Phase I EGFR BATs in Newly Diagnosed Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2023-05-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma

NCT07343986

Glioblastoma (GBM)

RECRUITING PHASE1

A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

NCT02573324

Glioblastoma Gliosarcoma

COMPLETED PHASE3

EGFRBi-Armed Autologous T Cells in Treating Patients With Recurrent or Refractory Glioblastoma

NCT02521090

Adult Brain Glioblastoma Adult Gliosarcoma Recurrent Brain Neoplasm

WITHDRAWN PHASE1/PHASE2

Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)

NCT00379470

Recurrent Glioblastoma Multiforme

COMPLETED PHASE3

A Study to Evaluate the Safety, Tolerance and Initial Efficacy of EGFRvIII CAR-T on Glioblastoma

NCT05802693

Recurrent Glioblastoma

NOT_YET_RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma Glioblastoma Multiforme

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

EGFR BATs administered in combination with standard of care temozolomide and radiation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Main Study

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.

Group Type EXPERIMENTAL

EGFR BATs with TMZ following SOC RT/TMZ

Intervention Type DRUG

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.

Subcohort for MGMT unmethylated patients

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.

Group Type EXPERIMENTAL

Weekly EGFR BATs following SOC RT/TMZ

Intervention Type DRUG

Standard of care: 6 weeks of RT and TMZ Experimental: 8 weekly doses of EGFR BATs following SOC RT and TMZ

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EGFR BATs with TMZ 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.

Intervention Type DRUG

Weekly EGFR BATs following SOC RT/TMZ

Standard of care: 6 weeks of RT and TMZ Experimental: 8 weekly doses of EGFR BATs following SOC RT and TMZ

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Histologically-confirmed newly diagnosed intracranial GBM or gliosarcoma
2. Age ≥ 18 years.
3. Karnofsky Performance Status ≥ 60.
4. Be willing and able to provide written informed consent for the trial.
5. 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.
6. Females of childbearing potential, and males, must be willing to use an effective method of contraception
7. 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.
8. 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

Exclusion Criteria

1. 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.
2. Patients with evidence of leptomeningeal dissemination or subependymal spread on initial MRI.
3. Patients with extracranial metastases.
4. Known hypersensitivity to cetuximab or other EGFR antibody.
5. Alpha 1,3 Galactose IgE ("alpha gal") test result outside of the reference range (indicating likely hypersensitivity to cetuximab)
6. Evidence of active bleeding or bleeding diathesis.
7. 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).
8. 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).
9. Has received a live vaccine within 30 days of planned start of study therapy.
10. Has received any treatment for GBM besides surgery.
11. Females must not be breastfeeding.
12. 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.
13. A patient may be excluded if, in the opinion of the treating clinician, the patient is not capable of being compliant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No