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

Recruiting now · Phase 2

Conditions studied: Lupus Nephritis

In brief

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).

Key facts

Study ID

NCT07053800

Run by

Autolus Limited

People needed

35

Starts

2026-01-16

Expected to finish

2029-10-01

Last updated by the study team

2026-07-31

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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:
• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• State University of New York Upstate Medical Center (SUNY) — Syracuse, New York, United States (enrolling)
• Texas Transplant Institute — San Antonio, Texas, United States (enrolling)
• Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael — Salvador, Estado de Bahia, Brazil (enrolling)
• University General Hospital ATTIKON — Athens, Greece (enrolling)
• University General Hospital of Patras — Pátrai, Greece (enrolling)
• Queen Elizabeth Hospital Birmingham — Birmingham, United Kingdom (enrolling)
• Bristol Haematology and Oncology Centre — Bristol, United Kingdom (enrolling)
• Addenbrooke's Hospital — Cambridge, United Kingdom (enrolling)
• Western General Hospital Edinburgh — Edinburgh, United Kingdom (enrolling)
• Queen Elizabeth University Hospital — Glasgow, United Kingdom (enrolling)
• University College Hospital — London, United Kingdom (enrolling)
• Great Ormond Street Hospital — London, United Kingdom (enrolling)
• Manchester Royal Infirmary — Manchester, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.