Title: Phase 1, adaptive-design trial of human chimeric antigen receptor modified T cells in patients with mesothelin expressing breast cancer

Principal Investigator: Julia Tchou, MD, PhD, of the University of Pennsylvania in Philadelphia

Description: Researchers are conducting a phase 1 trial to test the safety and feasibility of a chimeric antigen receptor (CAR) T-cell therapy in patients with mesothelin-expressing, advanced triple-negative breast cancer. 

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The therapy consists of autologous T cells transduced with a lentiviral vector expressing a CAR consisting of an anti-mesothelin M5 single chain variable fragment fused to the 4-1BB and CD3ζ signaling domains.

The trial has a sequential assignment model. Patients will receive either 3.00 x 107 or 3.00 x 106 CAR-T cells intratumorally. They will also undergo mesothelin expression testing.

The primary outcomes are the occurrence of treatment-limiting toxicities and the incidence of treatment-emergent adverse events. 

This trial was started with a single cohort, but the adaptive design will allow for additional diseases and other CAR T-cell therapies to be explored as separate cohorts under this protocol in the future.

To be eligible for this trial, patients must be 18 years of age or older. They must have locally advanced unresectable or metastatic triple-negative breast cancer with confirmed mesothelin expression. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This trial is sponsored by the University of Pennsylvania.


ClinicalTrials.gov. CAR T cells in mesothelin-expressing breast cancer. NCT05623488. Accessed March 17, 2023.