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

Prior treatment

• Any patients requiring medications prohibited by the protocol

Other illness

• Any psychiatric condition or disability making compliance with treatment or informed consent impossible
• 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

Other

• Body Mass Index at screening of ≤17 or ≥40 kg/m2
• Any XX that needs immediate treatment other than XX impossible
• 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
• Difficult-to-treat rheumatoid arthritis: Diagnosis of rheumatoid arthritis
• Difficult-to-treat rheumatoid arthritis: XX
• Difficult-to-treat rheumatoid arthritis: Treatment failure of standard of care therapies
• Difficult-to-treat rheumatoid arthritis: Signs suggestive of active, progressive disease
• Severe refractory Sjogren's Disease: Diagnosis of Sjogren’s disease
• Severe refractory Sjogren's Disease: XX
• Severe refractory Sjogren's Disease: Severe systemic, refractory disease with moderate to high disease activity