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New treatment option for Glioblastoma (GBM)
Official title Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma
ClinicalTrials.gov ID: NCT07343986
What this study is testing
What is anti-EGFR bispecific-armed T cells?
anti-EGFR bispecific-armed T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma (gbm).
Also referred to as EGFR BATs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1 study for patients with newly diagnosed MGMT unmethylated IDH wild-type glioblastoma utilizing autologous activated T-cells armed with bispecific antibody (EGFR-BATs) that recognize the tumor. The investigators hypothesized that the combination of infusions of EGFR BATs and low-intensity focused ultrasound would induce blood-brain barrier opening and increase the permeability of the adoptive immunotherapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Newly diagnosed supratentorial glioblastoma or gliosarcoma IDH wildtype and MGMT unmethylated that express EGFR (score ≥ 1 by IHC)) and confirmed by...
- Age ≥ 18 and ≤ 70 years at the time of signing informed consent.
- Karnofsky Performance Status (KPS) ≥ 70.
- Be willing and able to provide written informed consent for the trial.
- Females of childbearing potential, and males, must be willing to use an effective method of contraception.
You likely can't join if
- Patients with a diagnosis of another malignancy within 2 years of being on-study. Exceptions include basal cell carcinoma of the skin, squamous cell...
- Patients undergoing only biopsy (partial resection or greater is required).
- Patients with cerebellar or brainstem tumors.
- Patients with evidence of leptomeningeal dissemination or subependymal spread on initial MRI.
- Patients with extracranial metastases.
- Patients with evidence of acute intracranial hemorrhage.
See the full eligibility criteria
- Newly diagnosed supratentorial glioblastoma or gliosarcoma IDH wildtype and MGMT unmethylated that express EGFR (score ≥ 1 by IHC)) and confirmed by UVA pathology review.
- Age ≥ 18 and ≤ 70 years at the time of signing informed consent.
- Karnofsky Performance Status (KPS) ≥ 70.
- Be willing and able to provide written informed consent for the trial.
- Females of childbearing potential, and males, must be willing to use an effective method of contraception.
- Maximal surgical debulking of the tumor was performed where residual contrast enhancement is 2 cm3 or less on immediate post-operative MRI. Intraoperative post-resection MRI is acceptable.
- Able to communicate during the LIFU BBB opening procedure.
- BBB opening target(s) must lie in non-eloquent area(s).
- The brain tumor to be treated must be in the treatment envelope of the NaviFUS system with a minimum distance of 30 mm from the inner skull table.
- Females of childbearing potential should have a negative serum pregnancy test. Males who are partners of females of childbearing potential must agree to use an acceptable method of contraception throughout the study and...
- Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 10 days before leukapheresis.
- Patients with a diagnosis of another malignancy within 2 years of being on-study. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy...
- Patients undergoing only biopsy (partial resection or greater is required).
- Patients with cerebellar or brainstem tumors.
- Patients with evidence of leptomeningeal dissemination or subependymal spread on initial MRI.
- Patients with extracranial metastases.
- Patients with evidence of acute intracranial hemorrhage.
- Known hypersensitivity to cetuximab or another EGFR antibody.
- Known sensitivity to gadolinium-based contrast agents.
- Known sensitivity to Lumason® ultrasound contrast agent.
- Alpha 1,3 Galactose IgE ("alpha gal") test result outside of the reference range (indicating likely hypersensitivity to cetuximab).
- Patients with claustrophobia.
- Clips, shunts, or other non-MRI compatible metallic implanted objects in the skull or the brain.
- Evidence of active bleeding or bleeding diathesis.
- Unable to discontinue use of anticoagulant therapy as per local standard.
- Scalp atrophy or scars in the expected location of the ultrasound transducer.
- Cardiac Status: Patients will be ineligible for treatment on this protocol if (before protocol entry):
- There is a history of a recent (within one year) myocardial infarction or stroke.
- There is a current or prior history of angina/coronary symptoms requiring medications and/or a history of depressed left ventricular function (LVEF \< 45%).
- Patient has a pacemaker.
- There is clinical evidence of congestive heart failure requiring medical management.
- Has Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days of leukapheresis.
- Has received any treatment for GBM besides surgery.
- Females must not be pregnant or breastfeeding.
- Ongoing immunosuppressive therapy except for corticosteroids
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is...
- A patient may be excluded if, in the opinion of the treating investigator, the patient is not capable of being compliant.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.