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CARv3-TEAM-E T Cells for Glioblastoma
Study Summary
This trial seeks to find the best dose of CARv3-TEAM-E T Cells to treat glioblastoma, a type of brain cancer.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cancer has returned for the first time and I've had radiation before.My cancer has returned or worsened for the first time and I've had radiation before.I have received treatments targeting EGFRvIII before.I've completed most of my radiation therapy without using temozolomide before getting CARv3-TEAM-E Infusion.I expect to take 4 mg or less of dexamethasone daily at the start of my CAR-v3-TEAM-E treatment.I am breastfeeding and receiving CARv3-TEAM-E treatment.I am willing and able to have an Ommaya reservoir placed.I am currently on long-term immune system suppressing drugs.I have not received any cancer treatment other than radiation.I am scheduled for radiation therapy without temozolomide.My brain tumor is located in the back part of my brain.I am using effective birth control methods during the trial.My tumor fits the specified size and location criteria.I have been cancer-free for over 5 years, except for certain noninvasive cancers.I can care for myself but may need occasional help.My GBM has recurred, lacks the EGFRvIII mutation but shows EGFR amplification.I am 18 years old or older.My side effects from previous cancer treatments have mostly gone away.I do not have any uncontrolled illnesses.I have chronic hepatitis B or active hepatitis C.I have recovered from side effects of previous cancer treatments, except for hair loss.My brain tumor has returned or shows specific genetic changes, including the EGFRvIII mutation.I haven't had alkylating therapy or immunotherapy in the last 4 weeks, and it's been long enough since my last investigational drug.I have not had gene therapy or gene-modified cell treatments.My blood counts and liver/kidney functions are within normal ranges.My newly diagnosed brain tumor has a specific EGFR mutation and lacks a certain chemical change in its DNA.My only cancer site is within my spinal cord.I have a tumor larger than 1 cm that can be measured with an MRI, not only in my spine or back of the brain.
- Group 1: Arm 2: Newly Diagnosed GBM, EGFRvIII Positive
- Group 2: Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive
- Group 3: Safety Run-In Phase
- 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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