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

Korábbi kezelés

• another concomitant life-threatening disease (not including glioblastoma multiforme)
• requirement for treatment with glucocorticoids to control brain swelling

Más betegség

• a second malignancy that is not in remission as determined by the clinical investigator. Exception: squamous or basal cell carcinoma of the skin.
• presence of active autoimmune disease that is currently being actively treated.
• psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.

Egyéb

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

• Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment)
• Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cell vaccines
• The attenuated autologous cancer cell product generated has satisfied the product release criteria as determined by the sponsor quality control department
• Medical history, physical examination and laboratory testing performed within approximately 7 days before enrollment revealing kidney and liver organ function within normal limits
• not currently receiving glucocorticoids and have been off glucocorticoids for at least 24 hours prior to vaccination as well as when they receive the T cell infusion.
• 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.