Clinical trial · Interventional
EGFRBi-Armed Autologous T Cells in Treating Patients With Recurrent or Refractory Glioblastoma
Targeting Recurrent Glioblastoma With Anti-CD3 x Anti-EGFR Bispecific Antibody Armed T Cells: A Phase I/II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to lack of funding and a primary co-investigator of the trial leaving the institution.
Summary
Brief summary (as posted)
This phase I/II trial studies the side effects and best dose of epidermal growth factor receptor bispecific antibody (EGFRBi)-armed autologous T cells and how well it works in treating patients with glioblastoma that have come back or does not respond to treatment. EGFRBi-armed autologous T cells coated with antibodies (proteins used by the immune system to target and kill foreign objects such as cancer cells) may have great ability to seek out, attach to, and destroy glioblastoma cells.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Brain Glioblastoma | Adult Brain Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Brain Neoplasm | Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGFRBi-Armed Autologous T Cells | Biological | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (EGFRBi-armed autologous T cells)
- description
- PHASE I: Patients receive EGFRBi-armed autologous T cells IT twice weekly for 4 weeks. PHASE II: Patients receive EGFRBi-armed autologous T cells\* IT twice weekly for 4 weeks and then IV over 15-30 minutes twice weekly for 2 weeks. \*NOTE: Six selected patients receive EGFRBi-armed autologous T cells IV on day -3, -2, or -1 prior to first IT infusion.
- interventionNames
- Biological: EGFRBi-Armed Autologous T Cells
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Incidence of toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
- timeFrame
- Up to 7 days after the last infusion
- measure
- Overall survival (OS) (Phase II)
- timeFrame
- From study enrollment to death due to any cause, assessed up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed intracranial glioblastoma or gliosarcoma (World Health Organization \[WHO\] grade IV) with evidence of clinical and radiographic (computed tomography \[CT\] or MRI brain) tumor progression (need not be biopsy proven) * Patients who have undergone prior resection, radiation therapy, and/or chemotherapy (except bevacizumab) * Karnofsky performance score \>= 70 or Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1 * Patient agrees to undergo a baseline and a follow-up 11C-alpha-methyl-L-tryptophan (AMT)-PET scan during immunotherapy (IMT) * No serious medical or psychiatric illness which prevents informed consent or intensive treatment is allowed * Non pregnant: negative serum test for pregnancy, unless male, prior hysterectomy, tubal ligation, or postmenopausal; (Note: postmenopausal is defined as age \> 55 with amenorrhea for \> 1 year or age \< 55 years with amenorrhea for 2 years and follicle stimulating hormone (FSH) level within postmenopausal range of institutional parameters; patients requiring FSH level to determine menopausal status need not have this performed and may choose to proceed with serum pregnancy testing) * Required initial laboratory data (normal limits per treating institution; minor changes from the indicated laboratory guidelines will be allowed at the discretion of the treating team under special circumstances and reasons for the changes will be documented): * Granulocytes \>= 1,000/mm\^3 * Absolute lymphocyte count \>= 500/mm\^3 * Platelet count \>= 50,000/ul * Hemoglobin \>= 8 gm/dl * Blood urea nitrogen (BUN) =\< 1.5 times normal * Serum creatinine \< 1.8 mg/dl * Creatinine clearance \>= 50 ml/mm (can be calculated utilizing the Cockcroft \& Gault equation) * Bilirubin \< 1.5 times upper limit of normal * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 times upper limit of normal * Alkaline phosphatase \< 5 times upper limit of normal * Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) \< 1.2 times upper limit of normal * Negative human immunodeficiency virus (HIV)-1/2 serology * Negative hepatitis B surface antigen * Negative hepatitis C serology * Left ventricular ejection fraction (LVEF) \>= 45% at rest (multi gated acquisition \[MUGA\] or echocardiogram \[ECHO\]) * Each patient must be aware of the nature of their disease and must willingly consent to treatment after being informed of alternatives, potential benefits, side effects, and risks * Surgery is done prior to IMT if needed for palliation, tumor debulking, pathological documentation of tumor recurrence; the patients may continue on study therapy even if they do not have measurable disease * No other investigational agents, immunomodulating agents, or cancer chemotherapy are permitted for the duration and 12 months following the study IMT unless there is disease progression; radiotherapy is not permitted; appropriate antibiotics, blood products, antiemetics, fluids, electrolytes and general supportive care are to be used as necessary Exclusion Criteria: * Resective surgery within 2 months prior to the initial pre-treatment AMT-PET scan * Severe increased intracranial pressure, status epilepticus, or other serious complications from the brain tumor, requiring emergency or urgent intervention * Patients with a history of another malignancy within 5 years of study enrollment * Patients with extracranial metastases * Evidence of active bleeding or bleeding diathesis * 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 * 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)
References
Publications (0)
Data not yet available