DNA vaccine trains immune system to fight brain cancer
NCT ID NCT05698199
First seen Jun 29, 2026 · Last updated Jul 02, 2026 · Updated 3 times
Summary
This early-stage trial tests a DNA vaccine called ITI-1001 in people with newly diagnosed glioblastoma, an aggressive brain cancer. The vaccine is designed to teach the immune system to recognize and attack cancer cells that carry common cytomegalovirus (CMV) proteins. About 10 participants who have had surgery and will receive standard chemoradiation will get the vaccine to see if it is safe and triggers an immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ITI-1001 (DNA vaccine targeting CMV antigens)
- What this could lead to
- If successful, this could point toward a new immunotherapy approach to help control glioblastoma by training the immune system to attack tumor cells.
- What could go wrong
- This is a very early, small phase I trial focused on safety, so it may not show clear benefit. The vaccine targets CMV proteins, which may not be present in all tumors, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Newly diagnosed patients with histopathological diagnosis of WHO grade IV glioma (GBM). 2. Age ≥ 18 years. 3. Patient must have undergone a gross/near-gross total surgical resection of tumor by analysis of residual enhancing tumor remnant on the immediate post-operative MRI (within 72 hours after surgery) as defined by ≤ 3 cm2 residual enhancing tumor longest perpendicular planes by MRI. 4. Planned standard adjuvant chemoradiation (SOC RT + TMZ for 6 weeks). 5. Karnofsky performance status ≥ 70. 6. Life expectancy ≥ 3 months. 7. All patients must be able to understand and be willing to sign written informed consent and aware of the investigational nature of the study. 8. Patient has adequate renal function (creatinine ≤ 1.5 times the upper limit of normal \[ULN\]) or a glomerular filtration rate (GFR) of ≥ 50 mL/min/1.73 m2). 9. Patient has adequate hepatic function, as evidenced by a total bilirubin ≤1.5 times the ULN, aspartate transaminase (AST), and /or alanine transaminase (ALT) ≤3 times the ULN. 10. Patient has adequate bone marrow function, as evidenced by hemoglobin ≥ 9.0 g/dL in the absence of transfusion within the 72 hours prior to the screening visit, platelet count ≥ 100×109cells/L, and absolute neutrophil count (ANC) ≥ 1.5×109 cells/L. 11. Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last investigational product dose, as follows: * For women: Negative pregnancy test during screening and at baseline and compliant with 2 methods of medically approved contraceptive regimens during and for 3 months after the treatment period or documented to be surgically sterile or postmenopausal. * For men: Compliant with 2 methods of medically approved contraceptive regimens during and for 3 months after the treatment period or documented to be surgically sterile. 12. Patient is willing to participate in the study and comply with all study requirements. Exclusion Criteria: 1. Participation in another therapeutic clinical trial. 2. Implantable electronic device. 3. Pregnant or breast feeding. 4. Tumor location or tumor primarily located in spinal cord or brain stem, multi-focal disease, or significant leptomeningeal disease. 5. Evidence of significantly increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness). 6. Known history of AIDS/HIV. Testing is not required. 7. Patient has a history of other malignancy treated with curative intent within the previous 3 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with previous invasive cancers are eligible if the treatment was completed more than 3 years prior to initiating current study treatment, and there is no evidence of recurrent disease. 8. Patient has an important medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study. 9. History of unstable cardiac arrhythmia or palpitations \[e.g., supraventricular tachycardia, atrial fibrillation, frequent ectopy, or sinus bradycardia (i.e., \<50 beats per minute on exam)\] prior to study entry. Sinus arrhythmia is not excluded. 10. Any chronic or active neurologic disorder that in the opinion of the Investigator would compromise the patient participation and/or integrity of the study. Patients with seizures due to recent onset of GBM that are medically controlled are eligible. 11. Syncopal episode within 12 months of screening. 12. Presence of any surgical or traumatic metal implants at the site of administration (medial deltoid or vastus lateralis muscles or overlying skin) or conditions incompatible with electroporation per instruction manual of the TriGrid TDS-IM V2. 13. Patients requiring dexamethasone within 7 days before first priming vaccination of ITI-1001. 14. Contraindication to IM injections or blood draws. 15. Less than 2 acceptable potential injection sites for IM injection and electroporation considering the left and right medial deltoid, and anterolateral quadriceps muscles. A site for injection and electroporation is not acceptable if there is inadequate muscle mass to support at least a 19 mm/0.75 inch injection depth or a skinfold thickness measurement of ≥50 mm/1.97 inch as assessed using the provided caliper. Eligible injection sites must also be free from tattoos, hypertrophic skin patches, keloids or other skin conditions which could interfere with the administration procedure or subsequent assessment of local reactogenicity. Note: To ensure adequate muscle mass for administrations, for participants with a weight ≤65 kg, potentially eligible administration sites are confined to the outer aspect of the upper thigh (left or right vastus lateralis muscle) (i.e,, the left and right medial deltoid are not eligible administration sites). 16. Any condition that, in the Investigator's opinion, would render the patient unable to comply with the study procedures and requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Other studies related to the condition(s) this trial covers.
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