Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
123 participants
INTERVENTIONAL
2024-12-17
2030-07-17
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel (YTB323)
Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.
Comparator
Investigator choice of treatment as per protocol
Active Comparator Option
Investigator choice of treatment as per protocol
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants who had inadequate response to prior therapy
3. Diagnosed with active disease
4. Participant must meet criteria for severe myositis
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University Of Alabama
Birmingham, Alabama, United States
FL Medical Clinic Orlando Health
Zephyrhills, Florida, United States
Northwestern University
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University Of Iowa
Iowa City, Iowa, United States
LDS Hospital
Salt Lake City, Utah, United States
Novartis Investigative Site
Brest, , France
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Lille, , France
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Lyon, , France
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Paris, , France
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Rennes, , France
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Cologne, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Jena, Thuringia, Germany
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Aachen, , Germany
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Hamburg, , Germany
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Mainz, , Germany
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Nuremberg, , Germany
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Ulm, , Germany
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Haifa, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Brescia, BS, Italy
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Monza, MB, Italy
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Milan, MI, Italy
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Sapporo, Hokkaido, Japan
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Kanazawa, Ishikawa-ken, Japan
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Yokohama, Kanagawa-ku, Japan
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Sendai, Miyagi, Japan
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Suita, Osaka, Japan
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Izumo, Shimane, Japan
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Bunkyo-ku, Tokyo, Japan
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Bunkyo-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Fukuoka, , Japan
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Kyoto, , Japan
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Amsterdam, North Holland, Netherlands
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Riyadh, , Saudi Arabia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Santiago Compostela, A Coruna, Spain
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Santander, Cantabria, Spain
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Pamplona, Navarre, Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Salamanca, , Spain
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Geneva, , Switzerland
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Sheffield, South Yorkshire, United Kingdom
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London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CYTB323L12201
Identifier Type: -
Identifier Source: org_study_id
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