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

Más betegség

• Clinically significant active, opportunistic, chronic or recurrent infection
• 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.

Egyéb

• BMI at Screening of ≤17 or ≥ 40 kg/m2
• 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

• 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