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Obe-cel for Severe Lupus Nephritis

This study is testing a treatment called obecabtagene autoleucel (obe-cel) for people with severe systemic lupus erythematosus (SLE), also known as lupus, who also have active lupus nephritis (LN). Lupus nephritis is a serious kidney complication of lupus. The study aims to see how safe and effective a single infusion of obe-cel is. To join, you must be between 12 and 65 years old and have severe, difficult-to-treat lupus with active lupus nephritis. The main goal is to see what percentage of participants achieve a complete renal response (meaning their kidney disease improves significantly) after 6 months. The study plans to enroll 35 participants, but its current recruitment status is unclear.

Study design
This is a Phase 2 interventional study, meaning all participants will receive the obe-cel treatment. It plans to enroll 35 participants.
What's involved
You would go through a screening period, then a treatment period where you receive lymphodepletion and a single obe-cel infusion. After treatment, you will have follow-up visits for safety and effectiveness evaluations.
Compensation
Not stated in the trial record.
Follow-up
All participants will be followed up for efficacy and safety evaluation from Day 1 until the end of the study. The primary endpoint is measured at Month 6.

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NCT07053800

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

Recruiting
PHASE2Ages 12–65InterventionalTreatment
Autolus Limited
~35 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Obecabtagene autoleucel

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who achieve complete renal response (CRR)
Measured over Month 6

Conditions

Lupus Nephritis

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Where it's being run

15 sites across 6 states
United Kingdom8
New York2
Greece2
Texas1
Estado de Bahia1
Vietnam1

Who to contact

Autolus Ltd
[email protected]
+44 (0)203 911 4385
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of participants who achieve complete renal response (CRR)Month 6

    CRR is a composite endpoint