Lupus NephritisPhase 2LUMINANCT07053800
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
A Phase 2 study testing Obecabtagene autoleucel in people with Lupus Nephritis, run by Autolus Limited at 16 sites in 5 countries.
Trial summary
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN). Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Obecabtagene autoleucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 16 Jan 2026to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- Severe, Active SLE defined as:
- SLEDAI-2K score of ≥ 8 points AND
- Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV)
- Refractory SLE defined as failure to previous lines of therapy
Who cannot join
- 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
Trial locations and contacts
16 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 5 countries
United Kingdom8 sites, 8 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
UHBHaematologyResearchTeam@uhb.nhs.uk
- Recruiting
Bristol Haematology and Oncology Centre
Bristol, BS1 3LH
BHOCClinicalTrials@uhbw.nhs.uk
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
fatemeh.alemi@nhs.net
- Recruiting
Western General Hospital Edinburgh
Edinburgh, EH4 2XU
loth.rdoffice@nhs.scot
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
ggc.glasgowcrf.generic@nhs.scot
- Recruiting
University College Hospital
London, MW1 2PG
- Recruiting
Great Ormond Street Hospital
London, WC1N 3JH
- Recruiting
Manchester Royal Infirmary
Manchester, M13 9WL
United States4 sites, 4 recruiting
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
Texas Transplant Institute
San Antonio, Texas, 78229
- Recruiting
State University of New York Upstate Medical Center (SUNY)
Syracuse, New York, 13210
Greece2 sites, 2 recruiting
- Recruiting
University General Hospital ATTIKON
Athens, 12461
- Recruiting
University General Hospital of Patras
Pátrai, 26504
Brazil1 site, 1 recruiting
- Recruiting
Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia, 41253-190
About this study
Official title: 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
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).
Read the detailed description
This is a Phase 2 study to determine the efficacy and safety of obe-cel in participants with severe, refractory SLE with active LN.
The study comprises 3 periods:
- Screening Period: From Day -30 (+7) to Day of Enrollment
- Treatment Period: From Day -8 to Day 1 - Participants will be evaluated to confirm eligibility for lymphodepletion, and thereafter receive lymphodepletion. Obe-cel Administration: If the participant's eligibility for receiving obe-cel infusion is confirmed, the participant is to receive a single obe-cel infusion on Day 1.
- Post-treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation.
- Conditions
- Lupus Nephritis
- Being tested
- Obecabtagene autoleucel
- Keywords
- Systemic lupus erythematosus, Refractory systemic lupus erythematosus, Lupus nephritis, Obecabtagene autoleucel, Obe-cel
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obecabtagene autoleucelBiological
Also called Obe-cel
Obecabtagene autoleucel (obe-cel) given as a single infusion
| Study group | Role | What they receive |
|---|---|---|
| Obe-cel | Experimental | Not described Receives: Biological: Obecabtagene autoleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve complete renal response (CRR)
CRR is a composite endpoint
Measured: Month 6
Secondary outcomes (13)
Proportion of participants achieving remission per Definition of Remission in SLE (DORIS) criteria
DORIS is a composite endpoint
Measured: Month 6
Proportion of participants achieving CRR over time
CRR is a composite endpoint
Measured: Up to Month 24
Time to CRR
CRR is a composite endpoint
Measured: Up to Month 24
Proportion of participants with Partial Renal Response (PRR)
PRR is a composite endpoint
Measured: Up to Month 24
Time to PRR
PRR is a composite endpoint
Measured: Up to Month 24
Proportion of participants achieving remission per DORIS criteria over time
DORIS is a composite endpoint
Measured: Up to Month 24
Time to achieving remission per DORIS criteria
DORIS is a composite endpoint
Measured: Up to Month 24
Time to renal flare
Renal flare is a composite endpoint
Measured: Up to Month 24
Proportion of participants achieving Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 0 over time
SLEDAI-2K is a composite index of disease activity
Measured: Up to Month 24
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) over time
LLDAS is a composite endpoint
Measured: Up to Month 24
Time to LLDAS
LLDAS is a composite endpoint
Measured: Up to Month 24
Time to first disease flare according to Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI-2K Flare Index (SFI) post-obe-cel infusion
SFI is a composite index to identify disease flares
Measured: Up to Month 24
To evaluate safety of obe-cel
Proportion of participants with adverse events (AEs)
Measured: Up to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start16 Jan 2026
- Primary completionAug 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, single group assignment, open-label
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Autolus Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053800
- Sponsor's protocol ID
- AUTO1-SL2
- Other IDs
- 2024-519941-32, 1011415
- Acronym
- LUMINA
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07053800
- Acronym / sponsor ID
- LUMINA / AUTO1-SL2
- Conditions
- Lupus Nephritis
- Keywords
- Systemic lupus erythematosus, Refractory systemic lupus erythematosus, Lupus nephritis, Obecabtagene autoleucel, Obe-cel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Autolus LimitedIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).
Detailed description
This is a Phase 2 study to determine the efficacy and safety of obe-cel in participants with severe, refractory SLE with active LN.
The study comprises 3 periods:
- Screening Period: From Day -30 (+7) to Day of Enrollment
- Treatment Period: From Day -8 to Day 1 - Participants will be evaluated to confirm eligibility for lymphodepletion, and thereafter receive lymphodepletion. Obe-cel Administration: If the participant's eligibility for receiving obe-cel infusion is confirmed, the participant is to receive a single obe-cel infusion on Day 1.
- Post-treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, single group assignment, open-label
| Arm | Type | Receives |
|---|---|---|
| Obe-cel | Experimental | Biological: Obecabtagene autoleucel |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obecabtagene autoleucelAlso: Obe-celObecabtagene autoleucel (obe-cel) given as a single infusion | Biological | Obe-cel |
Primary outcome
Proportion of participants who achieve complete renal response (CRR)
Time frame: Month 6
CRR is a composite endpoint
13 secondary outcomes
Proportion of participants achieving remission per Definition of Remission in SLE (DORIS) criteria
Time frame: Month 6
Proportion of participants achieving CRR over time
Time frame: Up to Month 24
Time to CRR
Time frame: Up to Month 24
Proportion of participants with Partial Renal Response (PRR)
Time frame: Up to Month 24
Time to PRR
Time frame: Up to Month 24
Proportion of participants achieving remission per DORIS criteria over time
Time frame: Up to Month 24
Time to achieving remission per DORIS criteria
Time frame: Up to Month 24
Time to renal flare
Time frame: Up to Month 24
Proportion of participants achieving Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 0 over time
Time frame: Up to Month 24
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) over time
Time frame: Up to Month 24
Time to LLDAS
Time frame: Up to Month 24
Time to first disease flare according to Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI-2K Flare Index (SFI) post-obe-cel infusion
Time frame: Up to Month 24
To evaluate safety of obe-cel
Time frame: Up to Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obecabtagene autoleucel in people with Lupus Nephritis, run by Autolus Limited at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom, United States, Greece, Brazil, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Autolus Ltd (+44 (0)203 911 4385, clinicaltrials@autolus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who achieve complete renal response (CRR) (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 5 Nov 2026.