Glioblastoma (GBM)Phase 1BATs FUSNCT07343986
Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma
A Phase 1 study testing anti-EGFR bispecific-armed T cells and Low-Intensity Focused Ultrasound in people with Glioblastoma (GBM), run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- anti-EGFR bispecific-armed T cells and Low-Intensity Focused Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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 for 1 month following completion of the EGFR BATs infusions.
- Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 10 days before leukapheresis.
Who cannot join
- 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, or any type of in situ cancer. Patients must not be on any treatment for another malignancy.
- 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.
Show all 27Show fewer
- 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 not in the best interest of the subject to participate, in the opinion of the treating investigator.
- A patient may be excluded if, in the opinion of the treating investigator, the patient is not capable of being compliant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Bettina Wagner, B.A., 434-243-7336, WXQ9ET@uvahealth.org
CJ Woodburn, B.S., CJW4V@uvahealth.org
About this study
Official title: Phase I Clinical Trial of Anti-CD3 × Anti-EGFR Bispecific-armed T Cells (EGFR BATs) and Low-Intensity Focused Ultrasound (LIFU) Blood-brain Barrier Opening in Patients With MGMT Unmethylated Glioblastoma (GBM)
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. The investigators will radiolabel the EGFR BATs with 89Zr-oxine for subsequent PET imaging to determine the trafficking and uptake of this approach. There is a concern that several infusions of EGFR BATs before BBB opening could change the immune tumor microenvironment that would not allow a permissive BBB after LIFU. Therefore, Arm A will have two LIFU with BBB opening after the 4th and the 8th infusion, and Arm B will have three LIFU with BBB opening after the 1st, 4th, and 8th infusions. This study will determine the safety and feasibility of the combination of low-intensity focused ultrasound (LIFU) with microbubbles BBB opening and EGFR BATs and the access of the adoptive cell immunotherapy to the tumor microenvironment to inform future studies.
- Conditions
- Glioblastoma (GBM)
- Being tested
- anti-EGFR bispecific-armed T cells, Low-Intensity Focused Ultrasound
- Keywords
- Focused Ultrasound, Unmethylated, Immune Therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-EGFR bispecific-armed T cellsDrug
Also called EGFR BATs
IN PROGRESS
Low-Intensity Focused UltrasoundDevice
Also called LIFU
Low-Intensity Focused Ultrasound will be used to open the blood-brain barrier
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Arm A will have Low-Intensity Focused Ultrasound (LIFU) after infusions 4 and 8. Receives: Drug: anti-EGFR bispecific-armed T cells; Device: Low-Intensity Focused Ultrasound |
| Arm B | Active comparator | Arm B will have Low-Intensity Focused Ultrasound (LIFU) after infusions 1, 4 and 8. Receives: Drug: anti-EGFR bispecific-armed T cells; Device: Low-Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of this treatment will be evaluated through the number of participants experiencing Grade ≥3 dose-limiting toxicities (DLTs).
The safety will be evaluated by determining the number of participants who experience Grade ≥3 DLTs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during EGFR BAT and LIFU BBB opening after RT/TMZ. The scale displays Grades 1 through 5 and refers to the severity of the AE. A higher grade (e.g., 5) represents a worse outcome.
Measured: 8 weeks
The feasibility of this treatment will be determined by the proportion of participants achieving ≥75% of the recommended EGFR BATs dose
The feasibility of this treatment will be determined by calculating the proportion of participants achieving ≥75% (60 x 10^9 EGFR BATs) of the recommended Phase II EGFR BAT dose.
Measured: 8 weeks
Incidence and severity of treatment-emergent adverse events (AEs) based on physical examination, vital signs, laboratory parameters, serum chemistry and hematology
Safety will be quantified using AE counts and severity grading per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Physical examinations, vital signs, and laboratory studies will be recorded.
Measured: 8 weeks
Brain uptake of 89Zr-oxine-labeled EGFR BATs measured by PET standardized uptake values (SUV) with and without LIFU BBB opening
Three PET imaging scans will be taken to quantify trafficking of labeled EGFR BATs into the GBM microenvironment. PET signal (SUV) will be compared across time points and between LIFU BBB-opened and non-opened regions.
Measured: 8 weeks
Secondary outcomes (12)
Change from baseline in peripheral immune response markers (CTL cytotoxicity)
Peripheral blood samples will be collected at baseline and at protocol-specified time points after treatment initiation. Immune response will be determined by CTL cytotoxicity. Changes from baseline will be summarized for each patient.
Measured: 8 weeks
Change from baseline in peripheral immune response markers (IFN-γ ELISpot Counts)
Peripheral blood samples will be collected at baseline and at protocol-specified time points after treatment initiation. Immune responses will be determined by IFN-γ ELISpot Counts (SFU). Changes from baseline will be summarized for each patient.
Measured: 8 weeks
Change from baseline in peripheral immune response markers (Th1/Th2 serum cytokine concentrations)
Peripheral blood samples will be collected at baseline and at protocol-specified time points after treatment initiation. Immune responses will be determined by Th1/Th2 serum cytokine concentrations. Changes from baseline will be summarized for each patient.
Measured: 8 weeks
PET-based quantification of 89Zr-oxine-labeled EGFR BAT trafficking across the BBB and into the GBM microenvironment after infusions and Low Intensity Focused Ultrasound (LIFU).
PET imaging will be used to measure radiotracer uptake (SUV) in the brain and tumor regions following infusions of 89Zr-labeled EGFR BATs. PET SUV after the 1st infusion's LIFU will be compared to the PET SUV after the 4th and the 8th infusion's LIFU.
Measured: 8 weeks
PET-based quantification of 89Zr-oxine-labeled EGFR BAT trafficking across the BBB and into the GBM microenvironment with versus without Low Intensity Focused Ultrasound (LIFU).
PET imaging will be used to measure radiotracer uptake (SUV) in the brain and tumor regions following infusions of 89Zr-labeled EGFR BATs. PET scans with and without LIFU BBB opening will be compared within patients and between study arms (Arm A vs Arm B). Specifically, PET SUV of patients who had LIFU after the infusion will be compared to patients who did not have LIFU after the infusion.
Measured: 8 weeks
Quantitative levels of circulating tumor DNA (ctDNA)
Peripheral blood will be collected before the 1st, 4th, and 8th EGFR BAT infusions and 1-2 hours after LIFU BBB opening. ctDNA concentration will be measured and expressed as absolute values and change from baseline.
Measured: 8 weeks
Quantitative levels of antibodies against tumor-associated antigens (IgG anti-EGFR and IgG anti-HER2)
Peripheral blood will be collected before the 1st, 4th, and 8th EGFR BAT infusions and 1-2 hours after LIFU BBB opening. The serum concentration of IgG anti-EGFR and IgG anti-HER2 will be measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: 8 weeks
Progression-free survival (PFS) measured using modified Response Assessment in Neuro-Oncology (RANO) criteria.
PFS will be defined as the time from surgery to the earliest date of confirmed radiographic or clinical progression determined by MRI and using modified RANO criteria. Progression will be determined by ≥25% increase in bidirectional product or ≥40% volumetric increase, development of new measurable disease, or clinical deterioration attributable to tumor. RANO scoring evaluates brain tumor response to treatment using MRI scans, categorizing the outcomes Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) based on changes in tumor size (measured by Sum of Perpendicular Diameters or volumetric methods).
Measured: From date of surgery to date of first documented progression, assessed up to 104 weeks.
Overall survival (OS)
OS will be defined as the time from surgery to death from any cause.
Measured: From date of surgery to date of documented death, assessed up to 104 weeks.
Correlation between immune response measures and clinical outcomes
Immune biomarkers (CTL cytotoxicity, IFN-γ ELISpot counts, Th1/Th2 cytokines, antibodies, ctDNA) will be correlated with clinical outcomes, including objective radiographic response (modified RANO), PFS, and OS. Associations will be evaluated using continuous and categorical analyses.
Measured: From baseline until 1-year post-treatment completion
Objective response rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) criteria
ORR will be calculated as the proportion of participants achieving confirmed complete response or partial response, defined by modified RANO volumetric or bidimensional thresholds. RANO scoring evaluates brain tumor response to treatment using MRI scans, categorizing the outcomes Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) based on changes in tumor size (measured by Sum of Perpendicular Diameters or volumetric methods).
Measured: From baseline until 1-year post-treatment completion
Incidence and severity of adverse events (AEs) and laboratory abnormalities
Safety will be assessed through physical examinations, vital signs, laboratory studies, serum chemistry and hematology. AEs will be graded using CTCAE v5.0. Counts and severity grades will be summarized over the treatment period.
Measured: From baseline through 30-days post-treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start23 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation, NaviFUS Corporation
- Responsible party
- Principal investigator, Camilo E. Fadul, MD, University of Virginia
- Investigators
- Camilo Fadul, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343986
- Sponsor's protocol ID
- HSR231550
- Acronym
- BATs FUS
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fadul CE, Thakur A, Kim J, Kassay-McAllister J, Schalk D, Lopes MB, Donahue J, Purow B, Dillon P, Le T, Schiff D, Liu Q, Lum LG. Phase I study targeting newly diagnosed grade 4 astrocytoma with bispecific antibody armed T cells (EGFR BATs) in combination with radiation and temozolomide. J Neurooncol. 2024 Jan;166(2):321-330. doi: 10.1007/s11060-024-04564-y. Epub 2024 Jan 23.
PubMed 38263486
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Anti-CD3 × Anti-EGFR Bispecific-armed T Cells (EGFR BATs) and Low-Intensity Focused Ultrasound (LIFU) Blood-brain Barrier Opening in Patients With MGMT Unmethylated Glioblastoma (GBM)
- ClinicalTrials.gov ID
- NCT07343986
- Acronym / sponsor ID
- BATs FUS / HSR231550
- Conditions
- Glioblastoma (GBM)
- Keywords
- Focused Ultrasound, Unmethylated, Immune Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation, NaviFUS Corporation
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The investigators will radiolabel the EGFR BATs with 89Zr-oxine for subsequent PET imaging to determine the trafficking and uptake of this approach. There is a concern that several infusions of EGFR BATs before BBB opening could change the immune tumor microenvironment that would not allow a permissive BBB after LIFU. Therefore, Arm A will have two LIFU with BBB opening after the 4th and the 8th infusion, and Arm B will have three LIFU with BBB opening after the 1st, 4th, and 8th infusions. This study will determine the safety and feasibility of the combination of low-intensity focused ultrasound (LIFU) with microbubbles BBB opening and EGFR BATs and the access of the adoptive cell immunotherapy to the tumor microenvironment to inform future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: anti-EGFR bispecific-armed T cells, Device: Low-Intensity Focused UltrasoundArm A will have Low-Intensity Focused Ultrasound (LIFU) after infusions 4 and 8. |
| Arm B | Active comparator | Drug: anti-EGFR bispecific-armed T cells, Device: Low-Intensity Focused UltrasoundArm B will have Low-Intensity Focused Ultrasound (LIFU) after infusions 1, 4 and 8. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (27 listed)
- 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, or any type of in situ cancer. Patients must not be on any treatment for another malignancy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-EGFR bispecific-armed T cellsAlso: EGFR BATsIN PROGRESS | Drug | Arm A, Arm B |
| Low-Intensity Focused UltrasoundAlso: LIFULow-Intensity Focused Ultrasound will be used to open the blood-brain barrier | Device | Arm A, Arm B |
Primary outcome
The safety of this treatment will be evaluated through the number of participants experiencing Grade ≥3 dose-limiting toxicities (DLTs).
Time frame: 8 weeks
The safety will be evaluated by determining the number of participants who experience Grade ≥3 DLTs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during EGFR BAT and LIFU BBB opening after RT/TMZ. The scale displays Grades 1 through 5 and refers to the severity of the AE. A higher grade (e.g., 5) represents a worse outcome.
The feasibility of this treatment will be determined by the proportion of participants achieving ≥75% of the recommended EGFR BATs dose
Time frame: 8 weeks
The feasibility of this treatment will be determined by calculating the proportion of participants achieving ≥75% (60 x 10^9 EGFR BATs) of the recommended Phase II EGFR BAT dose.
Incidence and severity of treatment-emergent adverse events (AEs) based on physical examination, vital signs, laboratory parameters, serum chemistry and hematology
Time frame: 8 weeks
Safety will be quantified using AE counts and severity grading per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Physical examinations, vital signs, and laboratory studies will be recorded.
Brain uptake of 89Zr-oxine-labeled EGFR BATs measured by PET standardized uptake values (SUV) with and without LIFU BBB opening
Time frame: 8 weeks
Three PET imaging scans will be taken to quantify trafficking of labeled EGFR BATs into the GBM microenvironment. PET signal (SUV) will be compared across time points and between LIFU BBB-opened and non-opened regions.
12 secondary outcomes
Change from baseline in peripheral immune response markers (CTL cytotoxicity)
Time frame: 8 weeks
Change from baseline in peripheral immune response markers (IFN-γ ELISpot Counts)
Time frame: 8 weeks
Change from baseline in peripheral immune response markers (Th1/Th2 serum cytokine concentrations)
Time frame: 8 weeks
PET-based quantification of 89Zr-oxine-labeled EGFR BAT trafficking across the BBB and into the GBM microenvironment after infusions and Low Intensity Focused Ultrasound (LIFU).
Time frame: 8 weeks
PET-based quantification of 89Zr-oxine-labeled EGFR BAT trafficking across the BBB and into the GBM microenvironment with versus without Low Intensity Focused Ultrasound (LIFU).
Time frame: 8 weeks
Quantitative levels of circulating tumor DNA (ctDNA)
Time frame: 8 weeks
Quantitative levels of antibodies against tumor-associated antigens (IgG anti-EGFR and IgG anti-HER2)
Time frame: 8 weeks
Progression-free survival (PFS) measured using modified Response Assessment in Neuro-Oncology (RANO) criteria.
Time frame: From date of surgery to date of first documented progression, assessed up to 104 weeks.
Overall survival (OS)
Time frame: From date of surgery to date of documented death, assessed up to 104 weeks.
Correlation between immune response measures and clinical outcomes
Time frame: From baseline until 1-year post-treatment completion
Objective response rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) criteria
Time frame: From baseline until 1-year post-treatment completion
Incidence and severity of adverse events (AEs) and laboratory abnormalities
Time frame: From baseline through 30-days post-treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 38263486Fadul CE, Thakur A, Kim J, Kassay-McAllister J, Schalk D, Lopes MB, Donahue J, Purow B, Dillon P, Le T, Schiff D, Liu Q, Lum LG. Phase I study targeting newly diagnosed grade 4 astrocytoma with bispecific antibody armed T cells (EGFR BATs) in combination with radiation and temozolomide. J Neurooncol. 2024 Jan;166(2):321-330. doi: 10.1007/s11060-024-04564-y. Epub 2024 Jan 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camilo Fadul, M.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anti-EGFR bispecific-armed T cells and Low-Intensity Focused Ultrasound in people with Glioblastoma (GBM), run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bettina Wagner, B.A. (434-243-7336, WXQ9ET@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of this treatment will be evaluated through the number of participants experiencing Grade ≥3 dose-limiting toxicities (DLTs). (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07343986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.