Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)

Inclusion Criteria:

• Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment)

• Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cellvaccines

• The attenuated autologous cancer cell product generated has satisfied the productrelease criteria as determined by the sponsor quality control department

• Medical history, physical examination and laboratory testing performed withinapproximately 7 days before enrollment revealing kidney and liver organ functionwithin normal limits

• not currently receiving glucocorticoids and have been off glucocorticoids for atleast 24 hours prior to vaccination as well as when they receive the T cellinfusion.

• Patient function assessment (Karnofsky score is > 60)

• a life expectancy of > 12 weeks.

• Hemoglobin is > 10 g/dL (may be transfused)

• White blood cell count is > 3,000 cells/microliter (mcL) of blood.

• Platelet count is > 100,000 platelets per mcL of blood (transfusion independent)

• Lymphocyte count is > 1,000 cells/mcL of blood.

Exclusion Criteria:

• another concomitant life-threatening disease (not including glioblastoma multiforme)

• a second malignancy that is not in remission as determined by the clinicalinvestigator. Exception: squamous or basal cell carcinoma of the skin.

• requirement for treatment with glucocorticoids to control brain swelling

• presence of active autoimmune disease that is currently being actively treated.

• psychological, familial, sociological or geographical conditions that do not permitadequate medical follow-up and compliance with the study protocol.

• Current pregnancy or a plan to become pregnant within 1-year following the study.