Study Title: Phase I/II Study of Autologous T Cells Engineered Using the Sleeping Beauty System to Express T-Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors
Status: open to enrollment (ClinicalTrials.gov Identifier: NCT05194735)
Objectives for part 1:
Arm A:
To define the incidence of DLT and the MTD of TCR-T cell drug product delivered as a single administration.
Arm B:
To determine the MTD/MAD/RP2D of TCR-T cell drug product delivered as a single administration followed by IL-2 administration.
In order to be enrolled in this trial, patients characteristics include: