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

June 2, 2026 updated by: Novartis Pharmaceuticals

A Phase 2, Open-label, Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel in Patients With Active, Refractory Systemic Lupus Erythematosus (SLE) or Active, Refractory Lupus Nephritis (LN).

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2, adaptive, five-year, randomized, assessor-blinded, active controlled study:

  • Part A: Participants suffering from systemic lupus erythematosus (SLE) with active, refractory LN will be randomized to Regimen 1, Regimen 2, or SOC.
  • Part B: Participants suffering from SLE with active, refractory LN will be randomized to the selected regimen from Part A or SOC.

The study will consist of two periods:

  • A screening period lasting up to 6 weeks, and
  • A randomized treatment period and primary follow-up period lasting up to 5 years.

Participants in the SoC arm whose signs and symptoms are not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible.

Study Type

Interventional

Enrollment (Estimated)

179

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Novartis Investigative Site
      • Vienna, Austria, 1090
        • Recruiting
        • Novartis Investigative Site
  • Brazil
      • São Paulo, Brazil, 01509-010
        • Recruiting
        • Novartis Investigative Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41253-190
        • Recruiting
        • Novartis Investigative Site
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784 400
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 01308-050
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 01232-010
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 128 00
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 128 08
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Novartis Investigative Site
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Novartis Investigative Site
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Novartis Investigative Site
      • Marseille, France, 13005
        • Recruiting
        • Novartis Investigative Site
      • Nantes, France, 44093
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75014
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75013
        • Recruiting
        • Novartis Investigative Site
      • Strasbourg, France, 67091
        • Recruiting
        • Novartis Investigative Site
      • Toulouse, France, 31054
        • Recruiting
        • Novartis Investigative Site
      • Vandœuvre-lès-Nancy, France, 54511
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Lübeck, Germany, 23538
        • Recruiting
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Recruiting
        • Novartis Investigative Site
      • Nuremberg, Germany, 90419
        • Recruiting
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Recruiting
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70376
        • Recruiting
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60528
        • Recruiting
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Germany, 07740
        • Recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H-1083
        • Recruiting
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Recruiting
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • AL
      • Alessandria, AL, Italy, 15121
        • Recruiting
        • Novartis Investigative Site
    • AN
      • Ancona, AN, Italy, 60126
        • Recruiting
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20122
        • Recruiting
        • Novartis Investigative Site
      • Milan, MI, Italy, 20132
        • Recruiting
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Recruiting
        • Novartis Investigative Site
    • PE
      • Pescara, PE, Italy, 65124
        • Recruiting
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56126
        • Recruiting
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Chiba, Japan, 2608677
        • Recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 8128582
        • Recruiting
        • Novartis Investigative Site
      • Ishikawa, Japan, 9208641
        • Recruiting
        • Novartis Investigative Site
      • Kyoto, Japan, 6068507
        • Recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Novartis Investigative Site
    • Hyōgo
      • Kobe, Hyōgo, Japan, 6500047
        • Recruiting
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
        • Recruiting
        • Novartis Investigative Site
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Recruiting
        • Novartis Investigative Site
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • Novartis Investigative Site
    • Shimane
      • Izumo, Shimane, Japan, 6938501
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo Ku, Tokyo, Japan, 1138431
        • Recruiting
        • Novartis Investigative Site
      • Bunkyo-ku, Tokyo, Japan, 1138519
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Novartis Investigative Site
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Novartis Investigative Site
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Recruiting
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway, 0372
        • Recruiting
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Novartis Investigative Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • Recruiting
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 06591
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06351
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 04763
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
      • Córdoba, Spain, 14004
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Recruiting
        • Novartis Investigative Site
      • Salamanca, Spain, 37007
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Recruiting
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spain, 15706
        • Recruiting
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Novartis Investigative Site
  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • Novartis Investigative Site
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 407219
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Novartis Investigative Site
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama
        • Principal Investigator:
          • Jose Enrique Rubio Mosquera
        • Contact:
    • California
      • San Bernardino, California, United States, 92408
        • Recruiting
        • Loma Linda University
        • Principal Investigator:
          • Sayna Norouzi
        • Contact:
      • San Francisco, California, United States, 94115
        • Recruiting
        • UCSF
        • Principal Investigator:
          • Emily Von Scheven
        • Contact:
      • San Pablo, California, United States, 94806
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • George Georges
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann and Robert H Lurie Childs Hosp
        • Principal Investigator:
          • Sonali Chaudhury
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Principal Investigator:
          • Hanna Zembrzuska
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • Recruiting
        • University Of Kentucky
        • Principal Investigator:
          • Paramarajan Piranavan
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Principal Investigator:
          • Hanni Menn-Josephy
        • Contact:
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Andreas Klein
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • WA Uni School Of Med
        • Principal Investigator:
          • Tingting Li
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Clinical Research Institute
        • Principal Investigator:
          • Kris Mahadeo
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Sciences University
        • Principal Investigator:
          • Atul Deodhar
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Samer Srour
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Univ Of TX MD Anderson CC
        • Principal Investigator:
          • Samer Srour
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • Recruiting
        • LDS Hospital
        • Principal Investigator:
          • Catherine Jennifer Bakewell
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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

Key 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rapcabtagene autoleucel
Biological: rapcabtagene autoleucel
single infusion of rapcabtagene autoleucel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy of rapcabtagene autoleucel
Time Frame: Week 24, Week 52

Defined as:

Meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS)

or

Achieving complete renal response (CRR)
Week 24, Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving complete renal response (CRR)
Time Frame: Week 52
CRR is a composite endpoint
Week 52
Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved
Time Frame: Week 12 to Week 52
Lupus Low Disease Activity State (LLDAS)
Week 12 to Week 52
PPercentage of participants without flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares)
Time Frame: Week 12 to Week 52
British Isles Lupus Activity Group (BILAG2004) records disease activity occurring over the past 4 weeks.
Week 12 to Week 52
Annualized cumulative corticosteroids dose
Time Frame: Week 52
The total dose of corticosteroids used up to Week 52 per patient.
Week 52
Percentage of participants who are negative for serological status
Time Frame: Week 52
The percentage of participants with negative serological status
Week 52
FACIT-Fatigue score change from baseline
Time Frame: Baseline to Week 52
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item patient- reported outcomes measure
Baseline to Week 52
Maintained DORIS
Time Frame: Week 52 to Week 76
Definition Of Remission In Systemic Lupus Erythematosus (DORIS)
Week 52 to Week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Estimated)

February 14, 2028

Study Completion (Estimated)

February 6, 2032

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 29, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYTB323J12201
  • 2023-510150-17-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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