Kidney Week

Abstract: INFO04-SA

LUMINA: A Phase 2 Trial in Progress Evaluating the Safety and Efficacy of Obecabtagene Autoleucel in Severe, Refractory Systemic Lupus Erythematosus with Active Lupus Nephritis

Session Information

• Informational Posters - 3
  October 24, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• No subcategory defined

Authors

• Lipsitt, Amanda Elise, Methodist Hospital, Methodist Healthcare System of San Antonio, San Antonio, Texas, United States

Amanda Elise Lipsitt, MD

• Perl, Andras, State University of New York Upstate Medical University, Syracuse, New York, United States

Andras Perl

• Parker, Ben, Kellgren Centre for Rheumatology, NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, United Kingdom

Ben Parker, MBChB, PhD

• Jayne, David R.W., Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, United Kingdom

David R.W. Jayne, MD, MBChB

• Campbell, Victoria, Western General Hospital, Edinburgh, United Kingdom

Victoria Campbell, MBBS, PhD

• Ferguson, Paul, Queen Elizabeth Hospital, Birmingham, United Kingdom

Paul Ferguson

• Padmanabhan, Neal, NHS Greater Glasgow and Clyde-Queen Elizabeth University Hospital, Glasgow, United Kingdom

Neal Padmanabhan, MBChB, PhD

• Power, Albert J., Southmead Hospital, North Bristol NHS Trust, Bristol, United Kingdom

Albert J. Power, MD, MBChB

• M F Silva, Juliana, Great Ormond Street Hospital for Children NHS Foundation Trust, London, England, United Kingdom

Juliana M F Silva

• Basilico, Silvia, Autolus Therapeutics, Basel, Switzerland

Silvia Basilico

• Dhungana, Neema, Autolus Therapeutics, Rockville, Maryland, United States

Neema Dhungana

• Germano, Davide, Autolus Therapeutics, Basel, Switzerland

Davide Germano

• Hu, Yanqing, Autolus Therapeutics, Rockville, Maryland, United States

Yanqing Hu, PhD

• Pena Rossi, Claudia, Autolus Therapeutics, Basel, Switzerland

Claudia Pena Rossi

• Ziznevska, Olga, Autolus Therapeutics, Basel, Switzerland

Olga Ziznevska

• Leandro, Maria, University College London, London, United Kingdom

Maria Leandro, MD, PhD

Description

Obecabtagene autoleucel (obe-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy with a 4-1BB-ζ costimulatory domain and a fast off-rate target antigen binding domain, approved for adult relapsed/refractory B-cell acute lymphoblastic leukemia. Preliminary findings from the dose-finding Phase I CARLYSLE study (NCT06333483), evaluating obe-cel in patients with severe, refractory systemic lupus erythematosus (srSLE), suggest a manageable safety profile, clinical benefit, and evidence of deep B-cell depletion and potential immune reset following infusion. LUMINA (NCT07053800) is an ongoing Phase II, multicenter, single-arm, open-label trial designed to evaluate obe-cel in patients with srSLE and active lupus nephritis (LN).

The trial is enrolling patients aged 12–65 years with srSLE fulfilling the 2019 EULAR/ACR criteria, a ≥8-point SLE Disease Activity Index 2000 (SLEDAI-2K) score and positivity for ≥1 autoantibody, who are refractory to standard-of-care treatments. Patients must have ongoing class III, IV, or V (class V only in combination with class III/IV) LN, that is active or active/chronic, based on a renal biopsy obtained within 6 months before screening (or during) screening, urine protein-creatinine ratio (UPCR) >1 mg/mg from a 24-hour urine collection, and an estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73 m².

Patients may receive permitted medication as bridging therapy to control the disease, if needed, after enrollment and before lymphodepletion with fludarabine and cyclophosphamide. Obe-cel will then be administered as a single infusion at a flat dose of 50×10⁶ (± 25%) CAR T-cells. Approximately 35 patients are expected to be enrolled and followed for at least 24 months after obe-cel infusion.

The primary endpoint is complete renal response (CRR) at Month 6, defined as UPCR ≤0.5 mg/mg and eGFR ≥60 mL/min/1.73 m² (or no decrease from baseline eGFR of >20%), with no rescue medications including background immunosuppressants. Secondary endpoints include Definition of Remission in SLE (DORIS) remission, CRR and partial renal response rates, change in SLEDAI-2K score, pharmacokinetics, and safety (all up to Month 24).

Recruitment is ongoing across sites in the US and UK. Additional sites are planned in Vietnam, Brazil, and Greece.

Acknowledgment

This study was sponsored by Autolus Therapeutics PLC. Third-party medical writing assistance, under the direction of authors, was provided by Jayden Collison, MSc, of Ashfield MedComms (Cape Town, South Africa), an Inizio company, and was funded by Autolus Therapeutics PLC.

Funding

• Autolus Therapeutics PLC