SAN DIEGO, July 6, 2026
Fate Therapeutics announced that preliminary clinical data from its investigational FT819 off-the-shelf CD19-targeting CAR T-cell therapy will be presented during the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting. The presentation will feature findings from the systemic sclerosis (SSc) cohort of the company’s ongoing Phase 1 basket study evaluating FT819 across multiple autoimmune diseases. The trial is enrolling patients with treatment-refractory disease, including individuals with up to 15 years of disease duration, to evaluate the therapy across a broader patient population with significant unmet medical needs.
Initial Clinical Results Demonstrate Encouraging Activity in Systemic Sclerosis
The presentation includes data from the first four systemic sclerosis patients treated through the June 12, 2026 data cutoff. Three participants received FT819 following less-intensive conditioning chemotherapy using cyclophosphamide or bendamustine alone, while one participant received the investigational therapy without conditioning chemotherapy. All four patients achieved a Revised Composite Response Index in Systemic Sclerosis (rCRISS) score of 25 or greater, accompanied by meaningful average improvements in the Modified Rodnan Skin Score (mRSS) three months after treatment. These early findings suggest clinically meaningful improvements in disease activity while supporting the feasibility of reduced-intensity or chemotherapy-free treatment approaches.
FT819 Demonstrates Favorable Safety Profile Without Major CAR T-Associated Toxicities
Investigators reported that FT819 was well tolerated across all treated systemic sclerosis participants. No cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD), hypogammaglobulinemia, or treatment-related deaths were observed during the reported follow-up period. The favorable safety profile, combined with encouraging early efficacy, supports continued clinical development of FT819 as a potential outpatient, off-the-shelf CAR T-cell therapy that may eliminate many logistical challenges associated with conventional autologous CAR T-cell treatments.
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Off-the-Shelf iPSC Platform Expands Autoimmune Disease Development Strategy
FT819 is manufactured from a genetically engineered induced pluripotent stem cell (iPSC) master cell bank, enabling standardized, scalable production and immediate availability without requiring patient-specific manufacturing. Beyond systemic sclerosis, FT819 is also being evaluated in systemic lupus erythematosus (SLE) through the ongoing Phase 1 basket study, while Fate Therapeutics plans to initiate a potentially registrational Phase 2 clinical trial in lupus nephritis. The company’s iPSC-derived cellular immunotherapy platform aims to expand access to next-generation CAR T-cell therapies by combining scalable manufacturing, rapid treatment availability, and consistent product quality across multiple autoimmune and oncology indications.
Source: Fate Therapeutics press release
