A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (NCT06665256)

The CYTB323L12201 study is designed to evaluate the safety and efficacy of rapcabtagene autoleucel (CAR-T) compared to standard of care treatment in participants with idiopathic inflammatory myopathies (IIM). Participants will be randomised into either a CAR-T infusion or a comparator option. After the end of study participants who received the CAR-T infusion will enter a long-term follow-up period lasting up to 15 years.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Yuan Lim

Key inclusion data

Aged 18 to 65 at time of screening; Have a diagnosis of probable or definite myositis; Must have an inadequate response to high dose corticosteroids and have had an inadequate response to two standard treatments for your disease.