EGFRvIII CAR T Cells for Newly-Diagnosed WHO Grade IV Malignant Glioma (ExCeL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02664363|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2016
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Gliosarcoma||Biological: EGFRvIII CAR T cells||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EGFRvIII Chimeric Antigen Receptor (CAR) Gene-modified T Cells for Patients With Newly-Diagnosed GBM During Lymphopenia|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||September 25, 2018|
|Estimated Study Completion Date :||September 25, 2019|
Experimental: EGFRvIII CAR T cells
Dose escalation cohorts for 4 dose levels will be considered: #1: 4.5 x 10^6/kg, #2: 1.5 x 10^7/kg, #3: 4.5 x 10^7/kg, and #4: 1.5 x 10^8/kg. Starting at dose level 1, cohorts of 3-6 subjects will be accrued at each dose level.
Biological: EGFRvIII CAR T cells
The name of the drug is CAR gene-modified T cells or abbreviated as EGFRvIII CARs. The class of action is a biological and the mechanism of action is cytotoxicity. The drug substance is autologous T cells transduced with a retroviral vector encoding for a chimeric antigen receptor (CAR) directed against the tumor specific antigen, EGFRvIII. EGFRvIII CARs are genetically engineered T cells that have been taken from patients with GBM ex vivo to express a CAR recognizing the GBM tumor-specific antigen EGFRvIII, which is expressed on a subset of GBMs but not in normal human tissues with the aim of mediating regression of their tumors. Patients' CARs will be radiolabeled with 111In for correlative studies in the expanded cohort.
- MTD [ Time Frame: 12-18 months ]The primary objective is to determine the MTD of a single IV infusion of EGFRvIII CAR T cells in patients with newly-diagnosed GBM.
- DLT [ Time Frame: 12-18 months ]To determine the DLT of a single IV infusion EGFRvIII CAR T cells in patients with newly-diagnosed GBM.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664363
|United States, North Carolina|
|The Preston Robert Tisch Brain Tumor Center at Duke|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David Ashley, MBBS, FRACP, PhD||Duke University Hospital|
|Principal Investigator:||Daniel Landi, MD||Duke University|