drugset / Trial / NCT02465983

Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer

NCT02465983

NaSingle-groupOpen-labelTreatment

Summary

This is a study in which pancreatic cancer patients receive a combination therapy with CART-meso cells and CART19 cells administered at 3 days after one dose of cyclophosphamide. CART-meso cells are patients' own T cells that were modified in the laboratory to express a receptor specific to the mesothelin protein. CART19 cells are patients' own T cells that were modified in the laboratory to express a receptor specific to a protein called CD19. The CD19 protein is expressed on white blood B cells. CART19 cells are expected to attack the B cells and impede the antibody response against CART-meso cells. The investigators hypothesize that this combination therapy may prolong the duration of CART-meso cells in the body. Additionally, one dose of cyclophosphamide may enhance engraftment and persistence of CART cells.

Timeline

Start
2015-05
Primary completion
2017-09
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Subject CART-meso Cell therapy 1e+07 cells Intravenous
Subject CART-meso Cell therapy 1e+08 cells Intravenous
Subject Tisagenlecleucel Cell therapy 1e+07 cells Intravenous
Subject Tisagenlecleucel Cell therapy 1e+08 cells Intravenous
Background Cyclophosphamide Other / unclassified 1.5 g