Clinical trial · Interventional
A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients With Glioblastoma Multiforme (GBM) Following Resection and Chemoradiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an immunotherapy in which the patient's immune response will be stimulated to kill the tumor cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some of the patient's white blood cells (WBC) will be removed and cultured in a laboratory with purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been exposed to the tumor antigens will then be given back to the patient as a vaccine over several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune response to kill the remaining GBM tumor cells after surgery and chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICT-107 | Biological | — | UNRESOLVED |
| Placebo DC | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ICT-107
- description
- Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
- interventionNames
- Biological: ICT-107
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Autologous dendritic cells that have not been pulsed with antigens
- interventionNames
- Biological: Placebo DC
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- 2 -3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and not yet received chemoradiation. 2. ≥ 18 years of age 3. HLA-A1 or HLA-A2 positive 4. KPS score of ≥ 70% 5. Baseline hematologic studies and chemistry profiles must meet the following criteria: Hemoglobin (Hgb) \> 9.9 g/dL total granulocyte count \> than 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) \< 4x upper limit of normal (ULN) prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x control unless therapeutically warranted 6. Female patients of child-bearing potential must have negative serum pregnancy test 7. If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier) 8. Sufficient paraffin embedded tumor sample for analysis MGMT methylation status 9. Written informed consent, Release of Medical Records Form and Health Insurance Portability and Accountability Act (HIPAA) reviewed and signed by patient or legally authorized representatives Exclusion Criteria: 1. Recurrent disease 2. Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer 3. Presence of any other active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin) 4. Severe pulmonary, cardiac or other systemic disease 5. Congestive heart failure Class III or IV according to New York Heart Association (NYHA) 6. Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed 7. Known history of an autoimmune disorder 8. Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness 9. Breastfeeding 10. Received any other therapeutic investigational agent within 30 days of enrollment 11. Reduction of steroids (dexamethasone) to a maximum of 2 mg twice a day (BID) prior to the first administration of study vaccine
References
Publications (0)
Data not yet available