Tests obe-cel cell therapy in lupus with active kidney inflammation
Tests obe-cel, a single infusion, in people with severe lupus and kidney inflammation.
Plain-language title generated from the registry record
Registry title: Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Key facts
- Where
- Salvador, BrazilSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 to 65 with severe lupus (SLE) and active lupus nephritis that did not improve with earlier treatments. They receive one dose of obe-cel, a cell therapy.
- Age
- 12 to 65 years
- Sex
- All sexes. Women cannot be pregnant or breastfeeding.
- Disease stage
- Severe, active SLE (SLEDAI-2K score of 8 or more) with active lupus nephritis shown on kidney biopsy (Class III, IV, or V only together with III or IV).
- Earlier treatment
- Earlier lupus treatments must have failed. Anyone who ever had anti-CD19 therapy cannot join.
- Biomarker or test result
- Positive for at least 1 of these antibodies: ANA, anti-dsDNA or anti-Smith.
Main reasons for not taking part
- Earlier anti-CD19 therapy
- Likely irreversible organ damage from SLE, such as end-stage kidney disease
- Primary antiphospholipid antibody syndrome
- Active or uncontrolled fungal, bacterial or viral infection
- Earlier heart, lung, kidney, liver or stem cell transplant
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 65 years old?
Source: NCT07053800, who can take part
Where in Brazil
- Instituto D'Or de Pesquisa e Ensino - Hospital Sao RafaelSalvador, BrazilContact: Autolus LtdTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Autolus Limited
- Trial code
- NCT07053800EU 2024-519941-32-00
- Record updated
- 30 October 2026
- Original description
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 full original descriptionShow less
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).
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.