RESET-Myositis: An Open-Label Study to Evaluate the Safety & Efficacy of

Status Recruiting

Clinical Trial Summary

RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy

Clinical Trial Description

Idiopathic inflammatory myopathies (IIMs, or myositis) are a group of rare autoimmune diseases characterized by inflammation and muscle weakness. Though the cause of IIM is not well understood, some subtypes of IIM, including dermatomyositis (DM), anti-synthetase syndrome (ASyS), and immune-mediated necrotizing myopathy (IMNM), are thought to involve B cells that cause the body to attack different tissues in the body. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, that can be given to patients with DM, ASyS, and IMNM who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06154252
Study type	Interventional
Source	Cabaletta Bio
Contact	Cabaletta Bio
Phone	12677593100
Email	clinicaltrials@cabalettabio.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	December 20, 2023
Completion date	July 2028

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See also
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RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms