Timeframe: 42 days of the first TSA-T infusion
2
Grade ā„4 non-hematologic adverse event
Timeframe: 42 days of the first TSA-T infusion
3
Grade ā„3 pneumonitis, uveitis
Timeframe: 42 days of the first TSA-T infusion
4
Grade ā„3 toxicities that are attributed to TSA-T
Timeframe: 42 days of the first TSA-T infusion
5
Any unexpected toxicity of grade ā„3 attributed to the infusion of TSA-T