At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Rapcabtagene autoleucel (biological), Active Comparator Option (other)
- How long the study runs
- Study runs about 95 months (dates as stated)
- About the drug or intervention
- Rapcabtagene autoleucel — biological: Single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days. · Active Comparator Option — other: Investigator choice of treatment as per protocol
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 21
- Started
- 2024-12-17
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for idiopathic inflammatory myopathies
- • Phase2 - 21 participants
- • 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)
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with idiopathic inflammatory myopathies
Where?
- • Sheffield - Novartis Investigative Site
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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)
More detail
This is a Phase 2, randomized, active-controlled study. This study comprises two cohorts: * A lead-in cohort enrolling participants to receive rapcabtagene autoleucel * A randomized cohort with participants receiving either rapcabtagene autoleucel or a comparator option. Participants in the comparator arm whose signs and symptoms are not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participants who had inadequate response to prior therapy
- ✓Participant must meet criteria for severe myositis such as presence of active muscle weakness.
Who cannot take part
- ✗BMI at Screening of ≤17 or ≥40 kg/m2
- ✗Severe muscle damage at Screening
- ✗Inhealthy organ
- ✗Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant...
- ✗Other inflammatory and non-inflammatory myopathies
See the full criteria
Where Is This Study? (2 UK sites)
Novartis Investigative Site
Sheffield S10 2JF, United Kingdom
Novartis Investigative Site
London NW1 2BU, United Kingdom
