Rapcabtagene autoleucel (CAR-T) for rheumatoid arthritis and Sjögren'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
This trial will test rapcabtagene autoleucel, a CAR‑T cell therapy, in adults with difficult‑to‑treat rheumatoid arthritis or severe, refractory Sjögren's disease to see if it is safe and shows early signs of benefit.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 11 sites (Bordeaux and 10 other locations) |
| Trial ID | NCT07048197 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 trial gives adults with difficult‑to‑treat rheumatoid arthritis (D2T RA) or severe, refractory Sjögren's disease (srSjD) an investigational CAR‑T product called rapcabtagene autoleucel. Participants undergo collection of their T cells, which are engineered ex vivo and then re‑infused, while study teams track safety events and how the modified cells expand and persist in the body (cellular kinetics). The study also collects early exploratory measures of clinical activity using disease‑specific outcomes. The primary focus in these early phases is safety and characterizing the product's behavior rather than proving definitive long‑term efficacy.
Who should consider this trial
Good fit: Adults aged 18–75 with difficult‑to‑treat rheumatoid arthritis or adults with severe, refractory Sjögren's disease with organ involvement who have failed standard therapies and meet safety criteria may be eligible.
Not a fit: Patients with active or recurrent serious infections, inadequate organ function, recent or prior malignancy, extreme BMI outside study limits, or women who are pregnant or breastfeeding are unlikely to qualify or benefit from participation.
Why it matters
Potential benefit: If successful, this therapy could produce meaningful symptom improvement or prolonged remission for patients who have not responded to standard treatments.
How similar studies have performed: CAR‑T approaches for autoimmune diseases are a novel and early area of research with limited but promising early clinical signals rather than large confirmed successes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bordeaux and 10 other locations
- Novartis Investigative Site — Bordeaux, France (Recruiting)
- Novartis Investigative Site — Brest, France (Recruiting)
- Novartis Investigative Site — Le Kremlin-Bicêtre, France (Recruiting)
- Novartis Investigative Site — Lille, France (Recruiting)
- Novartis Investigative Site — Freiburg im Breisgau, Baden-Wurttemberg, Germany (Recruiting)
- Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Novartis Investigative Site — Berlin, Germany (Recruiting)
- Novartis Investigative Site — Ulm, Germany (Recruiting)
- Novartis Investigative Site — Singapore, Singapore (Recruiting)
- Novartis Investigative Site — Barcelona, Spain (Recruiting)
- Novartis Investigative Site — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.