GlioblastomaPhase 1NCT03344250
Phase I EGFR BATs in Newly Diagnosed Glioblastoma
A Phase 1 study testing EGFR BATs with TMZ following SOC RT/TMZ and Weekly EGFR BATs following SOC RT/TMZ in people with Glioblastoma and Glioblastoma Multiforme, run by University of Virginia at 1 site in United States.
Trial summary
This is a phase I trial using EGFR Bi-armed Activated T-cells (BATs) in combination with standard of care temozolomide (TMZ) and radiation (RT) in patients with glioblastoma (GBM). The purpose of the study is to determine a safe dose of EGFR BATs when given with standard of care therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- EGFR BATs with TMZ following SOC RT/TMZ and Weekly EGFR BATs following SOC RT/TMZ
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 8 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed newly diagnosed intracranial GBM or gliosarcoma
- Age ≥ 18 years.
- Karnofsky Performance Status ≥ 60.
- Be willing and able to provide written informed consent for the trial.
- For patients with resection, CT/MRI with contrast must be performed within 72 hours following resection. Intraoperative post resection MRI is acceptable. No post surgery CT/MRI is required for patients who have received biopsy.
- Females of childbearing potential, and males, must be willing to use an effective method of contraception
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- Females of childbearing potential should have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Demonstrate adequate organ function as defined below. All screening labs should be performed within 10 days prior to apheresis.
- Absolute lymphocyte count ≥ 500/mm3, Absolute neutrophil count (ANC) ≥1,000 /mcL, Platelets ≥ 100,000 / mcL, Hemoglobin ≥ 9 g/dL (or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment), BUN ≤ 1.5 X upper limit of normal (ULN), Serum creatinine within the normal limits OR Measured or calculated creatinine clearance ≥60 mL/min/1.73m2, Serum total bilirubin ≤ 1.5 X ULN OR AST (SGOT) and ALT (SGPT) ≤ 5 X ULN, Albumin >2.5 mg/dL, International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN, unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Additional inclusion criteria for sub-cohort: MGMT unmethylated according to UVA pathology testing
Who cannot join
- Patients with a diagnosis of another malignancy within 3 years of being on-study. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Patients must not be on any treatment for another malignancy.
- Patients with evidence of leptomeningeal dissemination or subependymal spread on initial MRI.
- Patients with extracranial metastases.
- Known hypersensitivity to cetuximab or other EGFR antibody.
- Alpha 1,3 Galactose IgE ("alpha gal") test result outside of the reference range (indicating likely hypersensitivity to cetuximab)
- Evidence of active bleeding or bleeding diathesis.
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- Cardiac Status: Patients will be ineligible for treatment on this protocol if (prior to 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 evidence of depressed left ventricular function (LVEF < 45% by MUGA or ECHO).
- There is clinical evidence of congestive heart failure requiring medical management (irrespective of MUGA or ECHO results).
- 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 planned start of study therapy.
- Has received any treatment for GBM besides surgery.
- Females must not be breastfeeding.
- 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 clinician, the patient is not capable of being compliant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Targeting Newly Diagnosed Glioblastoma With Anti-CD3 × Anti-EGFR Bispecific Antibody Armed T Cells (EGFR BATs) in Combination With Radiation and Temozolomide
This is a phase I trial using EGFR Bi-armed Activated T-cells (BATs) in combination with standard of care temozolomide (TMZ) and radiation (RT) in patients with glioblastoma (GBM). The purpose of the study is to determine a safe dose of EGFR BATs when given with standard of care therapy.
Read the detailed description
In addition to finding the safe dose of EGFR BATs, immune evaluations will be performed as delineated in the schedule of events to measure immune responses during all stages of treatment for GBM.
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Being tested
- EGFR BATs with TMZ following SOC RT/TMZ, Weekly EGFR BATs following SOC RT/TMZ
- Keywords
- Adoptive Cell Therapy, Armed Activated T-cells, Bispecific Antibodies, Immunotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR BATs with TMZ following SOC RT/TMZDrug
Standard of care: 6 weeks of RT and TMZ and 6 cycles of TMZ (150-200 mg/m2) on days 1-5 of each 28 day cycle Experimental: EGFR BATs 2 and 3 weeks after completing RT, and then on day 21 of each cycle of TMZ.
Weekly EGFR BATs following SOC RT/TMZDrug
Standard of care: 6 weeks of RT and TMZ Experimental: 8 weekly doses of EGFR BATs following SOC RT and TMZ
| Study group | Role | What they receive |
|---|---|---|
| Main Study | Experimental | Study participants will have cells collected by leukapheresis prior to initiating standard concurrent RT and TMZ. Participants will receive the first and second infusions of EGFR BATs on days 14 and 21 after finishing concurrent RT and TMZ and then receive an infusion on day 21 of the first six cycles of TMZ. Receives: Drug: EGFR BATs with TMZ following SOC RT/TMZ |
| Subcohort for MGMT unmethylated patients | Experimental | Study participants will have cells collected by leukapheresis prior to initiating standard concurrent RT and TMZ. About 4 weeks after completion of RT/TMZ, participants will receive 8 weekly doses of EGFR BATs. Receives: Drug: Weekly EGFR BATs following SOC RT/TMZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Maximum tolerated dose will be based on number of dose limiting toxicities at each dose level
Measured: The study will not advance to the next dose until 7 days after the last patient in the cohort completes his or her second infusion of EGFR BATs
Secondary outcomes (14)
Immune measures in blood- cellular phenotype
Sequential monitoring of cellular phenotype
Measured: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- interferon-γ
Sequential monitoring of interferon-γ
Measured: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- EliSpots
Sequential monitoring of EliSpots
Measured: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- anti-GBM cytotoxicity of peripheral blood mononuclear cells directed at GBM cell lines
Sequential monitoring of anti-GBM cytotoxicity of peripheral blood mononuclear cells directed at GBM cell lines
Measured: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- serum cytokine patterns
Sequential monitoring of serum cytokine patterns
Measured: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- anti-GBM antibodies
Sequential monitoring of anti-GBM antibodies
Measured: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Clinical response
Progression-free survival (PFS)
Measured: Every 3 months following last study visit until death or study closure, expected within 5 years
Survival
Overall Survival (OS)
Measured: Every 3 months following last study visit until death or study closure, expected within 5 years
Response Rate
Objective Response Rate
Measured: Every 3 months following last study visit until death or study closure, expected within 5 years
Correlation of imaging to PFS and OS
Imaging (extent of resection) will be evaluated for correlation with PFS and OS.
Measured: Up to 12 months after study treatment completion
Correlation of pathology to PFS and OS
EGFR expression and tumor-infiltrating lymphocytes and age will be evaluated for correlation with PFS and OS.
Measured: Up to 12 months after study treatment completion
Correlation of clinical response to PFS and OS
Steroid use at the time of leukapheresis and age will be evaluated for correlation with PFS and OS.
Measured: Up to 12 months after study treatment completion
Correlation of immune response to PFS and OS
Immune response characteristics will be evaluated for correlation with PFS and OS.
Measured: Up to 12 months after study treatment completion
Adverse events, including dose limiting toxicities
Safety of 8 weekly doses of BATs in unmethylated MGMT patients without adjuvant temozolomide
Measured: Through 30 days following last dose of EGFR BATs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Mar 2018
- Primary completion8 Dec 2021
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies 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
- Single group
- Model description
- EGFR BATs administered in combination with standard of care temozolomide and radiation
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilo E. Fadul, MD, University of Virginia
- Investigators
- Camilo Fadul, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344250
- Sponsor's protocol ID
- 20105
- Status last verified
- Jan 2023
- First submitted
- 2 Nov 2017
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lum LG, Thakur A, Al-Kadhimi Z, Colvin GA, Cummings FJ, Legare RD, Dizon DS, Kouttab N, Maizel A, Colaiace W, Liu Q, Rathore R. Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial. Clin Cancer Res. 2015 May 15;21(10):2305-14. doi: 10.1158/1078-0432.CCR-14-2280. Epub 2015 Feb 16.
PubMed 25688159Vaishampayan U, Thakur A, Rathore R, Kouttab N, Lum LG. Phase I Study of Anti-CD3 x Anti-Her2 Bispecific Antibody in Metastatic Castrate Resistant Prostate Cancer Patients. Prostate Cancer. 2015;2015:285193. doi: 10.1155/2015/285193. Epub 2015 Feb 23.
PubMed 25802762Fadul 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Targeting Newly Diagnosed Glioblastoma With Anti-CD3 × Anti-EGFR Bispecific Antibody Armed T Cells (EGFR BATs) in Combination With Radiation and Temozolomide
- ClinicalTrials.gov ID
- NCT03344250
- Acronym / sponsor ID
- 20105
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Keywords
- Adoptive Cell Therapy, Armed Activated T-cells, Bispecific Antibodies, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 17 Nov 2017 (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 I trial using EGFR Bi-armed Activated T-cells (BATs) in combination with standard of care temozolomide (TMZ) and radiation (RT) in patients with glioblastoma (GBM). The purpose of the study is to determine a safe dose of EGFR BATs when given with standard of care therapy.
Detailed description
In addition to finding the safe dose of EGFR BATs, immune evaluations will be performed as delineated in the schedule of events to measure immune responses during all stages of treatment for GBM.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- EGFR BATs administered in combination with standard of care temozolomide and radiation
| Arm | Type | Receives |
|---|---|---|
| Main Study | Experimental | Drug: EGFR BATs with TMZ following SOC RT/TMZStudy participants will have cells collected by leukapheresis prior to initiating standard concurrent RT and TMZ. Participants will receive the first and second infusions of EGFR BATs on days 14 and 21 after finishing concurrent RT and TMZ and then receive an infusion on day 21 of the first six cycles of TMZ. |
| Subcohort for MGMT unmethylated patients | Experimental | Drug: Weekly EGFR BATs following SOC RT/TMZStudy participants will have cells collected by leukapheresis prior to initiating standard concurrent RT and TMZ. About 4 weeks after completion of RT/TMZ, participants will receive 8 weekly doses of EGFR BATs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically-confirmed newly diagnosed intracranial GBM or gliosarcoma
- Age ≥ 18 years.
- Karnofsky Performance Status ≥ 60.
- Be willing and able to provide written informed consent for the trial.
- For patients with resection, CT/MRI with contrast must be performed within 72 hours following resection. Intraoperative post resection MRI is acceptable. No post surgery CT/MRI is required for patients who have received biopsy.
Key exclusion criteria (16 listed)
- Patients with a diagnosis of another malignancy within 3 years of being on-study. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Patients must not be on any treatment for another malignancy.
- Patients with evidence of leptomeningeal dissemination or subependymal spread on initial MRI.
- Patients with extracranial metastases.
- Known hypersensitivity to cetuximab or other EGFR antibody.
- Alpha 1,3 Galactose IgE ("alpha gal") test result outside of the reference range (indicating likely hypersensitivity to cetuximab)
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 |
|---|---|---|
| EGFR BATs with TMZ following SOC RT/TMZStandard of care: 6 weeks of RT and TMZ and 6 cycles of TMZ (150-200 mg/m2) on days 1-5 of each 28 day cycle Experimental: EGFR BATs 2 and 3 weeks after completing RT, and then on day 21 of each cycle of TMZ. | Drug | Main Study |
| Weekly EGFR BATs following SOC RT/TMZStandard of care: 6 weeks of RT and TMZ Experimental: 8 weekly doses of EGFR BATs following SOC RT and TMZ | Drug | Subcohort for MGMT unmethylated patients |
Primary outcome
Maximum tolerated dose
Time frame: The study will not advance to the next dose until 7 days after the last patient in the cohort completes his or her second infusion of EGFR BATs
Maximum tolerated dose will be based on number of dose limiting toxicities at each dose level
14 secondary outcomes
Immune measures in blood- cellular phenotype
Time frame: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- interferon-γ
Time frame: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- EliSpots
Time frame: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- anti-GBM cytotoxicity of peripheral blood mononuclear cells directed at GBM cell lines
Time frame: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- serum cytokine patterns
Time frame: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Immune measures in blood- anti-GBM antibodies
Time frame: Before surgery (optional), during screening, at apheresis, at multiple timepoints during study treatment, following completion of study treatment, and every 2-6 months after completion of EGFR BATs infusions through 1 year after last EGFR BATs infusion
Clinical response
Time frame: Every 3 months following last study visit until death or study closure, expected within 5 years
Survival
Time frame: Every 3 months following last study visit until death or study closure, expected within 5 years
Response Rate
Time frame: Every 3 months following last study visit until death or study closure, expected within 5 years
Correlation of imaging to PFS and OS
Time frame: Up to 12 months after study treatment completion
Correlation of pathology to PFS and OS
Time frame: Up to 12 months after study treatment completion
Correlation of clinical response to PFS and OS
Time frame: Up to 12 months after study treatment completion
Correlation of immune response to PFS and OS
Time frame: Up to 12 months after study treatment completion
Adverse events, including dose limiting toxicities
Time frame: Through 30 days following last dose of EGFR BATs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 25688159Lum LG, Thakur A, Al-Kadhimi Z, Colvin GA, Cummings FJ, Legare RD, Dizon DS, Kouttab N, Maizel A, Colaiace W, Liu Q, Rathore R. Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial. Clin Cancer Res. 2015 May 15;21(10):2305-14. doi: 10.1158/1078-0432.CCR-14-2280. Epub 2015 Feb 16.
- Background: PubMed 25802762Vaishampayan U, Thakur A, Rathore R, Kouttab N, Lum LG. Phase I Study of Anti-CD3 x Anti-Her2 Bispecific Antibody in Metastatic Castrate Resistant Prostate Cancer Patients. Prostate Cancer. 2015;2015:285193. doi: 10.1155/2015/285193. Epub 2015 Feb 23.
- Derived from this study: 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. This study is not recruiting at the moment.
Camilo Fadul, MD 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 EGFR BATs with TMZ following SOC RT/TMZ and Weekly EGFR BATs following SOC RT/TMZ in people with Glioblastoma and Glioblastoma Multiforme, 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 10 inclusion and 16 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: finished, as of the sponsor's last update on 6 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: The study will not advance to the next dose until 7 days after the last patient in the cohort completes his or her second infusion of EGFR BATs). 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 NCT03344250, which also lists 3 linked publications.
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 Mar 2025.