Cabaletta Bio posts corporate presentation on rese-cel CD19 CAR-T autoimmune disease programs

Cabaletta Bio

Cabaletta Bio

CABA

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  • Cabaletta Bio outlined plans to submit a BLA for rese-cel in dermatomyositis in 2H27, including adult DM and juvenile DM data.
  • Safety update across 63 preconditioned patients: 94% had no CRS or Grade 1 CRS; 97% had no ICANS, supporting outpatient use.
  • In Phase 1/2 DM, 83% of adult patients would have met the registrational endpoint; the first JDM patient maintained response at 32 weeks.
  • Systemic sclerosis positioned as the second pivotal indication; a roughly 25-patient single-arm registrational study is expected to start in 4Q26.
  • PC-free rese-cel showed deep B-cell depletion in some lupus and pemphigus vulgaris patients; automated manufacturing with Cellares highlighted to cut COGS.


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