NCIt definition : A preparation of autologous T-lymphocytes that have been genetically modified to co-express
three transgenes using the Sleeping Beauty (SB) transposon system and include a chimeric
antigen receptor (CAR) targeting an undisclosed tumor-associated antigen (TAA), a
membrane-bound IL-15 (mbIL15) and a safety/kill switch, with potential immunostimulating
and antineoplastic activities. Upon introduction of the autologous PRGN-3005 into
the patient, the T-cells target and bind to the TAA-expressing tumor cells, thereby
inducing selective toxicity in the TAA-expressing tumor cells. IL-15 is a pro-survival
cytokine that is required for the maintenance of long-lived CD8 memory T-cells and
use of mbIL15 preserves T stem-cell memory (TSCM) through sustained IL-15 signaling,
improves T-cell persistence and potentiates the immune response against tumor cells.
The safety switch can promote selective elimination of the CAR-T cells. The SB system
permits integration of the CAR, the IL-15 fusion variant and safety switch transgenes
into T-cells without the need for viral vectors and accelerates the manufacturing
process.;