This study is NOT currently recruiting participants.
Number
19-C-0117
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: No longer recruiting/follow-up only Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Fetuses;Adults who are or may become unable to consent;Pregnant Women;Children;Neonates
Keywords
Gene Therapy
Recruitment Keyword(s)
None
Condition(s)
Mesothelioma; Lung Neoplasms; Ovarian Neoplasms; Cholangiocarcinoma
Investigational Drug(s)
ipilimumab Fludarabine
Investigational Device(s)
Intervention(s)
Device: MSLN testing Drug: fludarabine Drug: ipilimumab Drug: nivolumab Device: cyclophosphamide Biological/Vaccine: gavo-cel
Supporting Site
National Cancer Institute
Mesothelin is a protein. Some cancer tumors express it in large amounts. This study is testing a therapy called Gavocabtagene autoleucel (gavo-cel, formerly TC-210 T cells). It is made from a person's own immune cells, called (T-cells). It attacks cells that carry this protein.
Objective:
To learn if gavo-cel is safe and what effects it has on people with mesothelin-expressing unresectable, metastatic, or recurrent cancers.
Eligibility:
Adults ages 18 and older with mesothelin-expressing unresectable, metastatic, or recurrent cancers
Design:
Participants will be screened with a tumor biopsy. A small piece of the tumor will be removed with a needle. If their tumor carries mesothelin, they will have blood and fluid tests, medical history, physical exam, performance tests, heart tests, and scans.
Participants will have leukapheresis. For this, T-cells are taken out from the blood. The rest of the blood is returned to the body. The T-cells are used to make gavo-cel. Participants may get drugs to prepare them to get the gavo-cel. They may need to stay in the hospital. About 5 weeks after leukapheresis participants will get 1 or 2 gavo-cel infusions.
Once the gavo-cel infusion is complete, participants will have visits:
Daily for the first 4 days
Every 3 days until day 10
Weekly until week 6
Every 2 weeks until week 12
Every 4 weeks until week 24
At the visits, participants will and repeat some of the screening tests. They will also give tissue samples for research.
After the first 24 weeks, participants will have visits every 3 months for up to 2 years. Then they will have yearly visits for 15 years.
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ELIGIBILITY CRITERIA: -Subjects greater than or equal to 18 years of age -Subject has a pathologically confirmed diagnosis (For pre-screening: fresh tissue preferred but banked tumor biopsy allowed if obtained within the prior 12 months. Note: cytology is insufficient) of either malignant pleural/peritoneal mesothelioma (MPM), serous ovarian adenocarcinoma, cholangiocarcinoma, or non-small cell lung cancer (NSCLC). -Subject must have mesothelin positive tumor (greater than or equal to 50% expression, 2+ to 3+) -Subject has at least 1 evaluable and measurable lesion as defined by RECIST v 1.1 -Subject must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease -Subjects must have an ECOG PS of 0 or 1. -Subjects must have adequate organ and bone marrow function -Subjects with active HIV, HBV, HCV or HTLV are not eligible -All subjects are required to undergo a fresh biopsy for mesothelin expression determination -A negative pregnancy test and appropriate contraception are required
-Subjects greater than or equal to 18 years of age
-Subject has a pathologically confirmed diagnosis (For pre-screening: fresh tissue preferred but banked tumor biopsy allowed if obtained within the prior 12 months. Note: cytology is insufficient) of either malignant pleural/peritoneal mesothelioma (MPM), serous ovarian adenocarcinoma, cholangiocarcinoma, or non-small cell lung cancer (NSCLC).
-Subject must have mesothelin positive tumor (greater than or equal to 50% expression, 2+ to 3+)
-Subject has at least 1 evaluable and measurable lesion as defined by RECIST v 1.1
-Subject must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease
-Subjects must have an ECOG PS of 0 or 1.
-Subjects must have adequate organ and bone marrow function
-Subjects with active HIV, HBV, HCV or HTLV are not eligible
-All subjects are required to undergo a fresh biopsy for mesothelin expression determination
-A negative pregnancy test and appropriate contraception are required
Principal Investigator
Referral Contact
For more information: