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Immune cell reprogramming offers hope for stubborn arthritis and Sjogren's

NCT ID NCT07048197

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This early-phase study tests a personalized cell therapy (rapcabtagene autoleucel) in 27 adults with difficult-to-treat rheumatoid arthritis or severe Sjogren's disease. The treatment uses a patient's own immune cells, modified to target and calm the overactive immune system. The main goal is to check safety and how the cells behave in the body, with early signs of effectiveness also being explored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 27 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis (RA) and Sjögren's disease (SJD)

Contacts and locations

Locations

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Brest, 29200, France

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

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