Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07048197

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

Led by Novartis Pharmaceuticals · Updated on 2026-03-30

27

Participants Needed

11

Research Sites

175 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent must be obtained prior to participation in the study
  • Men and women aged 65 18 years and 64 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
Not Eligible

You will not qualify if you...

  • BMI at Screening of 6417 or 64 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Novartis Investigative Site

Bordeaux, France, 33076

Actively Recruiting

2

Novartis Investigative Site

Brest, France, 29200

Actively Recruiting

3

Novartis Investigative Site

Le Kremlin-Bicêtre, France, 94275

Actively Recruiting

4

Novartis Investigative Site

Lille, France, 59037

Actively Recruiting

5

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106

Actively Recruiting

6

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany, 50937

Actively Recruiting

7

Novartis Investigative Site

Berlin, Germany, 13353

Actively Recruiting

8

Novartis Investigative Site

Ulm, Germany, 89081

Actively Recruiting

9

Novartis Investigative Site

Singapore, Singapore, 119074

Actively Recruiting

10

Novartis Investigative Site

Barcelona, Spain, 08035

Actively Recruiting

11

Novartis Investigative Site

Madrid, Spain, 28034

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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