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Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Obecabtagene autoleucel (biological)
How long the study runs: Study runs about 45 months (dates as stated)
About the drug or intervention: Obecabtagene autoleucel — biological: Obecabtagene autoleucel (obe-cel) given as a single infusion
Patient visit burden: Not specified by the sponsor

In plain English

This study is testing a treatment called obe-cel in people aged 12 to 65 with severe systemic lupus erythematosus (SLE, often called lupus) that has not got better with earlier treatment, and who also have active lupus nephritis (LN) — a type of lupus that affects the kidneys. To join, participants must have a kidney biopsy showing a certain type of kidney involvement. The sponsor is Autolus Limited.

Who can take part

Aged 12 to 65, with consent given by the person or a legal guardian or representative
A diagnosis of SLE based on the 2019 EULAR/ACR criteria (European League Against Rheumatism and American College of Rheumatology)
A positive test for at least one of these antibodies: antinuclear antibodies (ANA), anti-dsDNA, or anti-Smith
Severe, active lupus with a SLEDAI-2K score of 8 or more (a measure of lupus activity)
Active lupus nephritis confirmed by a kidney biopsy showing class III, IV, or V (class V only alongside class III or IV)
Lupus that has not improved after earlier treatment (called refractory)
If female, not pregnant or breastfeeding

Who may not be able to

Previous treatment with anti-CD19 therapy at any time
More than one sudden severe lupus flare during screening that needs immediate treatment or makes stopping existing immunosuppressant medicines impossible
Significant, likely permanent organ damage from lupus (such as end-stage kidney disease) that, in the researchers' view, means CD19 CAR T cell therapy is unlikely to help
A history of primary antiphospholipid antibody syndrome
An active or uncontrolled fungal, bacterial, or viral infection
A history of cancer, unless cancer-free for at least 24 months
Previous transplant of the heart, lungs, kidneys, or liver, or a blood stem cell transplant

What taking part involves

• Not stated — ask the trial team. The study involves a treatment called obe-cel, described in the registry as CD19 CAR T cell therapy, but details of what participants receive are not given.

Time commitment: Not stated — ask the trial team. Participants must be willing and able to follow the study's schedule of activities, but the number of visits and how long the study lasts are not stated.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 12 Years to 65 Years
Who: All
Number of participants: 35
Started: 2026-01-16
Last checked: 2026-08

Plain English Summary

What is this study?

• Testing a new treatment for lupus nephritis
• Phase2 - 35 participants
• 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)

Who can take part?

• Ages 12 Years to 65 Years
• Diagnosed with lupus nephritis

Where?

• Birmingham - Queen Elizabeth Hospital Birmingham
• Bristol - Bristol Haematology and Oncology Centre
• Cambridge - Addenbrooke's Hospital
• Edinburgh - Western General Hospital Edinburgh
• +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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: 1. Screening Period: From Day -30 (+7) to Day of Enrollment 2. 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. 3. Post-treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation.

Lupus Nephritis

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 12 Years - 65 Years
Who can join: All genders

Biomarkers mentioned

CD19

What the study is looking for

✓Willing and able to give written agreement to take part for participation in the study or written agreement to take part signed...
✓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 agreement to take part.
✓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...

Who cannot take part

✗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...
✗Significant, likely irreversible organ damage related to SLE (e.g., end-stage kidney disease) that in the opinion of...
✗History of primary antiphospholipid antibody syndrome
✗Active or uncontrolled fungal, bacterial, or viral infection

See the full criteria

Inclusion Criteria: * 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: * 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 Exclusion Criteria: * 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