FT819 is an investigational, off-the-shelf CAR T-cell therapy derived from clonal, master engineered induced pluripotent stem cell (iPSC) lines. FT819 incorporates a CD19-targeted 1XX chimeric antigen receptor inserted into the T-cell receptor alpha constant locus and is designed to mediate potent and rapid B-cell depletion. Given the central role of B cells in the pathogenesis of autoimmune diseases, FT819 is being developed initially for the treatment of moderate to severe systemic lupus erythematosus, with the potential to expand into additional B-cell–mediated autoimmune indications.
Disease: Lupus Nephritis (NCT07570862)
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Candidate summary:
Disease/Disease category:
- Autoimmune disorders
Official title:
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)
Phases:
- Phase 2
Status:
Not yet recruiting
Country:
- United States
