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.

NCT06665256

Phase 2 Study of Rapcabtagene Autoleucel in Myositis

Active, Not Recruiting
PHASE2Ages 18–75InterventionalTreatment
Novartis Pharmaceuticals
~21 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Rapcabtagene autoleucelActive Comparator Option

At a glance

Recruiting sites
0 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants achieving moderate- to-major improvement in Total Improvement Score (TIS) at Week 52
Measured over Week 52
Idiopathic Inflammatory Myopathies
68 sites across 40 states
France6
Spain6
Germany5
São Paulo3
Israel3
Tokyo3
Japan3
Singapore3
  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • 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.