NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease
A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease
RecruitingPhase 1, Phase 2
Sponsor: Novartis Pharmaceuticals
Conditions: Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)
Interventions: Rapcabtagene autoleucel
Countries: France, Germany, Singapore, Spain
A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease
Eligibility overview
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
Locations (12)
- Bordeaux, France
- Brest, France
- Le Kremlin-Bicêtre, France
- Lille, France
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Göttingen, Lower Saxony, Germany
- Cologne, North Rhine-Westphalia, Germany
- Berlin, Germany
- Ulm, Germany
- Singapore, Singapore
- Barcelona, Spain
- Madrid, Spain