RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
About This Trial
A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease
Who May Be Eligible (Plain English)
Who May Qualify:
- Signed willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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
- Inyour organs (liver, kidneys, etc.) are working well enough based on blood tests 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 willing to sign a consent form impossible
Other protocol-defined inclusion/exclusion criteria may apply.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
Rapcabtagene autoleucel
Single infusion of Rapcabtagene autoleucel
Locations (11)
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
Cologne, North Rhine-Westphalia, 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