Actively Recruiting
A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel in Patients With Active, Refractory Systemic Lupus Erythematosus or Lupus Nephritis
Led by Novartis Pharmaceuticals · Updated on 2026-06-03
179
Participants Needed
101
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of rapcabtagene autoleucel in adults with active, treatment-resistant systemic lupus erythematosus (SLE) or lupus nephritis (LN). This phase 2, open-label study focuses on patients who have not responded adequately to at least two prior therapies and meet specific criteria for disease activity and antibody presence. Participants will receive a single infusion of rapcabtagene autoleucel after lymphodepletion. The study includes monitoring at weeks 24 and 52 to assess how well the treatment works. This approach aims to understand if this biological therapy can improve lupus symptoms and kidney involvement. During the trial, participants will undergo regular evaluations including disease activity scores, kidney response, flare frequency, corticosteroid use, serological status, and fatigue levels. Researchers will closely monitor safety and long-term effects up to week 76, with follow-up visits to assess treatment durability and participant well-being.
CONDITIONS
Brief Title
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 75 years with systemic lupus erythematosus (SLE) meeting 2019 EULAR/ACR classification criteria
- Positive for at least one autoantibody: ANA (≥ 1:80), anti-dsDNA, or anti-Sm as confirmed by central laboratory
- Active lupus nephritis without significant chronic damage or active systemic lupus erythematosus
- SLEDAI-2K score of 6 or higher at screening, excluding specific symptoms like fever or alopecia
- Inadequate response to at least two prior therapies
You will not qualify if you...
- Severe acute lupus flare requiring immediate treatment beyond pulse corticosteroids making immunosuppressive washout impossible
- Inadequate organ function before randomization
- History or current significant cardiac or ECG abnormalities posing safety risks
- Positive for HIV infection at screening
- Acute or chronic hepatitis B or C infection at screening
- Grade 2 or higher thromboembolic event within 4 weeks before screening
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive a single infusion of rapcabtagene autoleucel as the study treatment.
Multiple visits for treatment and assessments up to Week 52
Duration - 24 weeks
Participants are monitored for safety and efficacy outcomes after treatment.
Visits from Week 52 to Week 76 for ongoing assessments
Trial Site Locations
Total: 101 locations
1
University Of Alabama
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Loma Linda University
San Bernardino, California, United States, 92408
Actively Recruiting
3
UCSF
San Francisco, California, United States, 94115
Actively Recruiting
4
UCSF
San Francisco, California, United States, 94115
Actively Recruiting
5
Sutter Health Network
San Pablo, California, United States, 94806
Actively Recruiting
6
Ann and Robert H Lurie Childs Hosp
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
8
University Of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
9
University of Kentucky
Lexington, Kentucky, United States, 40536-0284
Actively Recruiting
10
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
11
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
12
WA Uni School Of Med
St Louis, Missouri, United States, 63110
Actively Recruiting
13
Duke Clinical Research Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
14
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
15
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
16
Univ Of TX MD Anderson CC
Houston, Texas, United States, 77030
Actively Recruiting
17
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
18
LDS Hospital
Salt Lake City, Utah, United States, 84143
Actively Recruiting
19
LDS Hospital
Salt Lake City, Utah, United States, 84143
Actively Recruiting
20
Novartis Investigative Site
Clayton, Victoria, Australia, 3168
Actively Recruiting
21
Novartis Investigative Site
Graz, Austria, 8036
Actively Recruiting
22
Novartis Investigative Site
Vienna, Austria, 1090
Actively Recruiting
23
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 41253-190
Actively Recruiting
24
Novartis Investigative Site
Barretos, São Paulo, Brazil, 14784 400
Actively Recruiting
25
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01232-010
Actively Recruiting
26
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01308-050
Actively Recruiting
27
Novartis Investigative Site
São Paulo, Brazil, 01509-010
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28
Novartis Investigative Site
Olomouc, Czechia, 779 00
Actively Recruiting
29
Novartis Investigative Site
Prague, Czechia, 128 00
Actively Recruiting
30
Novartis Investigative Site
Prague, Czechia, 128 08
Actively Recruiting
31
Novartis Investigative Site
Aarhus N, Denmark, 8200
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32
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
33
Novartis Investigative Site
Clermont-Ferrand, France, 63003
Actively Recruiting
34
Novartis Investigative Site
Marseille, France, 13005
Actively Recruiting
35
Novartis Investigative Site
Nantes, France, 44093
Actively Recruiting
36
Novartis Investigative Site
Paris, France, 75013
Actively Recruiting
37
Novartis Investigative Site
Paris, France, 75014
Actively Recruiting
38
Novartis Investigative Site
Strasbourg, France, 67091
Actively Recruiting
39
Novartis Investigative Site
Toulouse, France, 31054
Actively Recruiting
40
Novartis Investigative Site
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
41
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany, 70376
Actively Recruiting
42
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60528
Actively Recruiting
43
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
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44
Novartis Investigative Site
Leipzig, Saxony, Germany, 04103
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45
Novartis Investigative Site
Jena, Thuringia, Germany, 07740
Actively Recruiting
46
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
47
Novartis Investigative Site
Lübeck, Germany, 23538
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48
Novartis Investigative Site
Mainz, Germany, 55131
Actively Recruiting
49
Novartis Investigative Site
Nuremberg, Germany, 90419
Actively Recruiting
50
Novartis Investigative Site
Ulm, Germany, 89081
Actively Recruiting
51
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
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52
Novartis Investigative Site
Budapest, Hungary, H-1083
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53
Novartis Investigative Site
Haifa, Israel, 3109601
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54
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Actively Recruiting
55
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Actively Recruiting
56
Novartis Investigative Site
Alessandria, AL, Italy, 15121
Actively Recruiting
57
Novartis Investigative Site
Ancona, AN, Italy, 60126
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58
Novartis Investigative Site
Genova, GE, Italy, 16132
Actively Recruiting
59
Novartis Investigative Site
Milan, MI, Italy, 20122
Actively Recruiting
60
Novartis Investigative Site
Milan, MI, Italy, 20132
Actively Recruiting
61
Novartis Investigative Site
Rozzano, MI, Italy, 20089
Actively Recruiting
62
Novartis Investigative Site
Pescara, PE, Italy, 65124
Actively Recruiting
63
Novartis Investigative Site
Pisa, PI, Italy, 56126
Actively Recruiting
64
Novartis Investigative Site
Pavia, PV, Italy, 27100
Actively Recruiting
65
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-8648
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66
Novartis Investigative Site
Kobe, Hyōgo, Japan, 6500047
Actively Recruiting
67
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
68
Novartis Investigative Site
Sendai, Miyagi, Japan, 9808574
Actively Recruiting
69
Novartis Investigative Site
Suita, Osaka, Japan, 565-0871
Actively Recruiting
70
Novartis Investigative Site
Izumo, Shimane, Japan, 6938501
Actively Recruiting
71
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 1138431
Actively Recruiting
72
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 1138519
Actively Recruiting
73
Novartis Investigative Site
Chiba, Japan, 2608677
Actively Recruiting
74
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
75
Novartis Investigative Site
Ishikawa, Japan, 9208641
Actively Recruiting
76
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
77
Novartis Investigative Site
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
78
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Actively Recruiting
79
Novartis Investigative Site
Utrecht, Netherlands, 3584 CX
Actively Recruiting
80
Novartis Investigative Site
Oslo, Norway, 0372
Actively Recruiting
81
Novartis Investigative Site
Bucharest, Romania, 022328
Actively Recruiting
82
Novartis Investigative Site
Riyadh, Saudi Arabia, 11211
Actively Recruiting
83
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
84
Novartis Investigative Site
Seoul, South Korea, 04763
Actively Recruiting
85
Novartis Investigative Site
Seoul, South Korea, 06351
Actively Recruiting
86
Novartis Investigative Site
Seoul, South Korea, 06591
Actively Recruiting
87
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
88
Novartis Investigative Site
Santander, Cantabria, Spain, 39008
Actively Recruiting
89
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
90
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
91
Novartis Investigative Site
Córdoba, Spain, 14004
Actively Recruiting
92
Novartis Investigative Site
Madrid, Spain, 28009
Actively Recruiting
93
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
94
Novartis Investigative Site
Salamanca, Spain, 37007
Actively Recruiting
95
Novartis Investigative Site
Valencia, Spain, 46026
Actively Recruiting
96
Novartis Investigative Site
Stockholm, Sweden, 17176
Actively Recruiting
97
Novartis Investigative Site
Lausanne, Switzerland, 1011
Actively Recruiting
98
Novartis Investigative Site
Taichung, Taiwan, 407219
Actively Recruiting
99
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
100
Novartis Investigative Site
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Actively Recruiting
101
Novartis Investigative Site
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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