This is a double blind Phase III study where eligible subjects are randomized into two
treatment arms following the SOC primary treatment with chemoradiation: Arm 1 will receive
ICT-107 in combination with the standard of care, temozolomide (TMZ), Arm 2 will receive TMZ
with a blinded control. A 1:1 randomization will be employed, where ARM 1 will receive
ICT-107 and Arm 2 will receive placebo control. All subjects must be HLA-A2+. All subjects
must have glioblastoma tissue that has tumor assessment for MGMT methylation status prior to
randomization (for stratification). Subjects will have had tumor resection and magnetic
resonance imaging (MRI) prior to enrollment into the study. After signing of written
informed consent and any required privacy compliance forms and screening, enrolled subjects
will undergo large volume apheresis at the study site for collection of PBMCs. Apheresis
product will be sent to the manufacturing site where both active therapy (ICT-107) and
control will be prepared for each subject prior to randomization The study period consists
of 4 time periods; a 6-week Post-Surgery Standard of Care Treatment Phase where subjects
receive radiotherapy and TMZ; TMZ and radiation to be initiated no more than 8 weeks after
surgical resection of glioblastoma; a Rest Period of no more than 14 days where subjects are
reassessed for eligibility, and then randomized; a 4 week Induction Phase where study
therapy (ICT-107 or Control) is given weekly; followed by a Maintenance Phase where study
therapy is given monthly for 11 months, and then every 6 months until either progression,
withdrawal from the study, death, or the supply of autologous study therapy is exhausted.
Randomized subjects will receive 4 weekly administrations of subject-specific study therapy
(ICT-107 or Control) during the Induction Phase. No TMZ will be given during the 4 week
Induction Phase. Each study therapy injection will be delivered intradermally (axilla).
The Maintenance Phase will consist of administration of subject-specific study therapy
monthly for 11 months after the Induction Phase (for a total of 15 injections over 12 months
during the Induction and Maintenance Phases), and then every 6 mos. thereafter until
depletion or confirmation of progressive disease (PD). During the Maintenance Phase (where
ICT-107 or control are given monthly), the administration of TMZ and subject specific study
therapy or control will be separated in time by approximately 2 weeks (see Section 9.1.4).
Pre-treatment, treatment and assessment schedules will be the same for all subjects.
Inclusion Criteria:
1. Subjects must understand and sign the study specific informed consent
2. Subjects must be in primary remission
3. Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks as defined by
iRANO (by central read)
4. Subjects must be HLA-A2 positive by central lab
5. 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:
1. Hemoglobin (Hgb) > 8 g/dL
2. Absolute Neutrophil Count (ANC) > 1000/mm3
3. Platelet count > 100,000/mm3
4. Blood Urea Nitrogen (BUN) < 30 mg/dL
5. Creatinine < 2 mg/dL
6. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine
Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
7. Prothrombin Time (PT) and activated partial thromboplastin time (PTT) 1.6x
unless therapeutically warranted
6. 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.
7. Subjects must have at least one positive DTH skin response (more than 5 mm) to test
item challenge prior to randomization.
Exclusion Criteria:
1. Subjects receiving investigational study drug for any indication or
immunological-based treatment for any reason (Filgrastim may be used for prevention
of severe neutropenia).
2. Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
3. Subjects with concurrent conditions that would jeopardize the safety of the subject
or compliance with the protocol.
4. Subjects with a history of chronic or acute hepatitis C or B infection.
5. 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.
6. Subjects have any acute infection that requires specific therapy. Acute therapy must
have been completed within seven days prior to study enrollment.
7. Subjects with active malignancy diagnosed in the past 3 years (excepting in situ
tumors)
8. Subjects known to be pregnant or nursing.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
