Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
juin 2025
novembre 2028
02 mars 2026
A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene
autoleucel in rheumatoid arthritis and Sjogren's disease
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Cristina CASTILLA-LLORENTE | 04/05/2026 08:10:05 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Novartis Investigative Site - 29200 - Brest 3030300 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 33076 - Bordeaux 3031582 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 59037 - Lille 2998324 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94275 - Le Kremlin-Bicêtre 3003737 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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.