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NCT07053800PHASE2Recruiting

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

Autolus Limited

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

Inclusion Criteria: * 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 Criteria: * 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

Interventions

BIOLOGICAL

Obecabtagene autoleucel

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Conditions

Lupus Nephritis

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