OptiDiff® Platform Workflow

GRIT Bio's proprietary OptiDiff® platform is designed to first generate large quantities of mature, potent T cells through feeder-free ex vivo hematopoietic stem cell differentiation followed by efficient T cell expansion. The platform produces therapeutic-grade, potent allogeneic TCR-T or CAR-T cells suitable for off-the-shelf cell therapy. It can be expanded to conventional T cells and other non-conventional T cells, making OptiDiff® a powerful engine for developing a wide range of innovative off-the-shelf cell therapy products.
In a typical OptiDiff® application, human umbilical cord blood-derived CD34+ hematopoietic stem cells are genetically modified through lentiviral transduction and/or CRISPR-based gene editing to introduce a TCR, CAR and/or optional modulatory elements. Following a proprietary and streamlined five-week ex vivo culture process, these modified stem cells differentiate into CAR-iNKT cells suitable for allogeneic use. The platform is robust, highly reproducible and strictly controlled throughout the entire process, generating approximately 1012–1013 cells from an initial input of 106 cord blood stem cells. Thousands of clinical doses can be manufactured in a single batch. The harvested iNKT cells are highly pure and can be directly cryopreserved as therapeutic cell products. For CAR-iNKT manufacturing, the cells produced by the platform contain no conventional T cells, thereby largely minimizing risks of graft-versus-host disease (GvHD).
Our CAR-iNKT Pipeline
Leveraging the OptiDiff® platform's capabilities, it has been applied to the engineering and manufacturing of GRIT Bio's first allogeneic cell product GT719, aiming to demonstrate clinical benefit for patients with high unmet medical needs.
GT719
GT719 is an innovative universal allogeneic CAR-iNKT cell therapy and the world’s first “stem-cell-derived,” off-the-shelf iNKT therapy. Originated from allogeneic hematopoietic stem cells, GT719 expresses an anti-CD19 chimeric antigen receptor, iTCR and IL-15. Its core design harnesses the unique biology of iNKT cells: the iTCR recognizes lipid antigens presented by CD1d, enabling allogeneic use without TCR knockout and avoiding graft-versus-host disease (GvHD). By combining NK, iTCR and CAR-mediated cytotoxic mechanisms, GT719 delivers multipronged anti-tumor activity. Powered by Grit Bio’s proprietary OptiDiff® platform, GT719 enables high-purity manufacturing at the trillion-cell scale and enrichment of memory-like iNKT cells, ensuring durable in vivo persistence, reducing treatment costs and improving patient access.
Indications
Hematologic malignancies and autoimmune diseases
Platform
OptiDiff®
GT719: Design & Mechanism of Action
GT719: Design & Mechanism of Action

“Off-the-Shelf” Allogeneic iNKT Cell Therapy Platform

