ClinicaliQ Trial Snapshot
- Phase 2 Study of Rapcabtagene Autoleucel in Myositis — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT06665256.
- What is being tested: Rapcabtagene autoleucel, a CAR T-cell therapy, is being evaluated against a comparator treatment in patients with severe refractory idiopathic inflammatory myopathies (IIM) to assess its efficacy and safety in this treatment-resistant population.
- Patient eligibility overview: The trial enrolls participants with severe refractory IIM who have failed conventional immunosuppressive therapies, representing a clinically challenging group with limited treatment options.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 (IIM)
Eligibility Snapshot
- Key Inclusion Criteria: 1. Men and women, aged ≥ 18 and ≤75 years, with a diagnosis of probable or definite myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria
- Participants who had inadequate response to prior therapy 3. Diagnosed with active disease such as presence of at least 1 of the following criteria: abnormal enzyme levels assessed as secondary to IIM, or EMG demonstrating active disease, DM skin rash, muscle biopsy demonstrating active IIM, or MRI demonstrating active inflammation.
- Participant must meet criteria for severe myositis such as presence of active muscle weakness. Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.