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Clinical Trials in Germany / 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 Germany tracker
Phase
Phase 1/2
Started
2025-06-20
Last updated
2026-09-04

Condition(s) studied

Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)

Investigational drug(s) / intervention(s)

Rapcabtagene autoleucel →

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)

Trial sites (12)

FacilityCityRegionStatus
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

More Novartis Pharmaceuticals trials in Germany

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 Germany