RecruitingPhase 1Phase 2NCT07048197
A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease
An Open-label, Multi-center, Phase 1/2 Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Participants With Difficult-to-treat Rheumatoid Arthritis and Severe, Refractory Sjogren's Disease With Organ Involvement
Sponsor
Novartis Pharmaceuticals
Enrollment
27 participants
Start Date
Jun 20, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- 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
Exclusion Criteria9
- 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
Interventions
BIOLOGICALRapcabtagene autoleucel
Single infusion of Rapcabtagene autoleucel
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07048197