Clareo Health | A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease
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Keep this study
Lead
Novartis Pharmaceuticals
The study is intended to assess safety, cellular kinetics and any early sign for efficacy of rapcabtagene autoleucel in participants with difficult-to-treat rheumatoid arthritis (D2T RA) and severe, refractory Sjogren's disease (srSjD) with organ involvement.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
