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

Paused · Phase 3 · Has a placebo group

Conditions studied: Glioblastoma Multiforme

In brief

ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.

Key facts

Study ID

NCT02546102

Run by

Precision Life Sciences Group

People needed

234

Starts

2024-12-01

Expected to finish

2025-12-01

Last updated by the study team

2024-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 glioblastoma mutated IDH by Immunohistochemistry (IHC)
• Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
• 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 have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
• Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors)
• Subjects known to be pregnant or nursing.

Where it is running

• Dignity Health - St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• City of Hope Cancer Center — Duarte, California, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• University of California Irvine Chao Family Cancer Center — Orange, California, United States
• Kaiser Permanente — Redwood City, California, United States
• Kaiser Permanente — Sacramento, California, United States
• John Wayne Cancer Institute — Santa Monica, California, United States
• Stanford Cancer Institute — Stanford, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Associated Neurologists of Southern Connecticut — Fairfield, Connecticut, United States
• Smilow Cancer Hospital — New Haven, Connecticut, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Delray Medical Center — Boca Raton, Florida, United States
• Boca Raton Regional Hospital Lynn Cancer Institute — Boca Raton, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Georgia Regents University — Augusta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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