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

NCT ID: NCT07048197

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2028-11-01

Brief Summary

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

Detailed Description

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The study is intended to assess safety, cellular kinetics and any early sign for efficacy of rapcabtagene autoleucel in participants with difficult-to-treat rheumatoid arthritis (D2T RA) and severe, refractory Sjogren's disease (srSjD) with organ involvement.

Conditions

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Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)

Keywords

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CAR-T, YTB323, rapcabtagene autoleucel, D2T RA, srSjD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rapcabtagene autoleucel-rheumatoid arthritis

Single infusion of Rapcabtagene autoleucel in participants with rheumatoid arthritis

Group Type EXPERIMENTAL

Rapcabtagene autoleucel

Intervention Type BIOLOGICAL

Single infusion of Rapcabtagene autoleucel

Rapcabtagene autoleucel- Sjögren's Disease

Single infusion of Rapcabtagene autoleucel in participants with Sjögren's Disease

Group Type EXPERIMENTAL

Rapcabtagene autoleucel

Intervention Type BIOLOGICAL

Single infusion of Rapcabtagene autoleucel

Interventions

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Rapcabtagene autoleucel

Single infusion of Rapcabtagene autoleucel

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Bordeaux, , France

Site Status RECRUITING

Novartis Investigative Site

Brest, , France

Site Status RECRUITING

Novartis Investigative Site

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Novartis Investigative Site

Lille, , France

Site Status RECRUITING

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Ulm, , Germany

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Countries

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France Germany Singapore Spain

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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2024-514596-18-00

Identifier Type: OTHER

Identifier Source: secondary_id

CYTB323M12101B

Identifier Type: -

Identifier Source: org_study_id