Trial Profile

A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Systemic Sclerosis

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 16 May 2026

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At a glance

27 Apr 2026 According to a Cabaletta Bio media release, the data from the trial will be presented at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting.
23 Mar 2026 According to a Cabaletta Bio media release, Complete Phase 1/2 clinical data from cohorts in RESET-SLE and RESET-SSc are expected to support Cabaletta's discussions with the FDA on potential registrational pathways specifically in RESET-SSc and RESET-MG. Cabaletta anticipates providing an update regarding registrational designs for RESET-SSc in 1H26 and for RESET-MG in mid-2026.
10 Nov 2025 According to a Cabaletta Bio media release, company anticipates data from this trial in the first half of 2026.

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