Actively Recruiting
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
Led by Autolus Limited · Updated on 2026-04-27
35
Participants Needed
26
Research Sites
193 weeks
Total Duration
On this page
Sponsors
A
Autolus Limited
Lead Sponsor
P
PPD Development, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial aims to find out if obe-cel gets rid of harmful B cells that contribute to systemic lupus erythematosus (SLE)/lupus nephritis (LN) when available treatments have not worked (refractory). The trial includes only 1 group of patients (single arm), including adolescent and adult patients aged 12 to 65 years. The objective is to look for benefits of obe-cel in making signs of LN completely disappear (remission) at 6 months after obe-cel treatment in patients with severe, active LN. The trial will also look for other benefits of obe-cel for up to 24 months after treatment, including the percentage of patients who respond to obe-cel treatment, SLE/LN activity, time to and length of remission, and quality of life. The trial will also assess how long obe-cel stays in the body and the safety of obe-cel.
CONDITIONS
Official Title
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give written informed consent or have consent signed by a legal guardian
- Able and willing to follow the study schedule and requirements
- Aged 12 to 65 years at consent
- Female participants must not be pregnant or breastfeeding
- Diagnosed with systemic lupus erythematosus (SLE) meeting 2019 EULAR/ACR criteria
- Positive for antinuclear antibodies, anti-dsDNA, or anti-Smith antibodies
- Have severe active SLE with a SLEDAI-2K score of 8 or higher
- Have severe active lupus nephritis confirmed by kidney biopsy within 6 months
- Have refractory SLE unresponsive to early therapies, calcineurin inhibitors, and B cell-targeting agents
You will not qualify if you...
- Using any medications prohibited by the study protocol
- Prior treatment with anti-CD19 therapy at any time
- More than one severe lupus flare during screening requiring immediate treatment or preventing immunosuppressive washout
- Significant irreversible organ damage from SLE making treatment unlikely to help
- History of primary antiphospholipid antibody syndrome
- Active or uncontrolled fungal, bacterial, or viral infections
- History of cancer unless disease-free for at least 24 months
- History of heart, lung, kidney, liver, or stem cell transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Banner MD Anderson Cancer Center at Canyon Springs
Gilbert, Arizona, United States, 85234
Active, Not Recruiting
2
City of Hope
Duarte, California, United States, 91010
Active, Not Recruiting
3
Stanford University
Stanford, California, United States, 94305
Active, Not Recruiting
4
Tampa General Hospital
Tampa, Florida, United States, 33606
Active, Not Recruiting
5
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Active, Not Recruiting
6
Emory
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
7
The Tisch Cancer Institute - 1470 Madison Avenue
New York, New York, United States, 10029
Active, Not Recruiting
8
State University of New York Upstate Medical Center (SUNY)
Syracuse, New York, United States, 13210
Active, Not Recruiting
9
Texas Childrens Hospital/Baylor
Houston, Texas, United States, 77030
Active, Not Recruiting
10
Accurate Clinical Research Inc - Victoria
Houston, Texas, United States, 77034
Active, Not Recruiting
11
Texas Transplant Institute
San Antonio, Texas, United States, 78229
Active, Not Recruiting
12
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Estado de Bahia, Brazil, 40050
Active, Not Recruiting
13
Hospital Sao Rafael
Salvador, Estado de Bahia, Brazil, 41253
Active, Not Recruiting
14
Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, Brazil, 80030-110
Active, Not Recruiting
15
DASA - Hospital Nove de Julho
São Paulo, Brazil, 01228-200
Active, Not Recruiting
16
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, Brazil, 01327-001
Active, Not Recruiting
17
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-000
Active, Not Recruiting
18
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Active, Not Recruiting
19
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom, B15 2TH
Active, Not Recruiting
20
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS1 3LH
Active, Not Recruiting
21
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
22
Western General Hospital Edinburgh - PPDS
Edinburgh, United Kingdom, EH4 2XU
Active, Not Recruiting
23
Queen Elizabeth University Hospital - PPDS
Glasgow, United Kingdom, G51 4TF
Active, Not Recruiting
24
University College Hospital - PPDS
London, United Kingdom, MW1 2PG
Actively Recruiting
25
Great Ormond Street Hospital - PPDS
London, United Kingdom, WC1N 3JH
Active, Not Recruiting
26
Manchester Royal Infirmary - PPDS
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
A
Autolus Ltd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here