Clinical Trials in France / NCT07048197
Active, not recruiting
Phase 1/2
A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease
NCT07048197 · tracked via the Priya Life Science France tracker
Condition(s) studied
Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)
Investigational drug(s) / intervention(s)
Rapcabtagene autoleucel: Single infusion of Rapcabtagene autoleucel
Study summary
A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease
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.
Primary outcome measure(s)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability — 24 months
Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | Bordeaux | France | |
| Novartis Investigative Site | Brest | France | |
| Novartis Investigative Site | Le Kremlin-Bicêtre | France | |
| Novartis Investigative Site | Lille | France | |
| Novartis Investigative Site | Freiburg im Breisgau | Baden-Wurttemberg | |
| Novartis Investigative Site | Göttingen | Lower Saxony | |
| Novartis Investigative Site | Cologne | North Rhine-Westphalia | |
| Novartis Investigative Site | Berlin | Germany | |
| Novartis Investigative Site | Ulm | Germany | |
| Novartis Investigative Site | Singapore | Singapore | |
| Novartis Investigative Site | Barcelona | Spain | |
| Novartis Investigative Site | Madrid | Spain |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07048197 on ClinicalTrials.gov ↗ ← All trials in France