A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (gavocel) in Patients with Advanced Mesothelin-Expressing Cancer
Study of Gavo-Cel Alone or in Combination with Nivolumab or Ipilimumab in Patients with Advanced Cancer
Sponsor: TCR2 Therapeutics, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAU2314
U.S. Govt. ID: NCT03907852
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This study involves research of an investigational therapy called gavo-cel. The purpose of this study is to test the safety and the efficacy (how well the drug works to treat your cancer) of gavo-cel, possibly in combination with one or two additional FDA-approved drugs called nivolumab and ipilimumab, to find out what effects, if any, it has on patients with lung cancer, mesothelioma (a tumor of the tissue that lines the lungs, stomach, heart, and other organs), ovarian cancer (cancer of the ovaries), or cholangiocarcinoma (bile duct cancer). Gavo-cel is an investigational therapy which means it has not been approved by regulatory authorities such as the U.S. Food & Drug Administration (FDA) for the treatment of people with your medical condition. Gavo-cel is currently not on the market (available for you to receive a prescription for and/or to buy) in any country. Nivolumab and ipilimumab, are both FDA-approved drugs for the treatment of people with certain types of cancer, however, the combination of gavo-cel with either one or both of these drugs has not been FDA-approved. Nivolumab and ipilimumab are being combined together with gavo-cel in some patients with mesothelioma to test if the combination may work better at fighting your cancer. If you are eligible for study treatment, the modified cells will be given to you using a needle directly inserted into your vein, which is called intravenous infusion. The T-cells are modified in a way that can allow them to identify and possibly kill your tumor cells. The modification is done by gene transfer (moving genetic material from one place to another) which results in a change of the genes in the T-cells taken from your body, so they behave differently. These modified cells are called gavo-cel, and they target a specific protein called mesothelin which can be found on cancer cells.
This study is closed
Ran Reshef, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Have you been diagnosed with advanced cancer? Yes No
Do you have adequate organ function? Yes No
Are you pregnant or trying to become pregnant? Yes No
You may be eligible for this study

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