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Clinical Trials in the UK / NCT06665256
Active, not recruiting Phase 2

Phase 2 Study of Rapcabtagene Autoleucel in Myositis

NCT06665256 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2024-12-17
Last updated
2026-06-23

Condition(s) studied

Idiopathic Inflammatory Myopathies

Investigational drug(s) / intervention(s)

Rapcabtagene autoleucelActive Comparator Option

Rapcabtagene autoleucel: Single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.

Active Comparator Option: Investigator choice of treatment as per protocol

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
University Of Alabama Birmingham Alabama
FL Medical Clinic Orlando Health Zephyrhills Florida
Augusta University Georgia Augusta Georgia
Northwestern University Chicago Illinois
University Of Iowa Iowa City Iowa
Duke Clinical Research Institute Durham North Carolina
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Baylor University Medical Center Dallas Texas
Houston Methodist Hospital Houston Texas
LDS Hospital Salt Lake City Utah
Novartis Investigative Site Melbourne Victoria
Novartis Investigative Site Barretos São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site Brest France
Novartis Investigative Site Lille France
Novartis Investigative Site Lyon France
Novartis Investigative Site Marseille France
Novartis Investigative Site Paris France
Novartis Investigative Site Rennes France
Novartis Investigative Site Cologne North Rhine-Westphalia
Novartis Investigative Site Leipzig Saxony
Novartis Investigative Site Jena Thuringia
Novartis Investigative Site Aachen Germany
Novartis Investigative Site Hamburg Germany
Novartis Investigative Site Mainz Germany
Novartis Investigative Site Nuremberg Germany
Novartis Investigative Site Ulm Germany
Novartis Investigative Site Haifa Israel
Novartis Investigative Site Ramat Gan Israel
Novartis Investigative Site Tel Aviv Israel
Novartis Investigative Site Ancona AN
Novartis Investigative Site Brescia BS
Novartis Investigative Site Monza MB
Novartis Investigative Site Milan MI
Novartis Investigative Site Rozzano MI
Novartis Investigative Site Verona VR
Novartis Investigative Site Sapporo Hokkaido
Novartis Investigative Site Yokohama Kanagawa
Novartis Investigative Site Sendai Miyagi

+ 28 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06665256 on ClinicalTrials.gov ↗ ← All trials in the UK