Phase I Study of Mesothelin-Targeted CAR-T Cell Immunotherapy for Advanced Pancreatic and Other Cancers

What this Trial Is About

Researchers are conducting a phase I clinical trial to evaluate the safety, tolerance, and initial effectiveness of a new immunotherapy using second-generation CAR-T cells targeting Mesothelin, a protein found in advanced pancreatic cancer and other cancers. This study aims to test these CAR-T cells, which also secrete a fusion protein involving IL21 and scfv against PD1, to better understand their anti-cancer potential in patients whose tumors express Mesothelin. The treatment involves collecting blood from eligible patients to isolate and activate their T cells, which are then modified with the Mesothelin-targeting CAR and expanded. These CAR-T cells are infused back into the patients either systemically or locally. To improve the cancer-killing effect, some patients may also receive antibodies targeting PD1, PDL1, or CTLA4 alongside the CAR-T therapy. Biopsies and tests confirm Mesothelin expression before treatment. Participants are closely monitored after receiving the CAR-T cells, with evaluations including biopsy tests, blood analysis, and assessments of treatment response. The main measure is the number of patients experiencing dose-limiting toxicities within six months. Additional outcomes include the percentage of patients achieving complete or partial remission and the persistence of CAR-T cells over six years. The study lasts several years to track safety and efficacy.

Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers