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Spots Global Cancer Trial Database for Autologous Redirected RNA Meso-CIR T Cells

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Trial Identification

Brief Title: Autologous Redirected RNA Meso-CIR T Cells

Official Title: Phase 1 Clinical Trial of Autologous Mesothelin Re-Directed T Cells Administered Intravenously in Patients With Progressive Malignant Pleural Mesothelioma

Study ID: NCT01355965

Interventions

Autologous T cells

Study Description

Brief Summary: To determine the safety and manufacturing feasibility of IV autologous chimeric immune receptor (CIR) T cells transfected with anti-mesothelin messenger RNA (mRNA) expressing a single chain antibody variable fragment linked to the intracellular CD 3 zeta T cell receptor domain and the 4-1BB costimulatory domain.

Detailed Description: The purpose of this study is to test the safety of infusing the study product CIR T cells. These T cells are made using T cells obtained through apheresis and introducing the T cells to a temporary gene which will cause them to start making a new type of antibody that will attach mesothelin (this antibody is found on the surface of the cancer cells). In theory, once the modified T cells attach to mesothelin, the cells will be activated to stimulate the subject's own immune system to attack the mesothelin cells. This type of modified cell is called a T cell transduced transfected with chimeric anti-mesothelin immunoreceptor. Subjects will be enrolled serially with all subjects receiving 1xe8 to 1x1e9 modified CIR T cells every other day for 3 infusions. Each patient will be observed for 9 days for toxicity assessment prior to receiving a second cycle of modified CIR T cells every other day for 3 infusions. The preceding subject must have completed the two-cycle regimen and been observed for toxicity through day 21 before the next subject can be enrolled.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Contact Details

Name: Andrew Haas, MD, PhD

Affiliation: Abramson Cancer Center at Penn Medicine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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