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
Sponsor study identifier
Secondary identifiers
OTHER · EU CT
interventional
27
6 countries
14
Study Start
June 20, 2025
Actual (reported)Primary Completion
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 20, 2025
Actual (reported)June 24, 2025
Actual (reported)July 2, 2025
Actual (reported)November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation
24 months
Pharmacokinetic (PK) parameter: Cmax
24 months
PK parameter: Tmax
24 months
Single infusion of Rapcabtagene autoleucel in participants with rheumatoid arthritis
Single infusion of Rapcabtagene autoleucel in participants with Sjögren's Disease
Single infusion of Rapcabtagene autoleucel
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
FLUDARABINE PHOSPHATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
CYCLOPHOSPHAMIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
POWDER FOR SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
TOCILIZUMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
FLUDARABINE PHOSPHATE
Named ingredient: fludarabine phosphate
View registry recordCYCLOPHOSPHAMIDE
Named ingredient: Cyclophosphamide
View registry recordTOCILIZUMAB
Named ingredient: tocilizumab
View registry recordNovartis Investigative Site
Bordeaux, 33076, France
Novartis Investigative Site
Brest, 29200, France
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275, France
Novartis Investigative Site
Lille, 59037, France
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Novartis Investigative Site
Göttingen, Lower Saxony, 37075, Germany
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937, Germany
First Submitted
June 24, 2025
First Posted
July 2, 2025
Study Start
June 20, 2025
Actual (reported)Primary Completion
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
PK parameter: T1/2
24 months
PK parameter: Clast
24 months
PK parameter: Tlast
24 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Ulm, 89081, Germany
Novartis Investigative Site
Singapore, 119074, Singapore
Novartis Investigative Site
Barcelona, 08035, Spain
Novartis Investigative Site
Madrid, 28034, Spain
Study Completion
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 4, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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