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A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

NCT ID: NCT06581198

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

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2032-02-06

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).

Detailed Description

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Conditions

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Lupus Erythematosus, Systemic Lupus Nephritis

Keywords

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Chimeric Antigen Receptor-T (CAR-T) rapcabtagene autoleucel Lupus Nephritis (LN) Systemic Lupus Erythematosus (SLE)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rapcabtagene autoleucel

rapcabtagene autoleucel

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

* Men and women with SLE, aged \>= 18 years and =\< 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening.
* Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of \>= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.
* Active lupus nephritis without signs of significant chronicity or active systemic lupus erythematosus
* SLEDAI-2K Criteria at screening: SLEDAI-2K score \>= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome".
* Inadequate response at screening to at least two therapies

Exclusion Criteria

* Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy
* Inadequate organ function during screening and prior to randomization
* History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization
* Human immunodeficiency virus (HIV) positivity at screening.
* Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening.
* Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.
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

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University Of Alabama

Birmingham, Alabama, United States

Site Status RECRUITING

Loma Linda University

San Bernardino, California, United States

Site Status RECRUITING

UCSF

San Francisco, California, United States

Site Status RECRUITING

UCSF

San Francisco, California, United States

Site Status RECRUITING

Sutter Health Network

San Pablo, California, United States

Site Status RECRUITING

Ann and Robert H Lurie Childs Hosp

Chicago, Illinois, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University Of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

WA Uni School Of Med

St Louis, Missouri, United States

Site Status RECRUITING

Oregon Health Sciences University

Portland, Oregon, United States

Site Status RECRUITING

Univ Of TX MD Anderson CC

Houston, Texas, United States

Site Status RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

LDS Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

LDS Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

Novartis Investigative Site

Clayton, Victoria, Australia

Site Status RECRUITING

Novartis Investigative Site

Graz, , Austria

Site Status RECRUITING

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Vienna, , Austria

Site Status RECRUITING

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Salvador, Estado de Bahia, Brazil

Site Status RECRUITING

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São Paulo, São Paulo, Brazil

Site Status RECRUITING

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São Paulo, São Paulo, Brazil

Site Status RECRUITING

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São Paulo, , Brazil

Site Status RECRUITING

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Olomouc, , Czechia

Site Status RECRUITING

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Prague, , Czechia

Site Status RECRUITING

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Aarhus N, , Denmark

Site Status RECRUITING

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Bordeaux, , France

Site Status RECRUITING

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Marseille, , France

Site Status RECRUITING

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Nantes, , France

Site Status RECRUITING

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Paris, , France

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Paris, , France

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Toulouse, , France

Site Status RECRUITING

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Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

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Stuttgart, Baden-Wurttemberg, Germany

Site Status RECRUITING

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Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

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Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

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Leipzig, Saxony, Germany

Site Status RECRUITING

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Jena, Thuringia, Germany

Site Status RECRUITING

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Essen, , Germany

Site Status RECRUITING

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Mainz, , Germany

Site Status RECRUITING

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Nuremberg, , Germany

Site Status RECRUITING

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Ulm, , Germany

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Debrecen, Hajdu Bihar Megye, Hungary

Site Status RECRUITING

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Budapest, , Hungary

Site Status RECRUITING

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Ancona, AN, Italy

Site Status RECRUITING

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Genova, GE, Italy

Site Status RECRUITING

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Milan, MI, Italy

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Milan, MI, Italy

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Rozzano, MI, Italy

Site Status RECRUITING

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Pisa, PI, Italy

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Pavia, PV, Italy

Site Status RECRUITING

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Sapporo, Hokkaido, Japan

Site Status RECRUITING

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Kobe, Hyōgo, Japan

Site Status RECRUITING

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Kanazawa, Ishikawa-ken, Japan

Site Status RECRUITING

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Yokohama, Kanagawa-ku, Japan

Site Status RECRUITING

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Sendai, Miyagi, Japan

Site Status RECRUITING

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Suita, Osaka, Japan

Site Status RECRUITING

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Izumo, Shimane, Japan

Site Status RECRUITING

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Bunkyo Ku, Tokyo, Japan

Site Status RECRUITING

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Bunkyo-ku, Tokyo, Japan

Site Status RECRUITING

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Chiba, , Japan

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Fukuoka, , Japan

Site Status RECRUITING

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Kyoto, , Japan

Site Status RECRUITING

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Leiden, South Holland, Netherlands

Site Status RECRUITING

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Groningen, , Netherlands

Site Status RECRUITING

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Utrecht, , Netherlands

Site Status RECRUITING

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Oslo, , Norway

Site Status RECRUITING

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Bucharest, , Romania

Site Status RECRUITING

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Riyadh, , Saudi Arabia

Site Status RECRUITING

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Singapore, , Singapore

Site Status RECRUITING

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Seoul, , South Korea

Site Status RECRUITING

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Santiago Compostela, A Coruna, Spain

Site Status RECRUITING

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Santander, Cantabria, Spain

Site Status RECRUITING

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Pamplona, Navarre, Spain

Site Status RECRUITING

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Barcelona, , Spain

Site Status RECRUITING

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Córdoba, , Spain

Site Status RECRUITING

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Madrid, , Spain

Site Status RECRUITING

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Madrid, , Spain

Site Status RECRUITING

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Salamanca, , Spain

Site Status RECRUITING

Novartis Investigative Site

Valencia, , Spain

Site Status RECRUITING

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Stockholm, , Sweden

Site Status RECRUITING

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Lausanne, , Switzerland

Site Status RECRUITING

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Taichung, , Taiwan

Site Status RECRUITING

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Taipei, , Taiwan

Site Status RECRUITING

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Sheffield, South Yorkshire, United Kingdom

Site Status RECRUITING

Novartis Investigative Site

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Austria Brazil Czechia Denmark France Germany Hungary Italy Japan Netherlands Norway Romania Saudi Arabia Singapore South Korea Spain Sweden Switzerland Taiwan United Kingdom

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Facility Contacts

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Laura Laupus

Role: primary

Alejandra Beltran

Role: primary

Zilan Zheng

Role: primary

Zilan Zheng

Role: primary

Canary Jumawan

Role: primary

Eric Brown

Role: primary

Neil Pillai

Role: primary

Darby Donovan

Role: primary

Dorothy Ross

Role: primary

Angela Chavez

Role: primary

Bharath Miriyam

Role: primary

Michelle Bloom

Role: primary

Kim Phung Karimzadeh

Role: primary

Cattleya Musni

Role: primary

Maria Suarez-Almazor

Role: primary

Tara Sou

Role: primary

Tara Sou

Role: primary

Other Identifiers

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2023-510150-17-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CYTB323J12201

Identifier Type: -

Identifier Source: org_study_id