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Protocol Details

A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients with Advanced Mesothelin-Expressing Cancer

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000954-C

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)

Neonates;
Fetuses;
Children;
Pregnant Women

Keywords

Gene Therapy;
Cart Cell Therapy;
CAR-T Cell Therapy

Recruitment Keyword(s)

None

Condition(s)

Pancreatic Neoplasms;
Ovarian Neoplasms;
Mesothelioma;
Colorectal Neoplasms;
Cholangiocarcinoma;
Carcinoma, Non-Small-Cell Lung

Investigational Drug(s)

Fludarabine
Cyclophosphamide

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: TC-510
Drug: Fludarabine
Drug: Cyclophosphamide
Diagnostic Test: MSLN Expression Testing
Drug: bendamustine
Drug: oxaliplatin

Supporting Site

National Cancer Institute

Background:

Cells in certain types of cancers produce high levels of a protein called mesothelin (MSLN). These cancers include mesothelioma and certain tumors of the pancreas, breast, ovaries, colon, and lungs. We are testing whether treatments that target MSLN can shrink the tumors and help patients live longer.

Objective:

To test a new treatment (TC-510) in people with cancers that express MSLN.

Eligibility:

People aged 18 years or older with a form of cancer that expresses MSLN.

Design:

Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will have imaging scans of their tumors. A new biopsy may be needed if a recent one is not available.

Participants will have up to 14 tablespoons of blood drawn. TC-510 is treatment created from a person s own immune cells. The cells are collected from the blood. Then they are genetically modified in a laboratory and returned to the body.

Participants will be screened again to see if they are eligible for treatment with TC-510. In addition to the previous tests, they will have tests of their heart function. They may fill out a questionnaire. They will answer questions about their quality of life.

Participants will receive chemotherapy every day for 4 days starting 1 week before treatment with TC-510.

TC-510 is given through a needle inserted into a vein. Some participants will receive 1 infusion. Others will have a second infusion 3 to 7 days after the first. Participants may need to stay in the hospital overnight after each infusion.

Follow-up visits for this study will continue for 2 years. Additional follow-up will continue for 15 years from time of treatment.

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Eligibility

INCLUSION CRITERIA:

-Patient is > 18 years of age at the time the Informed Consent is signed.

-Patient has a pathologically confirmed diagnosis of either MPM, Serous Ovarian Adenocarcinoma, Pancreatic Adenocarcinoma, TNBC, and Colorectal Cancer

-Patient's tumor has been reviewed with confirmed positive MSLN expression on >/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry.

-Prior to TC-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol

-Patients has an ECOG performance status 0 or 1

-Patient is fit for leukapheresis and has adequate venous access for the cell collection.

-Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol

EXCLUSION CRITERIA:

-Inability to follow the procedures of the study

-Known or suspected non-compliance, drug, or alcohol use


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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

Maria Garcia G. Agra, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D44
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3152
mariagracia.agra@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:

NCT05451849

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