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Clinical Trials in the USA / NCT07053800
Recruiting Phase 2

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

NCT07053800 · tracked via the Priya Life Science USA tracker
Sponsor
Autolus Limited
Phase
Phase 2
Started
2026-01-16
Last updated
2026-08-24

Condition(s) studied

Lupus Nephritis

Investigational drug(s) / intervention(s)

Obecabtagene autoleucel

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

Study 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

Sex
ALL
Min age
12 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Icahn School of Medicine at Mount Sinai New York New York Recruiting
State University of New York Upstate Medical Center (SUNY) Syracuse New York Recruiting
Texas Transplant Institute San Antonio Texas Recruiting
Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael Salvador Estado de Bahia Recruiting
University General Hospital ATTIKON Athens Greece Recruiting
University General Hospital of Patras Pátrai Greece Recruiting
Queen Elizabeth Hospital Birmingham Birmingham United Kingdom Recruiting
Bristol Haematology and Oncology Centre Bristol United Kingdom Recruiting
Addenbrooke's Hospital Cambridge United Kingdom Recruiting
Western General Hospital Edinburgh Edinburgh United Kingdom Recruiting
Queen Elizabeth University Hospital Glasgow United Kingdom Recruiting
University College Hospital London United Kingdom Recruiting
Great Ormond Street Hospital London United Kingdom Recruiting
Manchester Royal Infirmary Manchester United Kingdom Recruiting
Vinmec Hospital Hà Nội Vietnam Recruiting

More Autolus Limited trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07053800 on ClinicalTrials.gov ↗ ← All trials in the USA