Fate Therapeutics has announced encouraging initial data from the FT819 phase 1 autoimmunity study for people with moderate-to-severe systemic lupus erythematosus (SLE). The ongoing trial is evaluating safety, pharmacokinetics, and efficacy of FT819 in targeting CD19+ B cell activity.

FT819 is an off-the-shelf, CAR-T cellinvestigational therapy that incorporates a novel 1XX Chimeric Antigen Receptor (CAR) targeting CD19, which is inserted into the T-cell receptor to selectively target and deplete B cells. In the study, three participants with active lupus nephritis (LN) received chemotherapy followed by a single infusion of FT819 at a dose of 360 million cells. No dose-limiting toxicities were observed. Early results showed rapid, deep, and sustained depletion of CD19+ B cells within the first month of treatment.  

The first participant treated remains in drug-free clinical remission, and early data from the other two participants demonstrate the potential for significant disease improvement. The study also includes a second treatment arm where FT819 is being evaluated as an add-on to maintenance therapy without prior chemotherapy; one participant has been treated in this cohort. 

Based on the positive clinical observations, Fate Therapeutics is advancing the trial by initiating dose expansion in up to 10 participants at the 360-million-cell dose level and then escalating the dose to 720 million cells. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more aboutmedications used to treat lupus. 

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