Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma

Prior treatment

• Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
• Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
• Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.

Other illness

• Subjects with a history of chronic or acute hepatitis C or B infection.
• Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.
• Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors)

Other

• Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
• Subjects known to be pregnant or nursing.

• Subjects must understand and sign the study specific informed consent
• Subjects must be in primary remission
• Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks (by central read)
• Subjects must be HLA-A2 positive by central lab
• Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
  • Hemoglobin (Hgb) > 8 g/dL
  • Absolute Neutrophil Count (ANC) > 1000/mm3
  • Platelet count > 100,000/mm3
  • Blood Urea Nitrogen (BUN) < 30 mg/dL
  • Creatinine < 2 mg/dL
  • Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
  • Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x unless therapeutically warranted
• Subjects must use effective contraceptive methods during the study and for three months following the last dose of study product, if of reproductive age and still retain fertility potential.
• Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.