Trial intelligence / Profile preview

RESET-Myositis

2025-521145-24-01Phase 2Authorised

Sponsor
Cabaletta Bio
Start
Apr 2026
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Gene Therapies
Countries
5
01

Overview

Phase 2, open-label, single-arm trial of resecabtagene autoleucel in Autoimmune Myopathies, juvenile myositis (JM), dermatomyositis (DM) and 2 more, sponsored by Cabaletta Bio. Primary endpoint: Incidence and severity of adverse events. Planned start Apr 2026; status: authorised.

02

Drugs

resecabtagene autoleucel
03

Conditions

Autoimmune Myopathiesjuvenile myositis (JM)dermatomyositis (DM)antisynthetase syndrome (ASSD)immune-mediated necrotizing myopathy (IMNM)

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