Cabaletta Bio receives FDA clearance for third CABA-201 IND, now in systemic sclerosis

Cabaletta Bio, Inc.

Third IND clearance for CABA-201 (CD19-CAR T) in systemic sclerosis within past 6 months.
Phase 1/2 trial to enroll two parallel cohorts: severe skin (n=6) and severe organ involvement (n=6).
Starting dose 1×10^6 cells/kg, same as lupus and myositis trials; three-month data expected by H1 2024.
SSc affects ~88,000 US patients; average survival ~12 years after diagnosis with limited treatments.
Trial part of CARTA strategy aiming to reset immune system via transient B-cell elimination.

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