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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 | Eligibility | Citations | Contacts

Summary

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)

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.

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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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Raffit Hassan, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5330
10 CENTER DR
BETHESDA MD 20892
(240) 760-6232
rh276q@nih.gov

Cathy I. Wagner, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N230
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3159
cathy.wagner@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03907852

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