Last Update: May 27, 2026 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 ClinicalTrials.gov Identifier: [NCT07048197](https://clinicaltrials.gov/ct2/show/NCT07048197) Novartis Reference Number:CYTB323M12101B [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease 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. Condition Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD) Phase Phase1, Phase2 Overall Status Recruiting Number of Participants27 Start Date Jun 20, 2025 Completion Date Nov 01, 2028 Gender All Age(s) 18 Years - 75 Years (Adult, Older Adult) ## Interventions Biological ### Rapcabtagene autoleucel Single infusion of Rapcabtagene autoleucel ## Eligibility Criteria 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. France #### Novartis Investigative Site Recruiting Bordeaux,33076,France #### Novartis Investigative Site Recruiting Le Kremlin-Bicêtre,94275,France #### Novartis Investigative Site Recruiting Brest,29200,France #### Novartis Investigative Site Recruiting Lille,59037,France Germany #### Novartis Investigative Site Recruiting Berlin,13353,Germany #### Novartis Investigative Site Recruiting Ulm,89081,Germany #### Novartis Investigative Site Recruiting Freiburg im Breisgau,Baden-Wurttemberg,79106,Germany #### Novartis Investigative Site Recruiting Cologne,North Rhine-Westphalia,50937,Germany #### Novartis Investigative Site Recruiting Göttingen,Lower Saxony,37075,Germany Singapore #### Novartis Investigative Site Recruiting Singapore,119074,Singapore Spain #### Novartis Investigative Site Recruiting Madrid,28034,Spain #### Novartis Investigative Site Recruiting Barcelona,08035,Spain ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: