Overview
A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease
Description
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
Other protocol-defined inclusion/exclusion criteria may apply.
