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ACTIVE NOT RECRUITINGPhase2

Phase 2 Study of Rapcabtagene Autoleucel in Myositis

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT06665256

View on ClinicalTrials.gov ↗

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.

Idiopathic Inflammatory Myopathies

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

CD19

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
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 2. 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. 4. Participant must meet criteria for severe myositis such as presence of active muscle weakness. Key Exclusion Criteria: 1. Any condition during Screening that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study 2. BMI at Screening of ≤17 or ≥40 kg/m2 3. Severe muscle damage at Screening 4. Inadequate organ function 5. Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol 6. Other inflammatory and non-inflammatory myopathies 7. Any medical conditions that are not related to IIM that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy Other protocol-defined inclusion/exclusion criteria may apply.

Where Is This Study? (2 UK sites)

Novartis Investigative Site

Sheffield S10 2JF, United Kingdom

Novartis Investigative Site

London NW1 2BU, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-06