A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
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).
2 other identifiers
interventional
179
22 countries
91
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2024
Longer than P75 for phase_2
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedStudy Start
First participant enrolled
September 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 6, 2032
February 20, 2026
February 1, 2026
3.4 years
August 23, 2024
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of rapcabtagene autoleucel
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 Outcomes (7)
Percentage of participants achieving complete renal response (CRR)
Week 52
Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved
Week 12 to Week 52
PPercentage of participants without flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares)
Week 12 to Week 52
Annualized cumulative corticosteroids dose
Week 52
Percentage of participants who are negative for serological status
Week 52
- +2 more secondary outcomes
Study Arms (1)
rapcabtagene autoleucel
EXPERIMENTALrapcabtagene autoleucel
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
University Of Alabama
Birmingham, Alabama, 35294, United States
Loma Linda University
San Bernardino, California, 92408, United States
UCSF
San Francisco, California, 94115, United States
UCSF
San Francisco, California, 94115, United States
Sutter Health Network
San Pablo, California, 94806, United States
Ann and Robert H Lurie Childs Hosp
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
University Of Iowa
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536-0284, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
WA Uni School Of Med
St Louis, Missouri, 63110, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Univ Of TX MD Anderson CC
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Novartis Investigative Site
Clayton, Victoria, 3168, Australia
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Graz, 8036, Austria
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Vienna, 1090, Austria
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Salvador, Estado de Bahia, 41253-190, Brazil
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Barretos, São Paulo, 14784 400, Brazil
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São Paulo, São Paulo, 01232-010, Brazil
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São Paulo, São Paulo, 01308-050, Brazil
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São Paulo, 01509-010, Brazil
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Olomouc, 779 00, Czechia
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Prague, 128 00, Czechia
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Prague, 128 08, Czechia
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Aarhus N, 8200, Denmark
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Bordeaux, 33076, France
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Marseille, 13005, France
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Nantes, 44093, France
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Paris, 75013, France
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Paris, 75014, France
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Strasbourg, 67091, France
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Toulouse, 31054, France
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Vandœuvre-lès-Nancy, 54511, France
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Stuttgart, Baden-Wurttemberg, 70376, Germany
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Frankfurt am Main, Hesse, 60528, Germany
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Cologne, North Rhine-Westphalia, 50937, Germany
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Leipzig, Saxony, 04103, Germany
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Jena, Thuringia, 07740, Germany
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Essen, 45147, Germany
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Mainz, 55131, Germany
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Nuremberg, 90419, Germany
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Ulm, 89081, Germany
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Debrecen, Hajdu Bihar Megye, 4032, Hungary
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Budapest, H-1083, Hungary
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Ramat Gan, 5265601, Israel
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Alessandria, AL, 15121, Italy
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Ancona, AN, 60126, Italy
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Genova, GE, 16132, Italy
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Milan, MI, 20122, Italy
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Milan, MI, 20132, Italy
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Rozzano, MI, 20089, Italy
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Pescara, PE, 65124, Italy
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Pisa, PI, 56126, Italy
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Pavia, PV, 27100, Italy
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Sapporo, Hokkaido, 0608648, Japan
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Kobe, Hyōgo, 6500047, Japan
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Kanazawa, Ishikawa-ken, 920 8641, Japan
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Yokohama, Kanagawa-ku, 236-0004, Japan
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Sendai, Miyagi, 9808574, Japan
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Suita, Osaka, 5650871, Japan
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Izumo, Shimane, 693 8501, Japan
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Bunkyo Ku, Tokyo, 1138431, Japan
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Bunkyo-ku, Tokyo, 1138519, Japan
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Chiba, 260 8677, Japan
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Fukuoka, 8128582, Japan
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Kyoto, 6068507, Japan
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Leiden, South Holland, 2333 ZA, Netherlands
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Groningen, 9713 GZ, Netherlands
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Utrecht, 3584 CX, Netherlands
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Oslo, 0372, Norway
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Bucharest, 022328, Romania
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Riyadh, 11211, Saudi Arabia
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Singapore, 119074, Singapore
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Seoul, 06591, South Korea
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Santiago Compostela, A Coruna, 15706, Spain
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Santander, Cantabria, 39008, Spain
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Pamplona, Navarre, 31008, Spain
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Barcelona, 08035, Spain
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Córdoba, 14004, Spain
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Madrid, 28009, Spain
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Madrid, 28041, Spain
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Salamanca, 37007, Spain
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Valencia, 46026, Spain
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Stockholm, 17176, Sweden
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Lausanne, 1011, Switzerland
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Taichung, 407219, Taiwan
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Taipei, 10002, Taiwan
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Sheffield, South Yorkshire, S10 2JF, United Kingdom
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London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2024
First Posted
September 3, 2024
Study Start
September 4, 2024
Primary Completion (Estimated)
February 14, 2028
Study Completion (Estimated)
February 6, 2032
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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.