The FDA has granted Fast Track designation to Cabaletta Bio's CABA-201 cell therapy for systemic lupus erythematosus (SLE) and lupus nephritis (LN). The therapy targets CD19-positive B cells to induce an 'immune system reset' for patients with SLE. The upcoming phase 1/2 clinical trial will enroll two cohorts, one with active LN and the other without renal involvement, with a one-time infusion of 1.0 x 10^6 cells/kg. Fast Track designation expedites drug development for serious conditions with unmet medical needs.
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by Lucy Hicks at www.medscape.com 05-02-2023
https://www.medscape.com/viewarticle/991501Deeper Inquiries