RecruitingPhase 2NCT07053800

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

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

Sponsor

Autolus Limited

Enrollment

35 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

Lupus Nephritis

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).

Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Obecabtagene autoleucel for people with lupus nephritis. The study is currently recruiting participants at 26 locations. People eligible for this study include aged 12 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALObecabtagene autoleucel

Obecabtagene autoleucel (obe-cel) given as a single infusion

Locations(10)

State University of New York Upstate Medical Center (SUNY)

Syracuse, New York, United States

Texas Transplant Institute

San Antonio, Texas, United States

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Western General Hospital Edinburgh

Edinburgh, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

University College Hospital

London, United Kingdom

Great Ormond Street Hospital

London, United Kingdom

Manchester Royal Infirmary

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07053800

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