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Cell Therapy for Mesothelioma
Study Summary
This trial is testing a new cell therapy that consists of T cells that have been genetically engineered to express a single-domain antibody that recognizes human Mesothelin. The T cells are fused to the CD3-epsilon subunit, which is incorporated into the endogenous T cell receptor (TCR) complex. The aim of the trial is to establish the recommended Phase 2 dose and to evaluate the efficacy of the therapy in patients with advanced mesothelin-expressing cancers.
Eligibility Criteria
Inclusion Criteria
You may 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.Trial Design
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Who is running the clinical trial?
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- I've had at least one standard treatment for my advanced cancer before considering gavo-cel, except if I have Cholangiocarcinoma.I am healthy enough for a procedure to collect white blood cells and have good veins for it.My heart pumps well and I don't have serious fluid around it.I am fully active or restricted in physically strenuous activity but can do light work.My organ functions are within the required range.I am 18 years old or older.I have been diagnosed with MPM, ovarian cancer, cholangiocarcinoma, or NSCLC.Your tumor has been reviewed by a central laboratory.
- Group 1: Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab
- Group 2: Lymphodepletion followed by gavo-cel plus nivolumab
- Group 3: Lymphodepletion followed by gavo-cel
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Are there any precedent studies which investigated the efficacy of gavo-cel?
"At present, 889 live studies are conducting research into gavo-cel with 161 of these in Phase 3. Philadelphia, Pennsylvania is one hub for this research; however there exist 28443 locations running trials on the drug."
What medical ailments does gavo-cel have proven efficacy for?
"Gavo-cel has been known to be an effective treatment option for a variety of conditions, including multiple sclerosis, mixed-cell type lymphoma, and acute myelocytic leukemia."
Is there an open enrollment period for this exploration?
"According to clinicaltrials.gov, this trial remains open and accepting participants; the study was first advertised on April 15th 2019 with the most recent update posted on May 24th 2022."
How many participants has this research study accrued?
"The trial sponsors, TCR2 Therapeutics, must recruit 175 eligible patients for the medical experiment. The primary sites of operation are National Cancer Institute in Bethesda and Sarah Cannon Research Institute in Nashville."
Are there various sites actively conducting this experiment within the state?
"This trial is scattered across the world, featuring 7 locations such as National Cancer Institute in Bethesda, Sarah Cannon Research Institute in Nashville and Princess Margaret Cancer Centre in Toronto."
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