Protocol Details
A Phase 1 / 2 Single Arm Open-label Clinical Trial of Gavocabtagene Autoleucel (gavo-cel) in Patients with Advanced Mesothelin Expressing Cancer
This study is NOT currently recruiting participants.
Summary
Number |
19-C-0117 |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
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) |
None |
Intervention(s) |
Device: MSLN testing
Drug: fludarabine
Drug: ipilimumab
Drug: nivolumab
Device: cyclophosphamide
Biological/Vaccine: gavo-cel
|
Supporting Site |
National Cancer Institute |
Background:
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.
Eligibility
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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT03907852