Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
LUMINA
A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
3 other identifiers
interventional
35
3 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2026
Typical duration for phase_2
26 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
May 13, 2025
CompletedFirst Posted
Study publicly available on registry
July 8, 2025
CompletedStudy Start
First participant enrolled
January 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
April 27, 2026
April 1, 2026
2.5 years
May 13, 2025
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants who achieve complete renal response (CRR) at 6 months post-obe-cel infusion without rescue medications, among all participants who received obe-cel infusion
CRR is defined as change in * urine protein creatinine ratio (UPCR) and * estimated glomerular filtration rate (eGFR) and * without use of rescue medication
Month 6
Secondary Outcomes (21)
Proportion of participants who achieve response according to Definition of Remission in SLE (DORIS) at 6 months post-obe-cel infusion, among all patients who received obe-cel infusion
Month 6
Proportion of participants with CRR.
Up to Month 24
Time to CRR
Up to Month 24
Duration of CRR.
Up to Month 24
Proportion of participants with Partial Renal Response (PRR)
Up to Month 24
- +16 more secondary outcomes
Study Arms (1)
Obe-cel
EXPERIMENTALInterventions
Obecabtagene autoleucel (obe-cel) given as a single infusion
Eligibility Criteria
You may qualify if:
- Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative
- Ability and willingness to adhere to protocol's Schedule of Activities and other requirements
- Participants must be 12 to 65 years of age inclusive at the time of signing the informed consent.
- Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding
- Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus.
- Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith.
- Severe, Active SLE defined as:
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 8 points AND
- Severe active LN based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V (V only in combination with class III or IV)
- Refractory SLE defined as failure to early lines of therapy and to Calcineurin inhibitors AND B cell-targeting agents
You may not qualify if:
- Any medications prohibited by the protocol.
- Prior treatment at any time with anti-CD19 therapy.
- More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible.
- Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant.
- History of primary antiphospholipid antibody syndrome.
- Active or uncontrolled fungal, bacterial, or viral infection
- History of malignant neoplasms unless disease free for at least 24 months.
- History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Autolus Limitedlead
- PPD Development, LPcollaborator
Study Sites (26)
Banner MD Anderson Cancer Center at Canyon Springs
Gilbert, Arizona, 85234, United States
City of Hope
Duarte, California, 91010, United States
Stanford University
Stanford, California, 94305, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Emory
Atlanta, Georgia, 30322, United States
The Tisch Cancer Institute - 1470 Madison Avenue
New York, New York, 10029, United States
State University of New York Upstate Medical Center (SUNY)
Syracuse, New York, 13210, United States
Texas Childrens Hospital/Baylor
Houston, Texas, 77030, United States
Accurate Clinical Research Inc - Victoria
Houston, Texas, 77034, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Estado de Bahia, 40050, Brazil
Hospital Sao Rafael
Salvador, Estado de Bahia, 41253, Brazil
Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, 80030-110, Brazil
DASA - Hospital Nove de Julho
São Paulo, 01228-200, Brazil
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, 01327-001, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-010, Brazil
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS1 3LH, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Western General Hospital Edinburgh - PPDS
Edinburgh, EH4 2XU, United Kingdom
Queen Elizabeth University Hospital - PPDS
Glasgow, G51 4TF, United Kingdom
University College Hospital - PPDS
London, MW1 2PG, United Kingdom
Great Ormond Street Hospital - PPDS
London, WC1N 3JH, United Kingdom
Manchester Royal Infirmary - PPDS
Manchester, M13 9WL, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
May 13, 2025
First Posted
July 8, 2025
Study Start
January 16, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
October 1, 2029
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share