Actively Recruiting
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
Led by Novartis Pharmaceuticals · Updated on 2026-02-20
179
Participants Needed
93
Research Sites
387 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 criteria
- Positive for at least one lupus autoantibody: ANA (titer ≥1:80), anti-dsDNA, or anti-Sm
- Active lupus nephritis without significant chronic damage or active SLE
- SLEDAI-2K score of 6 or higher at screening, excluding fever, lupus headache, alopecia, or organic brain syndrome
- Inadequate response to at least two prior therapies
You will not qualify if you...
- Acute, severe lupus flare needing immediate treatment other than pulse glucocorticoids or making immunosuppressive washout impossible
- Inadequate organ function at screening
- History or current ECG or cardiac abnormalities posing safety risks
- Positive for HIV at screening
- Acute or chronic hepatitis B or hepatitis 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
Trial Site Locations
Total: 93 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
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
14
Univ Of TX MD Anderson CC
Houston, Texas, United States, 77030
Actively Recruiting
15
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
LDS Hospital
Salt Lake City, Utah, United States, 84143
Actively Recruiting
17
LDS Hospital
Salt Lake City, Utah, United States, 84143
Actively Recruiting
18
Novartis Investigative Site
Clayton, Victoria, Australia, 3168
Actively Recruiting
19
Novartis Investigative Site
Graz, Austria, 8036
Actively Recruiting
20
Novartis Investigative Site
Vienna, Austria, 1090
Actively Recruiting
21
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 41253-190
Actively Recruiting
22
Novartis Investigative Site
Barretos, São Paulo, Brazil, 14784 400
Actively Recruiting
23
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01232-010
Actively Recruiting
24
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01308-050
Actively Recruiting
25
Novartis Investigative Site
São Paulo, Brazil, 01509-010
Actively Recruiting
26
Novartis Investigative Site
Olomouc, Czechia, 779 00
Actively Recruiting
27
Novartis Investigative Site
Prague, Czechia, 128 00
Actively Recruiting
28
Novartis Investigative Site
Prague, Czechia, 128 08
Actively Recruiting
29
Novartis Investigative Site
Aarhus N, Denmark, 8200
Actively Recruiting
30
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
31
Novartis Investigative Site
Marseille, France, 13005
Actively Recruiting
32
Novartis Investigative Site
Nantes, France, 44093
Actively Recruiting
33
Novartis Investigative Site
Paris, France, 75013
Actively Recruiting
34
Novartis Investigative Site
Paris, France, 75014
Actively Recruiting
35
Novartis Investigative Site
Strasbourg, France, 67091
Actively Recruiting
36
Novartis Investigative Site
Toulouse, France, 31054
Actively Recruiting
37
Novartis Investigative Site
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
38
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany, 70376
Actively Recruiting
39
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60528
Actively Recruiting
40
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
41
Novartis Investigative Site
Leipzig, Saxony, Germany, 04103
Actively Recruiting
42
Novartis Investigative Site
Jena, Thuringia, Germany, 07740
Actively Recruiting
43
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
44
Novartis Investigative Site
Mainz, Germany, 55131
Actively Recruiting
45
Novartis Investigative Site
Nuremberg, Germany, 90419
Actively Recruiting
46
Novartis Investigative Site
Ulm, Germany, 89081
Actively Recruiting
47
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
Actively Recruiting
48
Novartis Investigative Site
Budapest, Hungary, H-1083
Actively Recruiting
49
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Actively Recruiting
50
Novartis Investigative Site
Alessandria, AL, Italy, 15121
Actively Recruiting
51
Novartis Investigative Site
Ancona, AN, Italy, 60126
Actively Recruiting
52
Novartis Investigative Site
Genova, GE, Italy, 16132
Actively Recruiting
53
Novartis Investigative Site
Milan, MI, Italy, 20122
Actively Recruiting
54
Novartis Investigative Site
Milan, MI, Italy, 20132
Actively Recruiting
55
Novartis Investigative Site
Rozzano, MI, Italy, 20089
Actively Recruiting
56
Novartis Investigative Site
Pescara, PE, Italy, 65124
Actively Recruiting
57
Novartis Investigative Site
Pisa, PI, Italy, 56126
Actively Recruiting
58
Novartis Investigative Site
Pavia, PV, Italy, 27100
Actively Recruiting
59
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608648
Actively Recruiting
60
Novartis Investigative Site
Kobe, Hyōgo, Japan, 6500047
Actively Recruiting
61
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan, 920 8641
Actively Recruiting
62
Novartis Investigative Site
Yokohama, Kanagawa-ku, Japan, 236-0004
Actively Recruiting
63
Novartis Investigative Site
Sendai, Miyagi, Japan, 9808574
Actively Recruiting
64
Novartis Investigative Site
Suita, Osaka, Japan, 5650871
Actively Recruiting
65
Novartis Investigative Site
Izumo, Shimane, Japan, 693 8501
Actively Recruiting
66
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 1138431
Actively Recruiting
67
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 1138519
Actively Recruiting
68
Novartis Investigative Site
Chiba, Japan, 260 8677
Actively Recruiting
69
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
70
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
71
Novartis Investigative Site
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
72
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Actively Recruiting
73
Novartis Investigative Site
Utrecht, Netherlands, 3584 CX
Actively Recruiting
74
Novartis Investigative Site
Oslo, Norway, 0372
Actively Recruiting
75
Novartis Investigative Site
Bucharest, Romania, 022328
Actively Recruiting
76
Novartis Investigative Site
Riyadh, Saudi Arabia, 11211
Actively Recruiting
77
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
78
Novartis Investigative Site
Seoul, South Korea, 06591
Actively Recruiting
79
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
80
Novartis Investigative Site
Santander, Cantabria, Spain, 39008
Actively Recruiting
81
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
82
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
83
Novartis Investigative Site
Córdoba, Spain, 14004
Actively Recruiting
84
Novartis Investigative Site
Madrid, Spain, 28009
Actively Recruiting
85
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
86
Novartis Investigative Site
Salamanca, Spain, 37007
Actively Recruiting
87
Novartis Investigative Site
Valencia, Spain, 46026
Actively Recruiting
88
Novartis Investigative Site
Stockholm, Sweden, 17176
Actively Recruiting
89
Novartis Investigative Site
Lausanne, Switzerland, 1011
Actively Recruiting
90
Novartis Investigative Site
Taichung, Taiwan, 407219
Actively Recruiting
91
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
92
Novartis Investigative Site
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Actively Recruiting
93
Novartis Investigative Site
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
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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