Title: Phase I/II Study of Metastatic Cancer Using Lymphodepleting Conditioning Followed by Infusion of Anti-mesothelin Gene Engineered Lymphocytes1

Principal Investigator: Steven A Rosenberg, MD, National Cancer Institute (NCI)

Description: For this open-label, single-group assignment phase 1/2 study (ClinicalTrials.gov Identifier: NCT01583686), researchers are evaluating whether chimeric antigen receptor (CAR)-T cell immunotherapy that targets mesothelin is safe and effective among patients with metastatic, mesothelin-expressing tumors.

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Patients with mesothelioma or cervical, pancreatic, ovarian, or lung cancer will be enrolled to receive fludarabine, anti-mesothelin CAR-T cell therapy, cyclophosphamide, and aldesleukin. All patients will undergo leukapheresis prior to therapy; white blood cells will modified to target mesothelin.

The primary outcomes are safety and anti-tumor efficacy. The estimated number of enrolled patients is 136.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01583686.

Status: This study is open and recruiting patients as of April 27, 2018.

This study is sponsored by the NCI.


  1. Clinicaltrials.gov. CAR T cell receptor immunotherapy targeting mesothelin for patients with metastatic cancer. NCT01583686. https://clinicaltrials.gov/ct2/show/NCT01583686. Accessed April 27, 2018.