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Study Summary
This trial seeks to find the best dose of CARv3-TEAM-E T Cells to treat glioblastoma, a type of brain cancer.
- Glioblastoma
- Malignant Glioma
- Brain Tumor
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- You have received any gene therapy or treatment involving modified cells in the past.You have had allergic reactions to similar medicines like cetuximab.You are not currently taking any experimental medications.The location and size of your tumor must fit specific criteria outlined in section 3.1.7.You need to be able to have a special type of body scan called an MRI with a special dye.You are planning to receive radiation therapy without also taking temozolomide at the same time or afterwards.You have a type of brain tumor called recurrent GBM, but you do not have a specific gene mutation called EGFRvIII.You have a type of brain cancer called recurrent GBM with a specific mutation called EGFRvIII.You only have spinal disease and no other areas of the body affected.
- Group 1: Safety Run-In Phase
- Group 2: Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive
- Group 3: Arm 2: Newly Diagnosed GBM, EGFRvIII Positive
- Group 4: Arm 3: Recurrent GBM, EGFRvIII Negative
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What risks would participants in a Safety Run-In Phase be exposed to?
"As this is the first clinical trial of its kind, it was assigned a safety rating of 1. This reflects that there has been limited research into both the efficacy and security profile of Safety Run-In Phase."
Are there opportunities for volunteer participants in this research effort?
"According to clinicaltrials.gov, this medical research is no longer actively recruiting participants as it was last edited on December 13th 2022. Despite that fact, there are still 1,612 other studies seeking volunteers at the present time."
What key goals are being pursued with this research endeavor?
"This trial seeks to evaluate the number of Dose-Limiting Toxicities (DLTs) over two years. Secondary endpoints include Overall Response Rate, assessed using RANO Criteria; Overall Survival rate; and Progression Free Survival rates."
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