FDA clears CABA-201 IND for Phase 1/2 myositis study; DesCAARTes updates provided

Cabaletta Bio, Inc.

FDA cleared second IND for CABA-201 (CD19-CAR T) for Phase 1/2 trial in active myositis (DM, ASyS, IMNM) at 1x10^6 cells/kg dose.
Company plans to enroll 18 patients in three parallel cohorts (6 each) for dermatomyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy.
DesCAARTes trial: modest persistence increase in first two patients in IVIg+Cy combination cohort; new fludarabine+IVIg+Cy cohort to be initiated.
MusCAARTes study timelines being evaluated based on emerging DesCAARTes data.
Myositis subtypes targeted affect ~66,000 patients in the US; current treatments often refractory.

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