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A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease
Led by Novartis Pharmaceuticals · Updated on 2026-03-30
27
Participants Needed
11
Research Sites
175 weeks
Total Duration
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AI-Summary
What this Trial Is About
A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease
CONDITIONS
Official Title
A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent must be obtained prior to participation in the study
- Men and women aged 65 18 years and 64 75 years at Screening For RA only
- Diagnosis of rheumatoid arthritis
- Treatment failure of standard of care therapies
- Active disease For SjD only
- Diagnosis of Sjogren's disease
- Active disease
You will not qualify if you...
- BMI at Screening of 6417 or 64 40 kg/m2
- Clinically significant active, opportunistic, chronic or recurrent infection
- Sexually active males unwilling to use a condom during intercourse from the time enrollment
- Women of childbearing potential, unless they are using a highly effective method of contraception starting from the time of enrollment
- Female participants who are pregnant, breastfeeding or intending to conceive during the course of the study
- Inadequate organ function during screening
- History of lymphoproliferative disease or any known malignancy or history of malignancy
- History of bone marrow/hematopoietic stem cell or solid organ transplantation
- Any psychiatric condition or disability making compliance with treatment or informed consent impossible
- Other protocol-defined inclusion/exclusion criteria may apply.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Novartis Investigative Site
Bordeaux, France, 33076
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2
Novartis Investigative Site
Brest, France, 29200
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3
Novartis Investigative Site
Le Kremlin-Bicêtre, France, 94275
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4
Novartis Investigative Site
Lille, France, 59037
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5
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
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6
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
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7
Novartis Investigative Site
Berlin, Germany, 13353
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8
Novartis Investigative Site
Ulm, Germany, 89081
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9
Novartis Investigative Site
Singapore, Singapore, 119074
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10
Novartis Investigative Site
Barcelona, Spain, 08035
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11
Novartis Investigative Site
Madrid, Spain, 28034
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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