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

Phase 2/3 Recruiting 74 enrolled Cabaletta Bio

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2023-12-20
Primary completion: 2028-07
Completion: 2028-07

Publications

Volkov J, Nunez D, Mozaffar T, Stadanlick J, Werner M, Vorndran Z, Ellis A, Williams J, Cicarelli J, Lam Q, Furmanak T, Schmitt C, Hadi-Nezhad F, Thompson D, Miller C, Little C, Chang D, Basu S. Case study of CD19 CAR T therapy in a subject with immune-mediate necrotizing myopathy treated in the RESET-Myositis phase I/II trial. Mol Ther. 2024 Nov 6;32(11):3821-3828. doi: 10.1016/j.ymthe.2024.09.009. Epub 2024 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	resecabtagene autoleucel	Cell therapy	—	Intravenous
Background	Cyclophosphamide	Other / unclassified	—	—
Background	Fludarabine	Small molecule	—	—

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

Summary

Timeline

Publications

Drugs

Indications