Clinical Trial: Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I Clinical Trial of Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin

Brief Summary: The purpose of this Phase I study is to test the safety of different doses of specially prepared immune cells (called "T cells") collected from blood. The Investigators want to find a safe dose of these modified T cells for patients who have malignant pleural disease. They want to find out what effects these T cells have on the patient and the cancer (MPD).

Detailed Summary: This is an open-label, dose-escalating, non randomized, single-center, phase I study of mesothelin-targeted T cells administered intrapleurally as a single infusion in patients with a diagnosis (histologically or cytologically documented) of MPD from mesothelioma, lung cancer, or breast cancer. The total number of patients studied will depend on the number of dose levels tested, up to a maximum dose of 3×10^6 mesothelin-targeted T cells/kg or until the maximum tolerated dose (MTD) is reached.
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: Composite measure of severity and number of adverse events (AEs); changes in clinical laboratory test findings (hematologic and chemistry); and physical examination. [ Time Frame: 1 year ]

All AEs and laboratory toxicities will be graded using version 4 of the CTCAE.


Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in serum levels of the biomarker soluble mesothelin related peptide (SMRP) [ Time Frame: 60 days (+/-5 days) after treatment ]

Mesothelin is an immunogenic cell surface antigen, that is expressed at high levels in MPD and mesothelioma pleural fluid will be drained from the chest by thoracentesis or through a pleural catheter and will be preserved for analysis .


Original Secondary Outcome: Same as current

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: April 2, 2015
Date Started: May 2015
Date Completion: April 2018
Last Updated: April 6, 2017
Last Verified: April 2017