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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Single infusion of Rapcabtagene autoleucel
Novartis Investigative Site
Bordeaux, France
RECRUITINGNovartis Investigative Site
Brest, France
RECRUITINGNovartis Investigative Site
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
Time frame: 24 months
Pharmacokinetic (PK) parameter: Cmax
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Maximum observed blood concentration Cmax).
Time frame: 24 months
PK parameter: Tmax
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Time to reach maximum concentration Tmax).
Time frame: 24 months
PK parameter: T1/2
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Terminal elimination half-life T1/2).
Time frame: 24 months
PK parameter: Clast
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Last measurable concentration Clast).
Time frame: 24 months
PK parameter: Tlast
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Time to reach last measurable concentration Tlast).
Time frame: 24 months
PK parameter: AUC
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Area under plasma concentration -time AUC).
Time frame: 24 months
Novartis Pharmaceuticals
CONTACT
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Le Kremlin-Bicêtre, France
Novartis Investigative Site
Lille, France
RECRUITINGNovartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
RECRUITINGNovartis Investigative Site
Berlin, Germany
RECRUITINGNovartis Investigative Site
Ulm, Germany
RECRUITINGNovartis Investigative Site
Singapore, Singapore
RECRUITINGNovartis Investigative Site
Barcelona, Spain
RECRUITINGNovartis Investigative Site
Madrid, Spain
RECRUITING