Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Start Date
1/16/2026
Completion Date
10/1/2029
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).
Detailed Description
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.
Eligibility Criteria
Age Range: 12 years to 65 years
Interventions
Obecabtagene autoleucel
Conditions
Locations
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
State University of New York Upstate Medical Center (SUNY)
Syracuse, New York 13210
United States
Texas Transplant Institute
San Antonio, Texas 78229
United States
Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia 41253-190
Brazil
University General Hospital ATTIKON
Athens, 12461
Greece
University General Hospital of Patras
Pátrai, 26504
Greece
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS1 3LH
United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United Kingdom
Western General Hospital Edinburgh
Edinburgh, EH4 2XU
United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF
United Kingdom
University College Hospital
London, MW1 2PG
United Kingdom
Great Ormond Street Hospital
London, WC1N 3JH
United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL
United Kingdom