RecruitingPhase 1Phase 2NCT07048197

A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease

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

Novartis Pharmaceuticals

Enrollment

27 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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 Criteria9

  • 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

Interventions

BIOLOGICALRapcabtagene autoleucel

Single infusion of Rapcabtagene autoleucel


Locations(10)

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, Germany

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

View Full Details on ClinicalTrials.gov

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NCT07048197