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Resecabtagene autoleucel - Cabaletta Bio

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Drug Profile

Resecabtagene autoleucel - Cabaletta Bio

Alternative Names: CABA-201; rese-cel

Latest Information Update: 27 Jan 2026

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At a glance

  • Originator Cabaletta Bio
  • Class CAR-T cell therapies; Gene therapies; Immunotherapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Myositis; Systemic scleroderma
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Myasthenia gravis; Myositis; Systemic lupus erythematosus; Systemic scleroderma
  • Phase I Pemphigus vulgaris
  • Preclinical Multiple sclerosis

Most Recent Events

  • 27 Jan 2026 Resecabtagene autoleucel - Cabaletta Bio receives Regenerative Medicine Advanced Therapy (RMAT) status for Systemic scleroderma in USA
  • 12 Jan 2026 Cabaletta plans meeting with US FDA to align on additional registrational cohort design in RESET-MG trial in mid 2026
  • 12 Jan 2026 Cabaletta plans meeting with US FDA to align on additional registrational cohort design in RESET-SSc trial in first half of 2026

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