CAR T-cell therapy has recently emerged as a revolutionary and potentially curative therapy for patients with certain hematologic malignancies, including refractory cancers. In 2017, two CAR T-cell therapies were approved by the FDA for the treatment of relapsed / refractory B-cell precursor acute lymphoblastic leukemia (ALL) and relapsed / refractory diffuse large B-cell lymphoma (DLBCL). While most researchers and clinical investigators continue to focus on the development of autologous or donor-derived CAR T-cell therapies, we are developing CAR T-cell product candidates created from clonal master engineered iPSC lines as off-the-shelf cancer immunotherapies for the treatment of hematologic malignancies and solid tumors.
We are developing FT819, an investigational, off-the-shelf CAR T-cell immunotherapy derived from a clonal engineered master iPSC line with a novel 1XX CAR targeting CD19 inserted into the T-cell receptor alpha constant (TRAC) locus and edited for elimination of T-cell receptor (TCR) expression. In a stringent xenograft model of disseminated lymphoblastic leukemia, FT819 has demonstrated enhanced tumor clearance and control of leukemia as compared to primary CAR19 T cells.
2022 ASH Poster PresentationInterim Phase I Clinical Data of FT819-101, a Study of the First-Ever, Off-the-Shelf, iPSC-Derived TCR-Less CD19 CAR T-Cell Therapy for Patients with Relapsed/Refractory B-Cell Malignancies
FT819: Advanced B-Cell Malignancies
A Phase I Study of FT819 in Subjects With B-cell Malignancies (NHL, CLL, ALL)