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

Launched by NOVARTIS PHARMACEUTICALS · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called rapcabtagene autoleucel for people with difficult-to-treat rheumatoid arthritis (RA) or severe Sjögren’s disease (SjD), both of which are conditions where the immune system attacks the body, causing pain and other symptoms. The main goals are to see if this treatment is safe, to understand how it works in the body, and to explore whether it might help improve symptoms.

Adults aged 18 to 65 with active RA or SjD who haven’t had success with standard treatments may be eligible to join the study. Participants will need to agree to certain health and safety requirements, such as not being pregnant or having certain infections or other health issues. During the trial, participants will receive the study treatment and be closely monitored to see how their bodies respond and if there are any side effects. This is an early-phase study, meaning it’s one of the first times this treatment is being tested in people with these conditions, so safety is a top priority.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent must be obtained prior to participation in the study
• • Men and women aged ≥ 18 years and ≤ 65 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
• Exclusion Criteria:
• • BMI at Screening of ≤18.5 or ≥35 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.