A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease

Recruiting now · Phase 1/Phase 2

Conditions studied: Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)

In brief

A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease

Key facts

Study ID

NCT07048197

Run by

Novartis Pharmaceuticals

People needed

27

Starts

2025-06-20

Expected to finish

2028-11-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent must be obtained prior to participation in the study
• Men and women aged ≥ 18 years and ≤ 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 may not qualify if…

• BMI at Screening of ≤17 or ≥ 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.

Where it is running

• Novartis Investigative Site — Bordeaux, France (enrolling)
• Novartis Investigative Site — Brest, France (enrolling)
• Novartis Investigative Site — Le Kremlin-Bicêtre, France (enrolling)
• Novartis Investigative Site — Lille, France (enrolling)
• Novartis Investigative Site — Freiburg im Breisgau, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Göttingen, Lower Saxony, Germany (enrolling)
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany (enrolling)
• Novartis Investigative Site — Berlin, Germany (enrolling)
• Novartis Investigative Site — Ulm, Germany (enrolling)
• Novartis Investigative Site — Singapore, Singapore (enrolling)
• Novartis Investigative Site — Barcelona, Spain (enrolling)
• Novartis Investigative Site — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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