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

Plain Language Summary

Simplified for easier understanding

This study is testing rapcabtagene autoleucel — a CAR-T cell therapy — for people with two autoimmune diseases: rheumatoid arthritis (RA) and Sjogren's disease. CAR-T therapy (normally used in blood cancers) is being explored as a way to reset the immune system in severe autoimmune conditions that haven't responded to standard treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed rheumatoid arthritis OR Sjogren's disease with active disease - You have failed standard treatments for your condition **You may NOT be eligible if...** - Your BMI is 17 or below, or 40 or above - You have a significant active or chronic infection - You have a history of cancer or lymphoma - You have had a prior bone marrow or organ transplant - You are pregnant, breastfeeding, or not using adequate contraception - You have inadequate organ function or a psychiatric condition preventing consent or compliance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRapcabtagene 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

View Full Details on ClinicalTrials.gov

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NCT07048197