Phase 2 Study of Rapcabtagene Autoleucel for Myositis
This study is testing a treatment called rapcabtagene autoleucel for people with severe idiopathic inflammatory myopathies (IIM), which are muscle diseases. Rapcabtagene autoleucel is a type of CAR-T therapy, which uses your own modified immune cells to fight the disease. You might receive a single infusion of rapcabtagene autoleucel after some preparation therapy, or your doctor might choose another standard treatment. The study aims to see if rapcabtagene autoleucel can lead to a moderate-to-major improvement in your symptoms after 52 weeks. You can join if you are 18 to 75 years old, have a confirmed diagnosis of myositis, and haven't responded well to previous treatments. The study plans to enroll 21 participants, but its current recruitment status is unclear.
- Study design
- This is a Phase 2, randomized, open-label study with an active comparator, meaning some participants will receive the study treatment and others will receive a standard treatment. The study plans to enroll 21 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- If you receive rapcabtagene autoleucel, you will enter a long-term follow-up period after the study ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2 Study of Rapcabtagene Autoleucel in Myositis
At a glance
Conditions
Where it's being run
68 sites across 40 statesStudy leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Proportion of participants achieving moderate- to-major improvement in Total Improvement Score (TIS) at Week 52Week 52
The percentage of participants with a TIS of at least 40 at the 52nd week after the start of the study, corresponding to moderate-to-major improvement.