TrialPath
Recruiting

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

NCT07053800 · Autolus Limited
In plain English

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Official title
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
About this study
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
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
Study design
Enrollment target: 35 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2026-01-16
Estimated completion: 2029-10
Last updated: 2026-07-06
Interventions
Biological: Obecabtagene autoleucel
Primary outcomes
  • Proportion of participants who achieve complete renal response (CRR) (Month 6)
Sponsor
Autolus Limited · industry
With: PPD Development, LP
Contacts & investigators
ContactAutolus Ltd · contact · clinicaltrials@autolus.com · +44 (0)203 911 4385
All locations (12)
State University of New York Upstate Medical Center (SUNY)Recruiting
Syracuse, New York, United States
Texas Transplant InstituteRecruiting
San Antonio, Texas, United States
University General Hospital ATTIKONRecruiting
Athens, Greece
University General Hospital of PatrasRecruiting
Pátrai, Greece
Queen Elizabeth Hospital BirminghamRecruiting
Birmingham, United Kingdom
Bristol Haematology and Oncology CentreRecruiting
Bristol, United Kingdom
Addenbrooke's HospitalRecruiting
Cambridge, United Kingdom
Western General Hospital EdinburghRecruiting
Edinburgh, United Kingdom
Queen Elizabeth University HospitalRecruiting
Glasgow, United Kingdom
University College HospitalRecruiting
London, United Kingdom
Great Ormond Street HospitalRecruiting
London, United Kingdom
Manchester Royal InfirmaryRecruiting
Manchester, United Kingdom
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN) · TrialPath