A Phase 1 interventional study of EGFR BATs with TMZ following SOC RT/TMZ and Weekly EGFR BATs following SOC RT/TMZ in Glioblastoma and Glioblastoma Multiforme, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by University of Virginia · Phase 1, Interventional, and Treatment
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.
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.
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
i. Additional inclusion criteria for sub-cohort: MGMT unmethylated according to UVA pathology testing
Exclusion Criteria:
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).
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.
Drug: EGFR BATs with TMZ following SOC RT/TMZ
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.
Drug: Weekly EGFR BATs following SOC RT/TMZ
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.
Standard of care: 6 weeks of RT and TMZ Experimental: 8 weekly doses of EGFR BATs following SOC RT and TMZ
Maximum tolerated dose
Maximum tolerated dose will be based on number of dose limiting toxicities at each dose level
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
Immune measures in blood- cellular phenotype
Sequential monitoring of 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
Sequential monitoring of 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
Sequential monitoring of 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
Sequential monitoring of 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
Sequential monitoring of 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
Sequential monitoring of 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
Progression-free survival (PFS)
Time frame: Every 3 months following last study visit until death or study closure, expected within 5 years
Survival
Overall Survival (OS)
Time frame: Every 3 months following last study visit until death or study closure, expected within 5 years
Response Rate
Objective 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
Imaging (extent of resection) will be evaluated for correlation with PFS and OS.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Through 30 days following last dose of EGFR BATs
Plan to share: No
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University of Virginia